losartan and Nephritis, Hereditary studies

Losartan: An antagonist of ANGIOTENSIN TYPE 1 RECEPTOR with antihypertensive activity due to the reduced pressor effect of ANGIOTENSIN II.
losartan : A biphenylyltetrazole where a 1,1'-biphenyl group is attached at the 5-position and has an additional trisubstituted imidazol-1-ylmethyl group at the 4'-position

Nephritis, Hereditary: A group of inherited conditions characterized initially by HEMATURIA and slowly progressing to RENAL INSUFFICIENCY. The most common form is the Alport syndrome (hereditary nephritis with HEARING LOSS) which is caused by mutations in genes for TYPE IV COLLAGEN and defective GLOMERULAR BASEMENT MEMBRANE.

Research Excerpts

Excerpt	Relevance	Reference
"A previous subgroup analysis of a 12-week, double-blind study demonstrated that losartan significantly lowered proteinuria versus placebo and amlodipine and was well tolerated in children (1-17 years old) with proteinuria secondary to Alport syndrome."	9.17	Losartan and enalapril are comparable in reducing proteinuria in children with Alport syndrome. ( Gleim, GW; Lam, C; Massaad, R; McCrary Sisk, C; Shahinfar, S; Webb, NJ; Wells, TG, 2013)
"Twelve weeks of treatment with losartan significantly reduced proteinuria compared with placebo/amlodipine: losartan -14."	9.15	Efficacy and safety of losartan in children with Alport syndrome--results from a subgroup analysis of a prospective, randomized, placebo- or amlodipine-controlled trial. ( Gleim, GW; Lam, C; Le Bailly De Tilleghem, C; Shahinfar, S; Strehlau, J; Webb, NJ; Wells, TG, 2011)
"A previous subgroup analysis of a 12-week, double-blind study demonstrated that losartan significantly lowered proteinuria versus placebo and amlodipine and was well tolerated in children (1-17 years old) with proteinuria secondary to Alport syndrome."	5.17	Losartan and enalapril are comparable in reducing proteinuria in children with Alport syndrome. ( Gleim, GW; Lam, C; Massaad, R; McCrary Sisk, C; Shahinfar, S; Webb, NJ; Wells, TG, 2013)
"Twelve weeks of treatment with losartan significantly reduced proteinuria compared with placebo/amlodipine: losartan -14."	5.15	Efficacy and safety of losartan in children with Alport syndrome--results from a subgroup analysis of a prospective, randomized, placebo- or amlodipine-controlled trial. ( Gleim, GW; Lam, C; Le Bailly De Tilleghem, C; Shahinfar, S; Strehlau, J; Webb, NJ; Wells, TG, 2011)

Research

Studies (2)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12

Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12

Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	2 (100.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Webb, NJ	2
Lam, C	2
Shahinfar, S	2
Strehlau, J	1
Wells, TG	2
Gleim, GW	2
Le Bailly De Tilleghem, C	1
Massaad, R	1
McCrary Sisk, C	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Randomized, Double-Blind, Parallel, Placebo or Amlodipine-Controlled Study of the Effects of Losartan on Proteinuria in Pediatric Patients With or Without Hypertension[NCT00568178]	Phase 3	306 participants (Actual)	Interventional	2007-06-01	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Intervention	mm Hg (Least Squares Mean)
Losartan-Hypertensive Participants	-3.8
Amlodipine-Hypertensive Participants	0.8

Intervention	mm Hg (Least Squares Mean)
Losartan-Hypertensive Participants	-5.5
Amlodipine-Hypertensive Participants	-0.1

"Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately twelve weeks of treatment.~Baseline is defined as values obtained at Visit 3, Week (-1) during the Single Blind Run-in period." (NCT00568178)
Timeframe: Baseline and Week 12

Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36

Intervention	Percent Change in Pr/Cr (Geometric Mean)
Losartan	-35.80
Amlodipine/Placebo	1.37

"The outcome measure of glomerular filtration rate was based on mL/min/1.73m^2, as determined by the Schwartz formula:~GFR = _____0.55 x height (cm)_______ divided by serum creatinine (mg/dL)~GFR values were compared to the baseline GFR measure.~[Note: For male participants, ages 13 to 17 years, 0.70 was used as~the multiplier in place of 0.55]~Baseline in regard to the extension is defined as the last value obtained in the double-blind treatment phase." (NCT00568178)
Timeframe: Baseline and Month 36

Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36

Intervention	Change in GFR mL/min1.73m^2 (Least Squares Mean)
Losartan Open Label Extension	3.3
Enalapril Open Label Extension	7.0

"Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately three years of treatment.~*The baseline for efficacy data in the extension was defined as the last value obtained in the double-blind treatment phase." (NCT00568178)
Timeframe: Baseline and Month 36

Intervention	Percent Change in Pr/Cr (Geometric Mean)
Losartan Open Label Extension	-30.01
Enalapril Open Label Extension	-40.45