NCT01485978

Efficacy and Safety Study to Delay Renal Failure in Children With Alport Syndrome

Early Prospective Therapy Trial to Delay Renal Failure in Children With Alport Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH · Academic / Other
• Sex: All
• Age: 24 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, multi-centre, randomised, placebo-controlled, patient and investigator-blind study in paediatric patients with early stages of Alport syndrome to assess the safety and efficacy of the ACEi ramipril in slowing disease progression. Alport syndrome stages that describe the extent of renal damage and loss of function are defined as: * 0 Microhaematuria without microalbuminuria (usually at birth) * I Microalbuminuria (30-300 mg albumin/gCrea) * II Proteinuria \>300 mg albumin/gCrea * III \> 25% decline of normal renal function (creatinine clearance) * IV End stage renal failure (ESRF) Eligible patients with Alport stages 0 and I will be randomly assigned at a 2:1 ratio to receive once daily ramipril or placebo. In addition, Alport stage II patients may be treated open Label. Eligible patients who, or whose parents/legal guardian refuse randomisation after eligibility is confirmed, and patients who have been treated with ramipril prior to the study, may be treated open-label with ramipril as per protocol. The total number of patients will not exceed 120, with the number of randomised patients not exceeding 60, and the number of patients treated open label from Day 1 of the study aimed to be approximately 60. Randomised patients whose disease progresses to the next disease level during the 3 year treatment period will be unblinded, and open label ramipril treatment will be initiated and continued, respectively, depending on prior treatment randomisation.

Conditions

• Renal Insufficiency, Chronic

Interventions

Type	Name	Description
DRUG	Ramipril	Ramipril (Delix) tablets containing 2.5 mg ramipril, oral application with 1 to 6 mg per body surface area ramipril once daily for 3 years.
DRUG	placebo to ramipril	Oral application of placebo to ramipril, once daily with 1 to 6 mg per body surface area for 3 years or until disease progression.
DRUG	Ramipril	Oral treatment with 1 to 6 mg per body surface area ramipril once daily for 3 years as per protocol.

Timeline

• Start date: 2012-03-01
• Primary completion: 2018-09-01
• Completion: 2019-03-01
• First posted: 2011-12-06
• Last updated: 2020-06-17

Locations

1 site across 1 country: Germany