Renal Transplant Clinical Trial
Official title:
The Use of ACE Inhibitors in the Early Renal Post-transplant Period
Verified date | February 2019 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in serum creatinine levels assessed at 6 months | Creatinine is a waste product that comes from the normal wear and tear on muscles of the body. It is excreted through the kidneys. High serum creatinine levels in the blood indicate that the kidneys aren't functioning properly. Increase in serum creatinine of 30% would be a safety concern and requires clinical management. | Baseline and 6 months | |
Primary | Changes in potassium levels assessed at 6 months | Potassium is a chemical that is critical to the function of nerve and muscle cells, including those in your heart. Potassium levels must be kept within a very narrow concentration range. High Potassium levels are a sign of worsening kidney function. An occurence of serum potassium greater than 5.9 mEq/L is a safety concern and requires clinical management. | Baseline and 6 months | |
Primary | Decrease in estimated glomerular filtration rate (eGFR) assessed at 6 months | eGFR is a number based on your blood test for creatinine, a waste product in your blood.It tells how well your kidneys are working. A normal eGFR is 60 or more. A 25 percent decrease in eGFR indicates that the kidneys may not be working well. This is a safety concern and requires clinical management. | Baseline and 6 months. | |
Secondary | Cough due to drug intolerance assessed at 6 months | Cough experienced because of inability to tolerate the adverse effects of the medication | Baseline and 6 months | |
Secondary | abdominal pain due to drug intolerance assessed at 6 months | Abdominal pain experienced because of inability to tolerate the adverse effects of the medication | Baseline and 6 months | |
Secondary | Erythrocytosis assessed at 6 months | Erythrocytosis is a condition in which your body makes too many red blood cells (RBCs). Too many red blood cells can make your blood thicker than normal and lead to blood clots and other complications. | Baseline and 6 months | |
Secondary | Leukopenia assessed at 6 months | Leukopenia is a decrease in the number of white blood cells found in the blood, which places individuals at increased risk of infection. | Baseline and 6 months |
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