Clinical trial NCT00270153: The Use of ACE Inhibitors in the Early Renal Post-transplant Period
Official title: The Use of ACE Inhibitors in the Early Renal Post-transplant Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Transplant
Keywords: renal transplant, ACE inhibitor
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2005-12-26
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 \>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

Eligibility 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

Primary outcomes:
measure: Changes in serum creatinine levels assessed at 6 months
timeFrame: Baseline and 6 months
measure: Changes in potassium levels assessed at 6 months
timeFrame: Baseline and 6 months
measure: Decrease in estimated glomerular filtration rate (eGFR) assessed at 6 months
timeFrame: Baseline and 6 months.
Secondary outcomes:
measure: Cough due to drug intolerance assessed at 6 months
timeFrame: Baseline and 6 months
measure: abdominal pain due to drug intolerance assessed at 6 months
timeFrame: Baseline and 6 months
measure: Erythrocytosis assessed at 6 months
timeFrame: Baseline and 6 months
measure: Leukopenia assessed at 6 months
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Maria Coco, MD
role: PRINCIPAL_INVESTIGATOR
References: