The Use of ACE Inhibitors in the Early Renal Post-transplant Period
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About
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.
Full 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
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
110 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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