An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2))

Phase 3

Completed

Interventions: Other: Placebo (Losartan)
Drug: Losartan Potassium
Drug: Enalapril Maleate

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Amlodipine Double-Blind Base Study (12-weeks)	Placebo (Losartan)	Hypertensive participants were randomized to receive either active losartan (plus amlodipine placebo) OR active amlodipine (plus losartan placebo) for 12 weeks.
Losartan Double-Blind Base Study (12-weeks)	Losartan Potassium	Normotensive participants received losartan. Hypertensive participants received either active losartan (plus amlodipine placebo) OR active amlodipine (plus losartan placebo).
Losartan Open-Label Extension Phase (Month 36)	Losartan Potassium	Participants were were carried over from the base study into the long-term safety extension. Participants in the extension were randomly assigned to either losartan or enalapril regardless of their previous randomized treatment. Dosing during the extension period (i.e. starting dose and any titration) was up to the investigator and varied by patient).
Enalapril Open-Label Extension Phase (Month 36)	Enalapril Maleate	Participants were were carried over from the base study into the long-term safety extension. Participants in the extension were randomly assigned to either losartan or enalapril regardless of their previous randomized treatment. Dosing during the extension period (i.e. starting dose and any titration) was up to the investigator and varied by patient).

Primary Outcome Measures

Name	Time	Method
Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36	Baseline and Month 36	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.
Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12	Baseline and Week 12	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.
Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36	Baseline and Month 36	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.

Secondary Outcome Measures

Name	Time	Method
Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12	Baseline and Week 12
Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12	Baseline and Week 12