Study Evaluating The Effect Of Ramipril On Urinary Protein Excretion In Renal Transplant Patients Converted To Sirolimus
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/19/2013 |
Start Date: | December 2007 |
End Date: | September 2013 |
Contact: | Pfizer CT.gov Call Center |
Phone: | 1-800-718-1021 |
A Randomized, Placebo Controlled, Double-Blind Comparative Study Evaluating The Effect of Ramipril On Urinary Protein Excretion In Maintenance Renal Transplant Patients Converted To Sirolimus
The primary objective of the study is to determine the efficacy of ramipril in preventing a
urinary protein to creatinine ratio (U p/c) greater than 0.5 following conversion to
sirolimus from a calcineurin inhibitor (CNI) in maintenance kidney transplant patients.
Inclusion Criteria:
- Receiving cyclosporine (CsA) or tacrolimus (TAC) since the first month
post-transplant.
- In addition to a calcineurin inhibitor (CNI), subjects must be treated with either
corticosteroids at a dosage range of 2.5 to 15 mg/day for prednisone or prednisolone
(2 to 12mg/day for methylprednisolone or the alternate day equivalent) or a
steroid-free regimen for a minimum of 12 weeks before randomization or either MMF
(>/=500mg/day), mycophenolate sodium (MPS) (>/=360 mg/day) or AZA (>/=50mg/day).
Subjects must be taking a minimum of 2 immunosuppressive drugs if on a steroid-free
regimen.
- Subject is 3 to 60 months after renal transplantation.
- Subject is greater than 12 weeks after treatment for any acute rejection.
Exclusion Criteria:
- Subjects who are currently receiving, or have received within 4 weeks before
enrollment, RAAS blockade.
- Subjects with a calculated GFR < 40mL/min (per the Modification of Diet in Renal
Disease [MDRD-7] or abbreviated MDRD formula).
- Subjects with a urine protein to creatinine ratio (U p/c) of >0.3.
- Subjects with a history of uncontrolled systolic blood pressure (SBP >140 mm Hg).
- Subjects with severe hepatic impairment (Grade C Child-Pugh score). Additional
Inclusion / Exclusion Criteria apply.
We found this trial at
14
sites
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