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

Proteinuria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00568178
• Other study ID #: 0954-326
• Secondary ID: 2006-006415-74
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2007
• Est. completion date: March 1, 2011

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: March 1, 2011
• Est. primary completion date: September 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 17 Years

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)

Related Conditions & MeSH terms

• Proteinuria

Intervention

Drug:
• Losartan Potassium
Losartan Use During the Double-Blind Treatment Phase: Losartan potassium was administered orally as tablets; 25 or 50 milligrams (mg); or as a liquid suspension 2.5 mg/mL prepared for participants who weighed less than 25 kilograms (kg) or for those participants unable to swallow tablets. During the double-blind period, participants were initially randomized to either a once-daily weight-dependent dose of approximately 0.7 mg/kg (25 mg tablet; up to 50 mg per day) and at 2-weeks the dose was increased to a once-daily maximum weight-dependent dose of 1.4 mg/kg. The maximum dose of losartan, as specified in the protocol, was 50 mg/day (if the patient weighed <50 kg) or 100 mg/day (if the patient weighed =50 kg). Losartan Use During the Treatment Extension Phase: Dose modifications of the drug were left up to the discretion of the Investigators based on each participant's level of tolerance.

Other:
• Comparator: Placebo (Losartan)
Placebo (losartan suspension), administered orally, once daily for 12 weeks

Drug:
• Comparator: amlodipine besylate
Amlodipine besylate (1 mg/mL) liquid suspension, oral administration, titrated to 0.2 mg/kg/day (5 mg maximum dose) per day for 12 Weeks

Other:
• Comparator: Placebo (amlodipine besylate)
Liquid suspension, 1mg/mL, titrated to 0.2 mg/kg/day (5 mg maximum dose) once daily, for 12 weeks
• Placebo (Losartan)
Normotensive patients randomized to losartan placebo for 12 weeks.

Drug:
• Enalapril Maleate
Enalapril 2.5-, 5-, 10-, and 20-mg tablets or enalapril suspension (1 mg/mL), oral administration, once daily for 36 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at 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.	Baseline and Week 12
Primary	Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at 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.	Baseline and Month 36
Primary	Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at 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.	Baseline and Month 36
Secondary	Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12		Baseline and Week 12
Secondary	Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12		Baseline and Week 12