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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Enalapril; Enalaprilat

Criteria

Inclusion Criteria:

• New adult renal transplant recipients with good renal function defined as serum creatinine less than 2.6 mg/dl,

• Normal serum potassium levels,

• No contraindication to ACE inhibitor use

Exclusion Criteria:

• Renal transplant patients with persistent serum creatinine levels over 2.5 mg/dl

• Hyperkalemia with serum potassium levels over 5.5 mEQ/dl

• History of allergic reaction to ACE inhibitors or angiotensin receptor blockers

• Pregnancy