Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270153
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2005-12-23
Brief Title:
The Use of ACE Inhibitors in the Early Renal Post-transplant Period
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
The Use of ACE Inhibitors in the Early Renal Post-transplant Period
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 25mgdl 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 59mEQL or sustained increase in serum creatinine 30 from baseline
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 25mgdl 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 59mEQL or sustained increase in serum creatinine 30 from baseline
Detailed Description:
All new renal transplant recipients with functioning allografts and serum creatinine less than 26 mgdl 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 55 mEQL 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 59mEQL Study duration is 6 month At the end of the study patients will be continued on ACEI if clinically stable
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None