The Use of ACE Inhibitors in the Early Renal Post-transplant Period
Information source: Montefiore Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Transplant Patients
Intervention: enalapril (Drug)
Phase: N/A
Status: Completed
Sponsored by: Montefiore Medical Center Official(s) and/or principal investigator(s): Maria Coco, MD, Principal Investigator, Affiliation: Montefiore Medical Center
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 >50% from baseline.
Clinical Details
Official title: The Use of ACE Inhibitors in the Early Renal Post-transplant Period
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: changes in serum creatinine and potassium
Secondary outcome: patient death, allograft loss
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 >50% 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
Eligibility
Minimum age: 21 Years.
Maximum age: 80 Years.
Gender(s): Both.
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, and no
contraindication to ACE inhibitor use.
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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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Locations and Contacts
Montefiore Medical Center, Bronx, New York 10467-2490, United States
Additional Information
Starting date: September 2004
Last updated: September 15, 2011
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