CompletedPhase 3

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

306 participantsStarted 2007-06-01

Plain-language summary

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

Who can participate

Age range

12 Months – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Timeframe: Baseline and Month 36

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

Timeframe: Baseline and Month 36

Trial details

NCT IDNCT00568178

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-09-01

Results submitted2009-08-11

View on ClinicalTrials.gov More Proteinuria trials

Who can participate

Age range

12 Months – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

Timeframe: Baseline and Month 36

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

Timeframe: Baseline and Month 36