azathioprine and Infections

azathioprine has been researched along with Infections in 135 studies

Azathioprine: An immunosuppressive agent used in combination with cyclophosphamide and hydroxychloroquine in the treatment of rheumatoid arthritis. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), this substance has been listed as a known carcinogen. (Merck Index, 11th ed)
azathioprine : A thiopurine that is 6-mercaptopurine in which the mercapto hydrogen is replaced by a 1-methyl-4-nitroimidazol-5-yl group. It is a prodrug for mercaptopurine and is used as an immunosuppressant, prescribed for the treatment of inflammatory conditions and after organ transplantation and also for treatment of Crohn's didease and MS.

Infections: Invasion of the host organism by microorganisms or their toxins or by parasites that can cause pathological conditions or diseases.

Research

Studies (135)

Authors

Clinical Trials (20)

Trial Overview

Trial Outcomes

Number of Participants With Major Relapse During the Double-blind Phase of the Study

Data for number of participants with major relapse [defined as experiencing at least 1 major Birmingham Vasculitis Activity Score (BVAS) item] during the double-bind phase of the study was reported. Analysis was performed using a Cox proportional hazard model. (NCT01663623)
Timeframe: Approximately up to 4 years

Time to First Relapse

Time to relapse is defined as the number of days from Day 0 until the participant experienced a relapse (relapse date - treatment start date +1). Only post-baseline relapses were considered in these analyses. Only relapses occurring up to and including the last visit date in the double-blind treatment period were considered in these analyses. Intent-to-treat population comprised of all randomized participants who received at least one dose of study agent (belimumab or placebo). NA indicates that the data was not available as the Number of events is too low to estimate the value. Median and Inter-quartile range were presented and were based on Kaplan Meier estimates. (NCT01663623)
Timeframe: Approximately up to 4 years

Composite of Disease Relapse (Defined a BVAS/WG ≥ 2) and Serious Adverse Events

Number of disease relapse added with the number of SAE in each group (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)

Mean Number of Rituximab Infusions Per Subject

The rituximab utilization was measured in how many times a subject received Rituximab throughout the study which was then averaged for all subjects in each treatment arm, including those who did not receive any infusion. (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)

Number of Major Relapses Defined as a BVAS/WG ≥ 3

The Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG ) is a form with 34 predefined items grouped into 9 organ systems. The items are clinical features observed in patients with active ANCA vasculitis. Each item has a specified weight of either 3 or 1, depending on whether it reflects major or minor disease activity. The total BVAS/WG score is the weighted sum of individual manifestations that are present and believed to be due to active ANCA vasculitis. Higher scores reflect more active disease. BVAS/WG scores range from 0 to 64. (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)

Number of Patients Affected by Serious Adverse Events

Number of patients with serious adverse events (SAEs), including all episodes of late onset neutropenia (LON). SAE are defined in the Serious adverse event section. Serious adverse events were reported over the entire study period (5.5 years) (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)

Number of Patients With Hypogammaglobulinemia

Hypogammaglobulinemia defined as an IgG < 250mg/dL (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)

Patient Survival

number of deaths throughout the study. (NCT02749292)
Timeframe: 5.5 years

Health-related Quality of Life as Assessed by the Short Form Health Survey (SF-36) Scores

The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. (NCT02749292)
Timeframe: Assessed throughout the study period, every 6 months unless such time point was not reached or was missed by the patient. Median follow-up period is of 4.1 years (IQR, 2.5 - 5.0)

Health-related Quality of Life as Assessed by the Short Form Health Survey (SF-36) Scores

The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. (NCT02749292)
Timeframe: Assessed throughout the study period, every 6 months unless such time point was not reached or was missed by the patient. Median follow-up period is of 4.1 years (IQR, 2.5 - 5.0)

Number of Infections

Number of infections mild and severe, whether they were treated or not with antibiotics (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)

Number of Patients With Disease Relapse(s) as Defined by a Birmingham Vasculitis Activity Score for Wegner's Granulomatosis (BVAS/WG) ≥ 2

Relapses recording period was from 6/1/2016 to 12/31/2021. The outcome was reported as the number of participants with disease relapse who had either positive ANCA titers specific for myeloperoxidase (MPO-ANCA) or proteinase 3 (PR3-ANCA). The Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG ) is a form with 34 predefined items grouped into 9 organ systems. The items are clinical features observed in patients with active ANCA vasculitis. Each item has a specified weight of either 3 or 1, depending on whether it reflects major or minor disease activity. The total BVAS/WG score is the weighted sum of individual manifestations that are present and believed to be due to active ANCA vasculitis. Higher scores reflect more active disease. BVAS/WG scores range from 0 to 64. (NCT02749292)
Timeframe: Median follow-up period of 4.1 years (IQR, 2.5 - 5.0)

Organ Damage as Assessed by the Vasculitis Damage Index (VDI).

The Vasculitis Damage Index (VDI) is a validated formal assessment tool in ANCA-associated vasculitis clinical trials. The VDI distinguishes vasculitis-induced chronic damage from active inflammation or persistent disease. Each item represents a disease manifestation and is given a score (of 1) if present for at least 3 months. Neither the cause of damage (vasculitis vs treatment) nor an ongoing activity are taken into consideration. The VDI includes 64 items categorized into 11 groups (by organ system) and the scored items are summed to give a total score ranging from 0 to 64. A higher score means more accrued damage. (NCT02749292)
Timeframe: 3 years starting at inclusion

Number of Participant Fatalities

The number of participant fatalities was evaluated throughout the study. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participants With Demyelinating Neurological Disorders

The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participants With Hematologic Conditions

The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participants With Infusion-Related Reactions/Hypersensitivity

The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participants With Lymphoproliferative Disorders/Malignancies

The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participants With New or Worsening Congestive Heart Failure

The number of participants with new or worsening congestive heart failure was evaluated throughout the study. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participants With Serious Infections

The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii [PCP] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections. (NCT00705614)
Timeframe: Up to 5 Years

Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months

The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months

The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months

The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit. (NCT00705614)
Timeframe: Up to 5 Years

Number of Participants With a Draining Fistula By Study Visit

The number of participants with a draining fistula was evaluated at each study visit. (NCT00705614)
Timeframe: Up to 5 Years

Participant Assessment of Overall Health Status By Study Visit

The participant assessment of overall health status was evaluated at baseline and each study visit. The overall health status questionnaire asked participants to rate their current health status over the prior 24 hours as 1=best possible, 2=much better than average, 3=better than average, 4=average, 5=worse than average, 6=much worse than average, or 7=worst possible. Scores ranged from 1 to 7 with lower scores indicating better health status. (NCT00705614)
Timeframe: Up to 5 Years

The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit

The Harvey-Bradshaw Index of Crohn's Disease Acitivity was evaluated at each study visit. The Harvey-Bradshaw Index evaluates participants' general health in the day prior in the domains of well being, abdominal pain, number of liquid stools per day, and abdominal mass and complications and was evaluated on the day of the study visit. The score is derived from a 0-4 score for general well being, 0-3 for abdmonial pain, raw score for number of liquid stools per day, 0-3 for abdominal mass, and raw score for complications. The total score is from 0 to infinity, with lower scores indicating better outcomes. (NCT00705614)
Timeframe: Up to 5 Years

Work/Daily Activity Status Score By Study Visit

The participant work/daily activity status score was evaluated at each study visit. The work/daily activity questionnaire asked participants to rate their level of daily functioning on a scale of 1 to 10 with a lower score indicating less of an impact of Crohn's disease on work or daily life functioning. (NCT00705614)
Timeframe: Up to 5 Years

Duration of Renal Response (Number of Days)

Duration in days until second occurrence of UPCR >0.5 mg/mg in those subjects who achieve a reduction in UPCR to below 0.5 mg/mg (NCT03021499)
Timeframe: Week 52

Time to 50% Reduction in UPCR (Number of Days)

Time in days to reduction in Urine Protein Creatinine Ratio to decrease by 50% compared to baseline. Baseline is the average of two pre-randomisation values. (NCT03021499)
Timeframe: 52 weeks

Time to Urine Protein Creatinine Ratio of ≤0.5 mg/mg (Number of Days)

Time in days to reduction in Urine Protein Creatinine Ratio to decrease to 0.5 mg/mg or less. (NCT03021499)
Timeframe: 52 Weeks

Change From Baseline in eGFR

Change from baseline by visit in estimated Glomerular Filtration rate. eGFR is corrected to a maximum value of 90 mL/min/1.73 m2 (NCT03021499)
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.

Change From Baseline in Patient Reported Outcomes

"Health-related quality of life (HRQoL) information was collected using the Short Form Health Survey (SF-36) HRQoL assessment and the LupusPRO (v1.7) assessment.~The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. Scoring ranges from 0 to 100 with higher scores reflecting better health.~LupusPro assessment is a patient-reported questionnaire regarding the effect of lupus or its treatment on the patient's health, quality of life, and the medical care received related to lupus. The questionnaire consists of 43 questions within 8 HRQOL domains and 4 Non-HRQoL domains. Scores range from 0 to 100 with higher scores reflecting better quality of life." (NCT03021499)
Timeframe: Week 24 and Week 52

Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA - SLEDAI)

"Change from baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score at Week 24 and 52.~The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity." (NCT03021499)
Timeframe: Week 24 and Week 52

Change From Baseline in UPCR

Change from baseline by visit in Urine Protein Creatinine Ratio. Baseline is the average of two pre-randomisation values. (NCT03021499)
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.

Number of Participants With Adjudicated Renal Response at Week 52

"The primary efficacy endpoint was the number of subjects showing renal response at Week 52. Renal response was adjudicated based on blinded data by an independent Clinical Endpoints Committee based on meeting the following criteria~UPCR of ≤0.5 mg/mg &~eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20% &~Received no rescue medication for LN &~Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during Weeks 44 through 52, prior to assessment Note:To be disqualified from renal response, the subject had to fail both eGFR measures (i.e., confirmed eGFR <60 mL/min/1.73 m2 & confirmed >20% drop from baseline) & have an associated treatment-related or disease-related AE that impacted eGFR Withdrawals prior to Week 52 with insufficient Week 52 data to determine response were defined non responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response" (NCT03021499)
Timeframe: 52 Weeks

Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less

Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less (NCT03021499)
Timeframe: 52 Weeks

Number of Participants With Renal Response at Week 24

"Number of subjects showing renal response at Week 24. Renal response was adjudicated based on blinded data by an Independent Clinical Endpoints Committee based on the following criteria:~UPCR of ≤0.5 mg/mg, & eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%, and Received no rescue medication for LN & Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during Weeks 16 through 24, just prior to the renal response assessment. Note:To be disqualified from renal response, the subject had to fail both eGFR measures (i.e., confirmed eGFR <60 mL/min/1.73 m2 AND confirmed >20% drop from BL) & have an associated treatment-related or disease-related AE that impacted eGFR. Subjects who withdrew prior to the Week 24 assessment and provided insufficient Week 24 data to determine response were defined as non-responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response." (NCT03021499)
Timeframe: Week 24

Number of Subjects Achieving 50% Reduction in Urine Protein Creatinine Ratio

Number of subjects achieving 50% reduction in Urine Protein Creatinine ratio (NCT03021499)
Timeframe: 52 Weeks

Number of Subjects Achieving, and Remaining in, Renal Response (Urine Protein Creatinine Ratio ≤0.5 mg/mg)

Number of subjects achieving, and remaining in, renal response (Urine Protein Creatinine ratio ≤0.5 mg/mg) (NCT03021499)
Timeframe: Week 52

Number of Subjects With Partial Renal Response at Weeks 24 & 52

Number of subjects with partial Renal Response (defined as a 50% reduction in UPCR from baseline) at Week 24 and at Week 52. Baseline UPCR is the average of 2 pre-randomisation values. (NCT03021499)
Timeframe: Weeks 24 and 52

Number of Subjects With Renal Response With Low Dose Steroids

Programmed Renal Response whilst on low dose steroids (<2.5 mg/day) for the preceding 8 Weeks at Weeks 24 and 52 (NCT03021499)
Timeframe: Week 24 and Week 52

Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Deaths

Treatment Failure was adjudicated by a clinical endpoints committee (CEC) and was defined as the time to the earliest occurrence of any one of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or a requirement for rescue therapy for exacerbation or deterioration of Lupus nephritis (LN). (NCT00377637)
Timeframe: From the start of the Maintenance Phase to Month 36

Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With End-stage Renal Disease (ESRD)

Time to treatment failure, adjudicated by the Clinical Endpoints Committee (CEC), was defined as any 1 the following: death, ESRD, sustained doubling of serum creatinine, renal flare (proteinuric or nephritic), or requirement for rescue therapy to treat deterioration or exacerbation of Lupus nephritis. ESRD is defined as progression to chronic hemodialysis or renal transplant. (NCT00377637)
Timeframe: From the start of the Maintenance Phase to Month 36

Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With Sustained Doubling of Serum Creatinine

Sustained doubling of serum creatinine concentration is defined as the first serum creatinine value that is twice the mean of the lowest 2 values from screening to end of induction, as confirmed by a second serum creatinine value obtained at least 4 weeks after the initial doubling. (NCT00377637)
Timeframe: From the start of the Maintenance Phase to Month 36

Maintenance Phase: Participants With Major Extra-renal Flare

A major extra-renal flare is defined as a British Isles Lupus Assessment Group (BILAG) Score category A in one extrarenal organ or three organs with concurrent category B scores. BILAG indices provide a scoring system for the assessment of lupus disease activity in terms of the need for steroid treatment in 8 organs/systems. Eighty-six items were scored resulting in a classification of A (severe activity), B (moderate activity), C (mild activity), D (no current activity) and E (no activity ever observed) for each organ system. (NCT00377637)
Timeframe: From the start of the Maintenance Phase to Month 36

Induction Phase: Change From Baseline in Short-Form Health Survey (SF-36) Domain and Component Scores

The SF-36 is a 36 item quality of life questionnaire. The short-form version has eleven questions that permit the participant to rate how they feel that particular day. The SF-36 consists of eight scaled scores and two component scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score with the higher scores indicating better quality of life. (NCT00377637)
Timeframe: Baseline and 24 weeks

Induction Phase: Change From Baseline to Week 24 in 24-hour Urine Protein

24-hour urine protein was measured at Baseline and Week 24. (NCT00377637)
Timeframe: Baseline, Week 24

Induction Phase: Change From Baseline to Week 24 in Serum Albumin

(NCT00377637)
Timeframe: Baseline, Week 24

Induction Phase: Change From Baseline to Week 24 in Serum Creatinine

(NCT00377637)
Timeframe: Baseline, Week 24

Induction Phase: Change in Renal British Isles Lupus Assessment Group (BILAG) Score

"BILAG indices provide a scoring system for the assessment of lupus disease activity in terms of the need for steroid treatment in 8 organs/systems. Eighty-six items were scored resulting in a classification of A (severe activity), B (moderate activity), C (mild activity), D (no current activity) and E (no activity ever observed) for each organ system. The BILAG individual system summaries were calculated by a program supplied by ADS-Limathon (Sheffield, UK).~The score at baseline was compared to the score at the 24 week endpoint for each treatment group, reported here for the renal system." (NCT00377637)
Timeframe: Baseline, 24 weeks

Induction Phase: Number of Participants Achieving Complete Remission

Number of participants achieving complete remission as defined by return to normal serum creatinine, proteinuria ≤500 mg/24 hours and an inactive urinary sediment (absence of red blood cells, white blood cells or cellular or granular casts) after 24 weeks. (NCT00377637)
Timeframe: 24 weeks

Induction Phase: Number of Patients Showing Treatment Response

Treatment response was adjudicated by a blinded clinical endpoints committee (CEC) and defined as: a) Decrease in proteinuria, defined as a decrease in the urine protein to creatinine ratio (UPCr) to <3 in subjects with baseline proteinuria ≥3 UPCr or a decrease in the UPCr by ≥50% in subjects with proteinuria <3 UPCr at Baseline, and b) Stabilization of serum creatinine or improvement. UPCr were derived from the 24 hour urine collection. Patients who did not show a treatment response at Week 24 or who withdrew earlier than Week 24 were considered non-responders. (NCT00377637)
Timeframe: 24 weeks

Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Not Receiving Rescue Therapy

The primary efficacy parameter was the time to treatment failure, adjudicated by the Clinical Endpoints Committee (CEC), defined as any of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or requirement for rescue therapy to treat deterioration or exacerbation of Lupus nephritis. Kaplan-Meier survival curves were estimated from the observed time to rescue treatment for each patient. The data presented are the percentage of participants who were rescue treatment free at each time interval as estimated by Kaplan-Meier. (NCT00377637)
Timeframe: From the start of the Maintenance Phase to Month 36

Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Renal Flare Free, by Time Interval

A proteinuric flare is defined as a doubling of the urine protein:creatinine ratio, and proteinuria ≥1 g/24 h in patients with urine protein ≤0.5 g/24 h at the end of the induction phase, or proteinuria ≥2 g/24 h if urine protein was >0.5 g/24 h at the end of the induction phase. A nephritic flare is defined as a 25% increase in serum creatinine accompanied by 1 or more of the following: (a) simultaneous doubling of the proteinuria reaching a minimum of 2 g/24 h (b) new/increased hematuria or (c) the appearance of cellular casts. All flares were adjudicated by a clinical endpoints committee. (NCT00377637)
Timeframe: From the start of the Maintenance Phase to Month 36

Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval

Treatment Failure was adjudicated by a clinical endpoints committee and was defined as the time to the earliest occurrence of any one of the following: death, end stage renal disease, sustained doubling of serum creatinine, renal flare, or a requirement for rescue therapy for exacerbation or deterioration of Lupus nephritis. Kaplan-Meier survival curves were estimated from the observed time to treatment failure for each patient. The data presented are the percentage of participants who were treatment-failure free at each time interval as estimated by Kaplan-Meier. (NCT00377637)
Timeframe: From the start of the Maintenance Phase to Month 36

Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments.

"Number (and percent) of adverse events experienced during the AURORA 2 treatment period.~To assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN." (NCT03597464)
Timeframe: Month 12 (AURORA 2 baseline) to Month 36

Change From AURORA 1 Baseline (i.e., Month 0) in Estimated Glomerular Filtration Rate (eGFR)

"Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2.~This endpoint incorporated Corrected eGFR values with a ceiling set to 90 mL/min/1.73 m^2~Increases in eGFR levels are indicative of better renal outcomes." (NCT03597464)
Timeframe: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Change From AURORA 1 Baseline (i.e., Month 0) in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)

"Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2.~Assessment of Systemic Lupus Erythematosus (SLE) Disease Activity within the last 10 days. It scores 24 disease descriptors across 9 organ systems which are summed to a minimum of <2 (considered indicative of no activity) and maximum of 105 points. Scores are weighted and a score of 6 is considered clinically significant. Higher scores indicate worse disease activity." (NCT03597464)
Timeframe: Months 18, 24 and 36

Change From AURORA 1 Baseline (i.e., Month 0) in Serum Creatinine (SCr)

"Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2.~Decreases in SCr levels can be indicative of better renal outcomes." (NCT03597464)
Timeframe: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein

"Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2.~Reductions in Urine Protein levels are indicative of better renal outcomes." (NCT03597464)
Timeframe: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein to Creatinine Ratio (UPCR)

"Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2.~Reductions in UPCR are indicative of better renal outcomes." (NCT03597464)
Timeframe: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Number (and Percent) of Subjects in Partial Renal Response

Partial renal response defined as a 50% reduction from baseline in urine protein creatinine ratio (UPCR). (NCT03597464)
Timeframe: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

Number (and Percent) of Subjects in Renal Response

"Proportion of subjects in renal response defined as:~urine protein creatinine ratio (UPCR) of ≤0.5 mg/mg~estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m^2 or no confirmed decrease from baseline in eGFR of >20%~Received no rescue medication for LN~Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during the 8 weeks prior to the renal response assessment." (NCT03597464)
Timeframe: Months 12 (AURORA 2 Baseline), 18, 24, 30 and 36

Duration of Complete Remission (Number of Weeks)

Duration of Complete Remission is defined as time of first occurrence of UPCR ≤ 0.5 mg/mg until the second increase above 0.5 mg/mg (i.e. a single occurrence above 0.5 is permitted) or use of rescue medication. (NCT02141672)
Timeframe: week 48

Number of Subjects Achieving Partial Remission

Partial remission is defined as a 50% reduction in UPCR from baseline at Week 24 and Week 48. (NCT02141672)
Timeframe: week 48

Number of Subjects Achieving Sustained Early Complete Remission

Sustained early complete remission defined as complete remission that occurred on or before Week 24 and was sustained through Week 48 (NCT02141672)
Timeframe: week 48

Number of Subjects Achieving Sustained Early Partial Remission

Early partial remission defined as partial remission that occurred on or before Week 24 and was sustained through Week 48 (NCT02141672)
Timeframe: week 48

Number of Subjects Achieving Sustained Partial Remission

Sustained partial remission defined as the first occurrence of partial remission that was sustained through Week 48 (NCT02141672)
Timeframe: week 48

Time to Complete Remission (Number of Weeks)

Time to Complete Remission is defined as time from first dose of voclosporin/placebo to UPCR ≤ 0.5mg in the absence of rescue medication. (NCT02141672)
Timeframe: week 48

Time to Partial Remission (Number of Weeks)

Time to partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction sustained until week 48 in the absence of rescue medication. (NCT02141672)
Timeframe: week 48

Time to Sustained Early Complete Remission (Number of Weeks)

Time to Sustained Complete Remission is defined as time from first dose of voclosporin/placebo to UPCR ≤ 0.5mg occurring at week 24 or earlier and sustained until week 48 in the absence of rescue medication. (NCT02141672)
Timeframe: week 48

Time to Sustained Early Partial Remission (Number of Weeks)

Time to sustained early partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction occurring at week 24 or earlier and sustained until week 48 in the absence of rescue medication. (NCT02141672)
Timeframe: week 48

Time to Sustained Partial Remission (Number of Weeks)

Time to sustained partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction sustained until week 48 in the absence of rescue medication. (NCT02141672)
Timeframe: week 48

Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Score

"The SELENA-SLEDAI assesses disease activity within the last 10 days. Twenty-four items are scored for nine organ systems, and summed to a maximum of 105 points. A score of 6 is considered clinically significant and indicates active disease. For analysis purposes, a score ≥6 was categorized as high. The 24 items are as follows: seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, and leukopenia." (NCT02141672)
Timeframe: Baseline, Week 24 and Week 48

Change From Baseline in UPCR at Weeks 24 and 48

Change from baseline in urine protein creatinine ratio at weeks 24 and 48 (NCT02141672)
Timeframe: Baseline, Week 24 and Week 48

Number of Subjects Achieving Complete Renal Remission at 24 and 48 Weeks in the Presence of Low Dose Steroids

"Complete remission is defined as:~Confirmed protein/creatinine ratio of ≤0.5 mg/mg and~eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or >10 mg prednisone for >3 consecutive days or >7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission.~Low-dose steroids is defined as use of ≤5 mg prednisone for 8 weeks leading up to the Week 24 visit date or for 12 weeks leading up to the Week 48 visit date." (NCT02141672)
Timeframe: Weeks 24 and 48

Number of Subjects Achieving Complete Renal Remission at 24 Weeks

"Complete remission is defined as:~Confirmed protein/creatinine ratio of ≤0.5 mg/mg and~eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or >10 mg prednisone for >3 consecutive days or >7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission." (NCT02141672)
Timeframe: week 24

Number of Subjects Achieving Complete Renal Remission at 48 Weeks

"Complete remission is defined as:~Confirmed protein/creatinine ratio of ≤0.5 mg/mg and~eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or >10 mg prednisone for >3 consecutive days or >7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission." (NCT02141672)
Timeframe: Week 48

Number of Subjects Achieving Partial Renal Remission at 24 and 48 Weeks

Number of patients with partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction at week 24 or week 48 in the absence of rescue medication. (NCT02141672)
Timeframe: week 24 and 48

Number of Subjects Achieving, and Remaining in, Complete Remission

Sustained complete remission defined as the first occurrence of complete remission that was sustained through Week 48 (NCT02141672)
Timeframe: week 48

The Rate of Allograft Rejection

(NCT00076570)
Timeframe: 3 years

The Rate of Significant Drug-associated Complications.

(NCT00076570)
Timeframe: 3 years

The Incidence of Biopsy-proven Acute Allograft Rejection During the First 12 Months of Transplant.

The incidence of rejection is determined by the proportion of patients experiencing biopsy proven acute allograft rejection during the first 12 months post-transplant. (NCT00166712)
Timeframe: Within 12 months post kidney transplant

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