The Use of ACE Inhibitors in the Early Renal Post-transplant Period
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
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.