NCT00270153

The Use of ACE Inhibitors in the Early Renal Post-transplant Period

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Chronic allograft nephropathy (CAN) is the leading cause of longterm renal transplant loss. Angiotensin-II may play a role in the development and progression of CAN. Angiotensin converting enzyme inhibitors (ACEI) comprise a drug class that inhibit the effects of angiotensin-II. However these drugs have been reported to cause elevated potassium and creatinine levels in some renal transplant patients. Yet, there are now several retrospective reports of long term benefits of improved renal function and graft survival in renal transplant recipients. There have been no reports of prospective randomized controlled trials of ACEI in renal transplant patients in the early post transplant period. The purpose of the present study is to assess the safety of enalapril, a drug in the ACEI class, when started 1-3 month post transplant. This is a double-blinded, randomized control trial of enalapril vs. placebo in new renal transplant patients with serum creatinine values no higher than 2.5mg/dl and normal serum potassium levels. The study drug will be administered for 6 months. Patients will be monitored in the renal transplant clinic every 1-4 weeks according to routine protocol. Clinical end-points will be occurence of potassium \>5.9mEQ/L or sustained increase in serum creatinine \>30% from baseline.

Detailed description

All new renal transplant recipients with functioning allografts and serum creatinine less than 2.6 mg/dl within the first 3 month post transplant would be eligible for this study of the safety of enalapril 5 mg vs placebo. Patients with serum potassium persistently over 5.5 mEQ/L would be excluded. This is a double-blinded randomized control study. End-points of the study are a persistent rise in serum creatinine of \>30% from baseline not otherwise explained by clinical evaluation, and persistent serum potassium \>5.9mEQ/L. Study duration is 6 month. At the end of the study patients will be continued on ACEI if clinically stable

Conditions

• Renal Transplant

Interventions

Type	Name	Description
DRUG	enalapril	5mg enalapril daily for 6 months
DRUG	Placebo	5mg enalapril-matching placebo daily for 6 months

Timeline

• Start date: 2004-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2005-12-26
• Last updated: 2019-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study