Phase 3
Completed N=306
An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2))
Proteinuria
Source: ClinicalTrials.gov NCT00568178 ↗
Enrolled (actual)
306
Serious AEs
11.3%
Results posted
Oct 2009
Primary outcomePrimary: Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12 — -35.80; 1.37 Percent Change in Pr/Cr — p=0.001
Summary
The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12 |
-35.80; 1.37 | 0.001 sig |
| PRIMARY Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36 |
-30.01; -40.45 | — |
| PRIMARY Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36 |
3.3; 7.0 | — |
| SECONDARY Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12 |
-5.5; -0.1 | — |
| SECONDARY Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12 |
-3.8; 0.8 | — |
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)
Data sourced from ClinicalTrials.gov (NCT00568178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.