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

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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
Boston, Massachusetts 02115
2578
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from 91732
Boston, MA
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Akron, Ohio 44314
2038
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Akron, OH
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Anderson, South Carolina 29621
2009
mi
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Anderson, SC
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Arvada, Colorado 80005
814
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Arvada, CO
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Ashland, Kentucky 41101
1981
mi
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Ashland, KY
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Atlantis, Florida 33462
2307
mi
from 91732
Atlantis, FL
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Auburn, Maine 04210
2615
mi
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Auburn, ME
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Bloomingdale, Illinois 60108
1707
mi
from 91732
Bloomingdale, IL
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Cedar Rapids, Iowa 52401
1527
mi
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Cedar Rapids, IA
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Cranston, Rhode Island 02920
2561
mi
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Cranston, RI
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Detroit, Michigan 48202
1965
mi
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Detroit, MI
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Los Angeles, California 90027
25
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Los Angeles, CA
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Pittsburgh, Pennsylvania 15212
2118
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Pittsburgh, PA
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Rochester, New York 14642
2242
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Rochester, NY
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