The Use of ACE Inhibitors in the Early Renal Post-transplant Period
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 2/9/2019 |
| Start Date: | September 2004 |
| End Date: | December 2009 |
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.
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.
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
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
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
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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