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Completed

NCT Number: NCT00568178

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

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

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Key information

Conditions

Proteinuria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

12 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Losartan Potassium

Drug

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 names: Cozaar®

Comparator: Placebo (Losartan)

Other

Placebo (losartan suspension), administered orally, once daily for 12 weeks

Comparator: amlodipine besylate

Drug

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 names: NORVASC®

Comparator: Placebo (amlodipine besylate)

Other

Liquid suspension, 1mg/mL, titrated to 0.2 mg/kg/day (5 mg maximum dose) once daily, for 12 weeks

Other names: NORVASC®

Placebo (Losartan)

Other

Normotensive patients randomized to losartan placebo for 12 weeks.

enalapril maleate

Drug

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

Other names: Vasotec®, Renitec®

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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 outcomes

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

    Time frame: Baseline and Week 12

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

    Time frame: Baseline and Week 12

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2011
First posted
Dec 5, 2007
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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