Treatment of proteinuria with angiotensin-converting enzyme inhibitor in children after renal transplantatio

Phase 1

• Conditions: proteinuria and hypertension; MedDRA version: 9.1Level: LLTClassification code 10037032Term: Proteinuria

• Registration Number: EUCTR2006-006867-22-CZ
• Lead Sponsor: niversity Hospital Motol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-19
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients up to 18 years at least 6 months after renal transplantation with functional graft and persistent proteinuria >200mg/m2/day (on 2 consecutive occasions at least 1 month apart) not being treated with ACE-inhibitors.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

stenosis of graft artery, acute rejection < 3 months before study entry, severe chronic allograft nephropathy with severely reduced glomerular filtration rate (estimated creatinine clearance <30 ml/min/1.73m2), patients with hypotension, patients with a history of allergic or other adverse effects of ACE-inhibitors, pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified