ISRCTN78129473
Completed
未知
Angiotensin Converting Enzyme (ACE) inhibition for the preservation of renal function and patient survival in kidney transplantation: a randomised, double blind, placebo-controlled trial
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute0 sites528 target enrollmentJuly 13, 2006
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Chronic kidney disease in renal transplant patients
- Sponsor
- Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
- Enrollment
- 528
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 16/07/2008:
- •Patients, either sex, who underwent the kidney transplantation and who:
- •1\. Have an estimated glomerular filtration rate greater than or equal to 20 ml/min/1\.73 m^2 using the Modification of Diet in Renal Disease study (MDRD) equation which has been validated in renal transplant patients
- •2\. Have proteinuria \= 0\.2 grams/day
- •3\. Are at least three months post\-transplantation
- •4\. Have signed informed consent
- •Previous inclusion criteria:
- •Patients, either sex, who underwent the kidney transplantation and who:
- •1\. Have an estimated glomerular filtration rate between 20 and 55 ml/min using the Modification of Diet in Renal Disease study (MDRD) equation which has been validated in renal transplant patients
- •2\. Have proteinuria \= 0\.2 grams/day
Exclusion Criteria
- •1\. Unable to provide informed consent
- •2\. Less than 18 years old
- •3\. Pregnant (ramipril contraindicated)
- •4\. Angioedema from an ACE inhibitor or angiotensin receptor blocker or other known reaction to an ACE inhibitor (such as rash, neutropenia or cough)
- •5\. Serum potassium greater than 5\.5 mmol/l on two or more occasions in the preceding three months for those not on an ACE inhibitor or angiotensin receptor blocker
- •6\. Serum potassium greater than 5\.9 mmol/l on two or more occasions in the preceding three months for those on an ACE inhibitor or angiotensin receptor blocker
- •7\. Left ventricular dysfunction that requires an ACE inhibitor or an angiotensin receptor blocker
- •8\. Other severe co\-morbid conditions (e.g. malignancy, disabling stroke) with life expectancy less than three months
- •9\. New immunosuppressive agent was started or previous immunosuppressant stopped in the three months prior to study entry or plan to switch immunosuppressive agents within next three months
- •10\. Had an acute coronary syndrome, stroke or transient ischaemic attack in the three months prior to study entry
Outcomes
Primary Outcomes
Not specified
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