Clinical trial NCT00568178: An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2))
Official title: A Randomized, Double-Blind, Parallel, Placebo or Amlodipine-Controlled Study of the Effects of Losartan on Proteinuria in Pediatric Patients With or Without Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Proteinuria
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 306
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric patients.

Detailed description: The study included a 12-week double-blind treatment phase and a 36-month open-label extension phase. Participants who completed or discontinued the initial 12-week phase of the study and who opted to participate in the open label extension phase were randomized to either losartan or enalapril at a dose of the investigator's choosing for the duration of the extension. The open label extension was designed to continue until the 100th participant completed 3 years of follow-up.

Eligibility criteria: Inclusion Criteria:

* Participant is 1 to 17 years of age
* Able to provide a first-morning urine sample each day during the study
* Documented history of proteinuria associated with chronic kidney disease of any origin
* Signed consent of parent and/or legal guardian

Exclusion Criteria:

* Pregnant and/or nursing
* Requires more than 2 medications to control high blood pressure
* Has undergone major organ transplantation (e.g. heart, kidney, liver)
* Known sensitivity to losartan or other similar drugs, or any history of angioneurotic edema
* Known sensitivity to amlodipine or other calcium channel blocker
* Requires cyclosporine to treat renal disease (kidney disease)

Primary outcomes:
measure: Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12
timeFrame: Baseline and Week 12
measure: Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36
timeFrame: Baseline and Month 36
measure: Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36
timeFrame: Baseline and Month 36
Secondary outcomes:
measure: Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12
timeFrame: Baseline and Week 12
measure: Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Webb NJ, Shahinfar S, Wells TG, Massaad R, Gleim GW, McCrary Sisk C, Lam C. Losartan and enalapril are comparable in reducing proteinuria in children with Alport syndrome. Pediatr Nephrol. 2013 May;28(5):737-43. doi: 10.1007/s00467-012-2372-9. Epub 2012 Dec 4.
citation: Webb NJ, Shahinfar S, Wells TG, Massaad R, Gleim GW, Santoro EP, Sisk CM, Lam C. Losartan and enalapril are comparable in reducing proteinuria in children. Kidney Int. 2012 Oct;82(7):819-26. doi: 10.1038/ki.2012.210. Epub 2012 Jun 27.
citation: Webb NJ, Lam C, Shahinfar S, Strehlau J, Wells TG, Gleim GW, Le Bailly De Tilleghem C. Efficacy and safety of losartan in children with Alport syndrome--results from a subgroup analysis of a prospective, randomized, placebo- or amlodipine-controlled trial. Nephrol Dial Transplant. 2011 Aug;26(8):2521-6. doi: 10.1093/ndt/gfq797. Epub 2011 Feb 1.