Page last updated: 2024-10-18

dalteparin and Kidney Diseases

dalteparin has been researched along with Kidney Diseases in 43 studies

Dalteparin: A low-molecular-weight fragment of heparin, prepared by nitrous acid depolymerization of porcine mucosal heparin. The mean molecular weight is 4000-6000 daltons. It is used therapeutically as an antithrombotic agent. (From Merck Index, 11th ed)

Kidney Diseases: Pathological processes of the KIDNEY or its component tissues.

Research Excerpts

ExcerptRelevanceReference
"Oral dabigatran etexilate is indicated for the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement or total hip replacement."7.76Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism in patients aged over 75 years or with moderate renal impairment undergoing total knee or hip replacement. ( Brenkel, IJ; Clemens, A; Dolan, G; Noack, H; Plumb, JM; Robinson, PA; Roskell, NS; Wolowacz, SE, 2010)
" This analysis supports dosing patients with renal impairment in accordance with patients with normal renal function; however, anti-Xa monitoring could be considered to further support safety in selected patients, particularly those with very severe renal impairment."6.82A post hoc analysis of dalteparin versus oral anticoagulant (VKA) therapy for the prevention of recurrent venous thromboembolism (rVTE) in patients with cancer and renal impairment. ( Abreu, P; Feugère, G; Heissler, J; Jen, F; Ruiz, MT; Woodruff, S, 2016)
"A model-based approach was used to integrate data from a phase II study in order to provide a quantitative rationale for selecting the apixaban dosage regimen for a phase III trial."5.36Quantification of apixaban's therapeutic utility in prevention of venous thromboembolism: selection of phase III trial dose. ( Feng, Y; Leil, TA; Mohan, P; Paccaly, A; Pfister, M; Zhang, L, 2010)
"Oral dabigatran etexilate is indicated for the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement or total hip replacement."3.76Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism in patients aged over 75 years or with moderate renal impairment undergoing total knee or hip replacement. ( Brenkel, IJ; Clemens, A; Dolan, G; Noack, H; Plumb, JM; Robinson, PA; Roskell, NS; Wolowacz, SE, 2010)
"RI in patients with cancer-associated thrombosis on anticoagulation was associated with a statistically significant increase in recurrent VTE and major bleeding, but no significant increase in CRB or mortality."2.87Renal Impairment, Recurrent Venous Thromboembolism and Bleeding in Cancer Patients with Acute Venous Thromboembolism-Analysis of the CATCH Study. ( Bauersachs, R; Janas, MS; Jarner, MF; Kamphuisen, PW; Khorana, AA; Lee, AYY; Meyer, G, 2018)
" This analysis supports dosing patients with renal impairment in accordance with patients with normal renal function; however, anti-Xa monitoring could be considered to further support safety in selected patients, particularly those with very severe renal impairment."2.82A post hoc analysis of dalteparin versus oral anticoagulant (VKA) therapy for the prevention of recurrent venous thromboembolism (rVTE) in patients with cancer and renal impairment. ( Abreu, P; Feugère, G; Heissler, J; Jen, F; Ruiz, MT; Woodruff, S, 2016)
" It is a hydrophilic molecule that is, predominantly, eliminated renally with few data to support dosing for subjects with renal impairment and/or obesity."2.75Individualized dosing of enoxaparin for subjects with renal impairment is superior to conventional dosing at achieving therapeutic concentrations. ( Atherton, JJ; Barras, MA; Duffull, SB; Green, B, 2010)
"Data were obtained from a randomized controlled trial (n = 118) that compared conventional dosing of enoxaparin (product label) with an individualized dosing regimen."2.74Modelling the occurrence and severity of enoxaparin-induced bleeding and bruising events. ( Atherton, JJ; Barras, MA; Duffull, SB; Green, B, 2009)
"Dalteparin was injected s."2.74Study of bioaccumulation of dalteparin at a prophylactic dose in patients with various degrees of impaired renal function. ( Brodmann, D; Fischer, AG; Schmid, P; Wuillemin, WA, 2009)
"The aims of this study were to investigate the influence of glomerular filtration rate (GFR) on the pharmacokinetics of subcutaneously administered enoxaparin, and to develop a practical dosing algorithm in renal impairment that can easily be used at the bedside."2.71Dosing strategy for enoxaparin in patients with renal impairment presenting with acute coronary syndromes. ( Atherton, J; Green, B; Greenwood, M; Kluver, L; Rowell, J; Saltissi, D; Westhuyzen, J, 2005)
"Subjects were administered dalteparin at a dosage of approximately 100 U/kg subcutaneously every 12 hours."2.71Peak antifactor xa activity produced by dalteparin treatment in patients with renal impairment compared with controls. ( Billett, HH; Cheng-Lai, A; Cohen, HW; Madsen, EM; Shprecher, AR; Sinnett, MJ; Wong, ST, 2005)
" Recently, the use of safe-dose recombinant tissue-type plasminogen activator (rTPA) has been proposed for the treatment of moderate PE demonstrating to be safe and more effective than standard anticoagulation."2.50[Safe dose rTPA for massive pulmonary embolism associated with high bleeding risk: a case report and review of the literature]. ( Cannone, M; La Torre, PP; Mele, A; Mele, M, 2014)
" Compared with unfractionated heparin (UFH), nadroparin has a greater ratio of anti-factor Xa to anti-factor Ha activity, greater bioavailability and a longer duration of action, allowing it to be administered by subcutaneous injection for prophylaxis or treatment of thromboembolic disorders."2.40Nadroparin calcium. A review of its pharmacology and clinical use in the prevention and treatment of thromboembolic disorders. ( Davis, R; Faulds, D, 1997)
"The management of a patient with venous thrombosis with perinephric hematoma post renal biopsy can be difficult if occurred."1.72Double trouble - management of perinephric hematoma and renal vein thrombosis post percutaneous renal biopsy. ( Daud, MAM; Kamarudin, MI; Nadarajan, C, 2022)
"Only cases with renal failure, morbid obesity or extreme age require anti-Xa monitoring to assure the therapeutic level achievement."1.36Stability of plasma anti-Xa activity in low-molecular-weight heparin monitoring. ( Akkawat, B; Juntiang, J; Rojnuckarin, P, 2010)
"A model-based approach was used to integrate data from a phase II study in order to provide a quantitative rationale for selecting the apixaban dosage regimen for a phase III trial."1.36Quantification of apixaban's therapeutic utility in prevention of venous thromboembolism: selection of phase III trial dose. ( Feng, Y; Leil, TA; Mohan, P; Paccaly, A; Pfister, M; Zhang, L, 2010)
"Subjects with ESRD had an approximately 50% greater anticoagulant effect, determined by thrombin generation time prolongation, than controls at antifactor Xa activity concentrations of 0."1.32Enhanced anticoagulant activity of enoxaparin in patients with ESRD as measured by thrombin generation time. ( Brophy, DF; Carr, ME; Gehr, TW; Martin, EJ, 2004)
"There are limited data on dosing of enoxaparin in patients with renal disease due to the routine exclusion of this population in clinical trials."1.32Anti-Xa monitoring of enoxaparin for acute coronary syndromes in patients with renal disease. ( Jackevicius, CA; Ma, JM; Yeo, E, 2004)
" Only pharmacokinetic studies exist to guide dose adjustment in response to anti-Xa levels."1.32Retrospective evaluation of a pharmacokinetic program for adjusting enoxaparin in renal impairment. ( Kruse, MW; Lee, JJ, 2004)

Research

Studies (43)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's1 (2.33)18.2507
2000's20 (46.51)29.6817
2010's19 (44.19)24.3611
2020's3 (6.98)2.80

Authors

AuthorsStudies
Derlatka, P1
Bidzinski, M1
Stachurska, E1
Benke, M1
Davis, R1
Faulds, D1
Del Peso, G1
Bajo, MA1
Fontán, MP1
Martínez, J1
Marrón, B1
Selgas, R1
Christidou, FN1
Frangia, TK1
Bamichas, GI1
Gionanlis, LC1
Natse, TA1
Georgoulis, IE1
Sombolos, KI1
Faour, WH1
Choaib, A1
Issa, E1
Choueiry, FE1
Shbaklo, K1
Alhajj, M1
Sawaya, RT1
Harhous, Z1
Alefishat, E1
Nader, M1
Kamarudin, MI1
Nadarajan, C1
Daud, MAM1
Weitz, JI1
Raskob, GE1
Spyropoulos, AC1
Spiro, TE1
De Sanctis, Y1
Xu, J1
Lu, W1
Suh, E1
Argenti, D1
Yang, H1
Albanese, J1
Lipardi, C1
Barnathan, ES1
Gökce, M1
Kuskonmaz, B1
Cetin, M1
Uckan Cetinkaya, D1
Tuncer, M1
Mele, M1
Mele, A1
La Torre, PP1
Cannone, M1
Freer, JM1
Green, MS1
Iuppa, JA1
Deal, EN1
Thoelke, MS1
Sacha, GL1
Greenlee, KM1
Ketz, JM1
Al-Sallami, H1
Ferguson, R1
Wilkins, G1
Gray, A1
Medlicott, NJ1
White, HD1
Gallo, R1
Cohen, M2
Steg, PG1
Aylward, PE1
Bode, C1
Steinhubl, S1
Montalescot, G1
Rojnuckarin, P1
Akkawat, B1
Juntiang, J1
Barras, MA2
Duffull, SB2
Atherton, JJ2
Green, B3
Wolowacz, SE1
Roskell, NS1
Plumb, JM1
Clemens, A1
Noack, H1
Robinson, PA1
Dolan, G1
Brenkel, IJ1
Leil, TA1
Feng, Y1
Zhang, L1
Paccaly, A1
Mohan, P1
Pfister, M1
Tsang, DJ1
Tuckfield, A1
Macisaac, CM1
Dufour, B1
Toussaint-Hacquard, M1
Kearney-Schwartz, A1
Manckoundia, MD1
Laurain, MC1
Joly, L1
Deibener, J1
Wahl, D1
Lecompte, T1
Benetos, A1
Perret-Guillaume, C1
Spinler, SA1
Inverso, SM1
Goodman, SG1
Stringer, KA1
Antman, EM1
Borawski, J1
Naumnik, B1
Myśliwiec, M1
Brophy, DF2
Martin, EJ2
Gehr, TW2
Carr, ME2
Best, AM1
Ma, JM1
Jackevicius, CA1
Yeo, E1
Kruse, MW1
Lee, JJ1
Kozlovskaia, NL1
Shakhnova, EA1
Kushnir, VV1
Shilov, EM1
Greenwood, M1
Saltissi, D1
Westhuyzen, J1
Kluver, L1
Rowell, J1
Atherton, J1
Nagge, J1
Fernandes, O1
Huh, J1
Spinler, S1
Nasser, NJ1
Abadi, S1
Azzam, ZS1
Lile, J1
Woodruff, S1
Feugère, G1
Abreu, P1
Heissler, J1
Ruiz, MT1
Jen, F1
Schmid, P1
Brodmann, D1
Fischer, AG1
Wuillemin, WA1
Haines, ST1
Dager, WE1
Trujillo, TC1
Näsström, B1
Stegmayr, B1
Olivecrona, G2
Olivecrona, T2
Shprecher, AR1
Cheng-Lai, A1
Madsen, EM1
Cohen, HW1
Sinnett, MJ1
Wong, ST1
Billett, HH1
Bauersachs, R1
Lee, AYY1
Kamphuisen, PW1
Meyer, G1
Janas, MS1
Jarner, MF1
Khorana, AA1
Mahmood, D3
Stegmayr, BG3
Projean, D1
Lalonde, S1
Morin, J1
Nogues, E1
Séguin, A1
Vincent, A1
Lafrance, JP1
Masson, V1
Kassis, J1
Fafard, J1
Lordkipanidzé, M1
Grubbström, M1
Lundberg, LD1
Siguret, V1
Gouin-Thibault, I1
Pautas, E1
Leizorovicz, A1
Jonsson, P1

Clinical Trials (6)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study[NCT00571649]Phase 38,101 participants (Actual)Interventional2007-12-31Completed
Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk[NCT02111564]Phase 312,024 participants (Actual)Interventional2014-01-07Completed
An International Phase 2-3, Stratified, Randomized, Open-label, Parallel-group Clinical Trial to Evaluate the Safety and Efficacy of a Single Intravenous Bolus of Enoxaparin Versus Intravenous Unfractionated Heparin in Patients Undergoing Non-emergent Per[NCT00077844]Phase 2/Phase 33,532 participants (Anticipated)Interventional2004-01-31Completed
Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function[NCT00264693]96 participants (Actual)Observational2006-01-31Completed
Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation With a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT[NCT01130025]Phase 3900 participants (Actual)Interventional2010-08-31Completed
Study of the Bioaccumulation of Tinzaparin in Renally Impaired Patients When Given at Prophylactic Doses[NCT02719418]28 participants (Actual)Observational2016-02-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days

A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death. (NCT00571649)
Timeframe: Up to Day 35 + 6 days

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)4.4
Enoxaparin5.7

Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days

A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related). (NCT00571649)
Timeframe: Up to Day 35 + 6 days

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)8.6
Enoxaparin9.2

Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days

A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death. (NCT00571649)
Timeframe: Up to Day 10 + 5 days

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)2.7
Enoxaparin2.7

Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population

A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death. (NCT00571649)
Timeframe: Up to Day 10 + 5 days

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)3.0
Enoxaparin3.1

Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 10 + 5 Days

Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events (NCT00571649)
Timeframe: Up to Day 10 + 5 days

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)4.5
Enoxaparin3.9

Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days

Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events. (NCT00571649)
Timeframe: Up to Day 35 + 6 days

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)9.4
Enoxaparin7.8

Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days)

Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin or transfusion of >=2 units of packed RBCs or whole blood or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding. (NCT00571649)
Timeframe: Up to Day 10 + 5 days

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)2.8
Enoxaparin1.2

Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days)

Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin; or transfusion of >= 2 units of packed RBCs (Red blood cells) or whole blood; or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding (NCT00571649)
Timeframe: Up to Day 35 + 6 days

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)4.1
Enoxaparin1.7

Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days

A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related). (NCT00571649)
Timeframe: Up to Day 10 + 5 days

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)4.8
Enoxaparin4.5

Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days

All deaths, including VTE-related deaths, cardiovascular deaths, and other deaths. (NCT00571649)
Timeframe: Up to Day 90 + 7 days

,
InterventionPercentage of participants (Number)
Any eventDeath (cardiovascular)Death (other)VTE related death
Enoxaparin6.21.43.71.1
Rivaroxaban (Xarelto, BAY59-7939)6.71.44.31.0

Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days

The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death. (NCT00571649)
Timeframe: Up to Day 10 + 5 days

,
InterventionPercentage of participants (Number)
Symptomatic non-fatal PESymptomatic DVT in lower extremityAsymptomatic proximal DVT in lower extremityVTE related death
Enoxaparin0.10.22.40.2
Rivaroxaban (Xarelto, BAY59-7939)0.20.22.40.1

Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days

The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death. (NCT00571649)
Timeframe: Up to Day 35 + 6 days

,
InterventionPercentage of participants (Number)
Symptomatic non-fatal PESymptomatic DVT in lower extremityAsymptomatic proximal DVT in lower extremityVTE related death
Enoxaparin0.50.54.41.0
Rivaroxaban (Xarelto, BAY59-7939)0.30.43.50.6

Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90

Major vascular events included cardiovascular death, acute myocardial infarction (MI), or acute ischemic stroke. Participants may have had a vascular event in more than one category. (NCT00571649)
Timeframe: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days

,
InterventionPercentage of participants (Number)
Any event-Day 10Ischemic stroke-Day 10Acute MI-Day 10Death (cardiovascular)-Day 10Any event-Day 35Ischemic stroke-Day 35Acute MI-Day 35Death (cardiovascular)-Day 35Any event-Day 90Ischemic stroke-Day 90Acute MI-Day 90Death (cardiovascular)-Day 90
Enoxaparin1.00.30.40.41.60.50.50.82.81.10.71.4
Rivaroxaban (Xarelto, BAY59-7939)1.00.30.50.41.80.50.60.92.80.80.91.4

Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90

Symptomatic VTE (non-fatal PE and DVT in lower extremity), including and excluding VTE-related death (PE and PE cannot be excluded) up to Days 10, 35, and 90 (NCT00571649)
Timeframe: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days

,
InterventionPercentage of participants (Number)
symptomatic VTE (incl. VTE-related death)-Day 10symptomatic VTE (non fatal)-Day 10symptomatic VTE (incl. VTE-related death)-Day 35symptomatic VTE (non fatal)-Day 35symptomatic VTE (incl. VTE-related death)-Day 90symptomatic VTE (non fatal)-Day 90
Enoxaparin0.60.31.40.71.90.9
Rivaroxaban (Xarelto, BAY59-7939)0.70.51.00.61.70.7

Event Rate Based on Time From Randomization to First Occurrence of All-Cause Mortality (ACM) Adjudicated by CEC

Event rate based on time from randomization to first occurrence of ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45

InterventionEvents per 100 participants in 45 days (Number)
Rivaroxaban 10 mg or 7.5 mg1.19
Placebo1.49

Event Rate Based on Time From Randomization to First Occurrence of VTE-Related Death Adjudicated by CEC

Event rate based on time from randomization to first occurrence of VTE-related death (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45

InterventionEvents per 100 participants in 45 days (Number)
Rivaroxaban 10 mg or 7.5 mg0.72
Placebo0.77

Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE and All-Cause Mortality (ACM) Adjudicated by CEC

Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE and ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45

InterventionEvents per 100 participants in 45 days (Number)
Rivaroxaban 10 mg or 7.5 mg1.31
Placebo1.80

Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE, Myocardial Infarction (MI), Non-Hemorrhagic Stroke, and Cardiovascular (CV) Death Adjudicated by CEC

Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE (lower extremity DVT and non-fatal PE), MI, non-hemorrhagic stroke, and CV death (death due to a known CV cause and death in which a CV cause cannot be ruled out; by this definition, a VTE-related death was considered a CV death) as adjudicated by CEC was reported. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45

InterventionEvents per 100 participants in 45 days (Number)
Rivaroxaban 10 mg or 7.5 mg1.58
Placebo2.03

Event Rate Based on Time From Randomization to the First Occurrence of a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC

Event rate based on time from randomization to the first occurrence of a symptomatic VTE (adjudicated by CEC) was assessed. Symptomatic VTE included lower extremity DVT and non-fatal PE. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45

InterventionEvents per 100 participants in 45 days (Number)
Rivaroxaban 10 mg or 7.5 mg0.19
Placebo0.42

Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC

A major bleeding event was defined using validated International Society on Thrombosis and Haemostasis (ISTH) bleeding criteria. A major bleeding event was defined as overt bleeding that was associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or a critical site defined as intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or a fatal outcome. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or last dose + 2 days. (NCT02111564)
Timeframe: From randomization to 2 days after the last dose (Day 45)

InterventionEvents per 100 participants in 45 days (Number)
Rivaroxaban 10 mg or 7.5 mg0.28
Placebo0.15

Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC)

Symptomatic VTE included lower extremity deep vein thrombosis (DVT) and non-fatal pulmonary embolism (PE). Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45

InterventionEvents per 100 participants in 45 days (Number)
Rivaroxaban 10 mg or 7.5 mg0.84
Placebo1.11

Reviews

3 reviews available for dalteparin and Kidney Diseases

ArticleYear
Nadroparin calcium. A review of its pharmacology and clinical use in the prevention and treatment of thromboembolic disorders.
    Drugs & aging, 1997, Volume: 10, Issue:4

    Topics: Absorption; Aging; Anticoagulants; Chemical Fractionation; Cost-Benefit Analysis; Dose-Response Rela

1997
Mechanisms of COVID-19-induced kidney injury and current pharmacotherapies.
    Inflammation research : official journal of the European Histamine Research Society ... [et al.], 2022, Volume: 71, Issue:1

    Topics: Acute Kidney Injury; Aldosterone; Angiotensins; Antibodies, Monoclonal, Humanized; Autopsy; Biopsy;

2022
[Safe dose rTPA for massive pulmonary embolism associated with high bleeding risk: a case report and review of the literature].
    Giornale italiano di cardiologia (2006), 2014, Volume: 15, Issue:4

    Topics: Aged, 80 and over; Anemia, Hypochromic; Anticoagulants; Bundle-Branch Block; Diabetes Complications;

2014

Trials

17 trials available for dalteparin and Kidney Diseases

ArticleYear
Nadroparine activated fibrinolysis and improvement of glomerular filtration rate in patients with FIGO IIB-IIIB cervical cancer treated with radiochemotherapy.
    Gynecologic oncology, 2007, Volume: 104, Issue:1

    Topics: Adult; Aged; Aged, 80 and over; Cisplatin; Combined Modality Therapy; Female; Fibrinolysis; Fibrinol

2007
Effect of self-administered intraperitoneal bemiparin on peritoneal transport and ultrafiltration capacity in peritoneal dialysis patients with membrane dysfunction. A randomized, multi-centre open clinical trial.
    Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2012, Volume: 27, Issue:5

    Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Female; Hemorrhage; Heparin, Low-Molecular-Weight; H

2012
Comparison of two low-molecular weight heparins (LMWHs), tinzaparin and bemiparin, during hemodialysis.
    International journal of clinical pharmacology and therapeutics, 2005, Volume: 43, Issue:7

    Topics: Adult; Blood Coagulation; Chronic Disease; Drug Administration Schedule; Factor Xa; Factor Xa Inhibi

2005
Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials.
    Thrombosis and haemostasis, 2020, Volume: 120, Issue:3

    Topics: Acute Disease; Aged; Anticoagulants; Double-Blind Method; Enoxaparin; Female; Hemorrhage; Humans; In

2020
Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials.
    Thrombosis and haemostasis, 2020, Volume: 120, Issue:3

    Topics: Acute Disease; Aged; Anticoagulants; Double-Blind Method; Enoxaparin; Female; Hemorrhage; Humans; In

2020
Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials.
    Thrombosis and haemostasis, 2020, Volume: 120, Issue:3

    Topics: Acute Disease; Aged; Anticoagulants; Double-Blind Method; Enoxaparin; Female; Hemorrhage; Humans; In

2020
Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials.
    Thrombosis and haemostasis, 2020, Volume: 120, Issue:3

    Topics: Acute Disease; Aged; Anticoagulants; Double-Blind Method; Enoxaparin; Female; Hemorrhage; Humans; In

2020
The use of intravenous enoxaparin in elective percutaneous coronary intervention in patients with renal impairment: results from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial.
    American heart journal, 2009, Volume: 157, Issue:1

    Topics: Aged; Angioplasty, Balloon, Coronary; Anticoagulants; Elective Surgical Procedures; Enoxaparin; Fema

2009
Modelling the occurrence and severity of enoxaparin-induced bleeding and bruising events.
    British journal of clinical pharmacology, 2009, Volume: 68, Issue:5

    Topics: Anticoagulants; Dose-Response Relationship, Drug; Enoxaparin; Female; Hemorrhage; Humans; Kidney; Ki

2009
Individualized dosing of enoxaparin for subjects with renal impairment is superior to conventional dosing at achieving therapeutic concentrations.
    Therapeutic drug monitoring, 2010, Volume: 32, Issue:4

    Topics: Algorithms; Anticoagulants; Drug Monitoring; Enoxaparin; Humans; Kidney Diseases; Models, Statistica

2010
Activation of hepatocyte growth factor/activin A/follistatin system during hemodialysis: role of heparin.
    Kidney international, 2003, Volume: 64, Issue:6

    Topics: Activins; Aged; Anticoagulants; Enoxaparin; Enzyme-Linked Immunosorbent Assay; Female; Follistatin;

2003
Dosing strategy for enoxaparin in patients with renal impairment presenting with acute coronary syndromes.
    British journal of clinical pharmacology, 2005, Volume: 59, Issue:3

    Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Anticoagulants; Coronary Disease; Enoxapa

2005
A post hoc analysis of dalteparin versus oral anticoagulant (VKA) therapy for the prevention of recurrent venous thromboembolism (rVTE) in patients with cancer and renal impairment.
    Journal of thrombosis and thrombolysis, 2016, Volume: 42, Issue:4

    Topics: Acenocoumarol; Administration, Oral; Adult; Aged; Aged, 80 and over; Anticoagulants; Dalteparin; Fem

2016
Study of bioaccumulation of dalteparin at a prophylactic dose in patients with various degrees of impaired renal function.
    Journal of thrombosis and haemostasis : JTH, 2009, Volume: 7, Issue:4

    Topics: Aged; Aged, 80 and over; Anticoagulants; Cohort Studies; Dalteparin; Drug-Related Side Effects and A

2009
Peak antifactor xa activity produced by dalteparin treatment in patients with renal impairment compared with controls.
    Pharmacotherapy, 2005, Volume: 25, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Case-Control Studies; Dalteparin; Factor Xa; Female;

2005
Renal Impairment, Recurrent Venous Thromboembolism and Bleeding in Cancer Patients with Acute Venous Thromboembolism-Analysis of the CATCH Study.
    Thrombosis and haemostasis, 2018, Volume: 118, Issue:5

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Drug Administration Schedule; Female; Fibrinolytic Agent

2018
Haemodialysis with Tinzaparin Versus Dialysate Citrate as Anticoagulation.
    Blood purification, 2018, Volume: 46, Issue:3

    Topics: Aged; Aged, 80 and over; Anticoagulants; C-Reactive Protein; Cholesterol, LDL; Citric Acid; Dialysis

2018
Lipoprotein lipase responds similarly to tinzaparin as to conventional heparin during hemodialysis.
    BMC nephrology, 2010, Dec-06, Volume: 11

    Topics: Aged; Biomarkers; Drug Substitution; Female; Follow-Up Studies; Heparin; Heparin, Low-Molecular-Weig

2010
No accumulation of the peak anti-factor Xa activity of tinzaparin in elderly patients with moderate-to-severe renal impairment: the IRIS substudy.
    Journal of thrombosis and haemostasis : JTH, 2011, Volume: 9, Issue:10

    Topics: Aged; Aged, 80 and over; Factor Xa Inhibitors; Female; Fibrinolytic Agents; Heparin, Low-Molecular-W

2011
A significant proportion of patients treated with citrate containing dialysate need additional anticoagulation.
    The International journal of artificial organs, 2013, Volume: 36, Issue:1

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anticoagulants; Blood Coagulation; Citric Acid; Cross-Ov

2013

Other Studies

23 other studies available for dalteparin and Kidney Diseases

ArticleYear
Double trouble - management of perinephric hematoma and renal vein thrombosis post percutaneous renal biopsy.
    BMC nephrology, 2022, 09-09, Volume: 23, Issue:1

    Topics: Adult; Biopsy; Enoxaparin; Gastrointestinal Hemorrhage; Hematoma; Hematuria; Humans; Kidney Diseases

2022
Coexisting or underlying risk factors of hepatic veno-occlusive disease in pediatric hematopoietic stem cell transplant recipients receiving prophylaxis.
    Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation, 2013, Volume: 11, Issue:5

    Topics: Administration, Oral; Adolescent; Age Factors; Amphotericin B; Anticoagulants; Antifungal Agents; Bu

2013
Analysis of enoxaparin dose titration at a large, tertiary teaching facility.
    Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis, 2015, Volume: 21, Issue:8

    Topics: Adult; Aged; Dose-Response Relationship, Drug; Enoxaparin; Female; Hospitals, Teaching; Humans; Kidn

2015
The use of anti-factor Xa monitoring in a selection of patients receiving enoxaparin at a large academic medical center.
    Journal of thrombosis and thrombolysis, 2016, Volume: 42, Issue:4

    Topics: Adult; Aged; Aged, 80 and over; Drug Monitoring; Enoxaparin; Factor Xa Inhibitors; Female; Humans; K

2016
Bleeding events in patients receiving enoxaparin for the management of non-ST-elevation acute coronary syndrome (NSTEACS) at Dunedin Public Hospital, New Zealand.
    The New Zealand medical journal, 2008, Nov-07, Volume: 121, Issue:1285

    Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Case-Control Studies; Clinical Trials as Topic; Coro

2008
Stability of plasma anti-Xa activity in low-molecular-weight heparin monitoring.
    Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis, 2010, Volume: 16, Issue:3

    Topics: Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Anticoagulants; Blood Preservation; Child;

2010
Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism in patients aged over 75 years or with moderate renal impairment undergoing total knee or hip replacement.
    Thrombosis and haemostasis, 2010, Volume: 103, Issue:2

    Topics: Aged; Aged, 80 and over; Anticoagulants; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement,

2010
Quantification of apixaban's therapeutic utility in prevention of venous thromboembolism: selection of phase III trial dose.
    Clinical pharmacology and therapeutics, 2010, Volume: 88, Issue:3

    Topics: Aged; Area Under Curve; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Com

2010
Audit of safety and quality of the use of enoxaparin for anticoagulation in continuous renal replacement therapy.
    Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine, 2011, Volume: 13, Issue:1

    Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; APACHE; Enoxaparin; Hemofiltration; Humans; Intensiv

2011
Glomerular filtration rate estimated by Cockcroft-Gault formula better predicts anti-Xa levels than modification of the diet in renal disease equation in older patients with prophylactic enoxaparin.
    The journal of nutrition, health & aging, 2012, Volume: 16, Issue:7

    Topics: Aged; Aged, 80 and over; Anticoagulants; Body Weight; Cohort Studies; Creatinine; Diet; Enoxaparin;

2012
Safety and efficacy of unfractionated heparin versus enoxaparin in patients who are obese and patients with severe renal impairment: analysis from the ESSENCE and TIMI 11B studies.
    American heart journal, 2003, Volume: 146, Issue:1

    Topics: Aged; Anticoagulants; Coronary Disease; Enoxaparin; Female; Fibrinolytic Agents; Heparin; Humans; Ki

2003
Enhanced anticoagulant activity of enoxaparin in patients with ESRD as measured by thrombin generation time.
    American journal of kidney diseases : the official journal of the National Kidney Foundation, 2004, Volume: 44, Issue:2

    Topics: Adult; Anticoagulants; Blood Coagulation; Blood Coagulation Tests; Chronic Disease; Enoxaparin; Fact

2004
Antifactor Xa activity correlates to thrombin generation time, platelet contractile force and clot elastic modulus following ex vivo enoxaparin exposure in patients with and without renal dysfunction.
    Journal of thrombosis and haemostasis : JTH, 2004, Volume: 2, Issue:8

    Topics: Adult; Anticoagulants; Blood Coagulation Tests; Blood Platelets; Chronic Disease; Dose-Response Rela

2004
Anti-Xa monitoring of enoxaparin for acute coronary syndromes in patients with renal disease.
    The Annals of pharmacotherapy, 2004, Volume: 38, Issue:10

    Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Coronary Disease; Drug Administration

2004
Retrospective evaluation of a pharmacokinetic program for adjusting enoxaparin in renal impairment.
    American heart journal, 2004, Volume: 148, Issue:4

    Topics: Aged; Aged, 80 and over; Anticoagulants; Enoxaparin; Factor Xa; Female; Humans; Kidney Diseases; Mal

2004
[Low-molecular heparins in the treatment of APS-nephropathy in primary and secondary antiphospholipid syndrome].
    Terapevticheskii arkhiv, 2004, Volume: 76, Issue:9

    Topics: Adult; Anticoagulants; Antiphospholipid Syndrome; Case-Control Studies; Enoxaparin; Female; Humans;

2004
Evaluation of a pharmacokinetic program for adjusting enoxaparin in renal impairment.
    American heart journal, 2005, Volume: 149, Issue:3

    Topics: Anticoagulants; Enoxaparin; Factor Xa; Humans; Kidney Diseases; Program Evaluation

2005
Adjusting the dose of low molecular weight heparins in renally impaired and obese patients.
    Clinical advances in hematology & oncology : H&O, 2004, Volume: 2, Issue:5

    Topics: Anticoagulants; Biomarkers; Cardiovascular Diseases; Comorbidity; Creatinine; Dose-Response Relation

2004
Acute renal infarction from a cardiac thrombus.
    Nature clinical practice. Nephrology, 2007, Volume: 3, Issue:11

    Topics: Abdominal Pain; Acute Disease; Anticoagulants; Cardiomyopathy, Dilated; Coronary Thrombosis; Diagnos

2007
Low-molecular-weight heparin administration in patients with end-stage renal disease--a comment.
    Pharmacotherapy, 2001, Volume: 21, Issue:8

    Topics: Anticoagulants; Blood Transfusion; Enoxaparin; Hemorrhage; Humans; Kidney Diseases; Kidney Failure,

2001
Clinical and management challenges in preventing venous thromboembolism in health systems: a case-based panel discussion.
    American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2010, May-15, Volume: 67, Issue:10 Suppl 6

    Topics: Aged; Anticoagulants; Arthroplasty, Replacement, Hip; Bariatric Surgery; Colonic Neoplasms; Daltepar

2010
Lipoprotein lipase in hemodialysis patients: indications that low molecular weight heparin depletes functional stores, despite low plasma levels of the enzyme.
    BMC nephrology, 2004, Nov-03, Volume: 5

    Topics: Aged; Area Under Curve; Dalteparin; Heparin; Humans; Kidney Diseases; Lipoprotein Lipase; Reference

2004
Study of the bioaccumulation of tinzaparin in renally impaired patients when given at prophylactic doses - The STRIP study.
    Thrombosis research, 2019, Volume: 174

    Topics: Aged; Aged, 80 and over; Anticoagulants; Humans; Kidney Diseases; Tinzaparin

2019