Study Evaluating The Effect Of Ramipril On Urinary Protein Excretion In Renal Transplant Patients Converted To Sirolimus

Completed · Phase 4 · Has a placebo group

Conditions studied: Kidney Transplant

In brief

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.

Key facts

Study ID: NCT00502242
Run by: Pfizer
People needed: 229
Starts: 2007-12-01
Expected to finish: 2013-09-01
Last updated by the study team: 2014-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Pfizer Investigational Site — Los Angeles, California, United States
Pfizer Investigational Site — Los Angeles, California, United States
Pfizer Investigational Site — San Francisco, California, United States
Pfizer Investigational Site — Aurora, Colorado, United States
Pfizer Investigational Site — Denver, Colorado, United States
Pfizer Investigational Site — Gainesville, Florida, United States
Pfizer Investigational Site — Chicago, Illinois, United States
Pfizer Investigational Site — Iowa City, Iowa, United States
Pfizer Investigational Site — Lexington, Kentucky, United States
Pfizer Investigational Site — Portland, Maine, United States
Pfizer Investigational Site — Boston, Massachusetts, United States
Pfizer Investigational Site — Springfield, Massachusetts, United States
Pfizer Investigational Site — Springfield, Massachusetts, United States
Pfizer Investigational Site — Gosse Pointe, Michigan, United States
Pfizer Investigational Site — Buffalo, New York, United States
Pfizer Investigational Site — Valhalla, New York, United States
Pfizer Investigational Site — Cleveland, Ohio, United States
Pfizer Investigational Site — Cleveland, Ohio, United States
Pfizer Investigational Site — Harrisburg, Pennsylvania, United States
Pfizer Investigational Site — Philadelphia, Pennsylvania, United States
Pfizer Investigational Site — Philadelphia, Pennsylvania, United States
Pfizer Investigational Site — Philadelphia, Pennsylvania, United States
Pfizer Investigational Site — Providence, Rhode Island, United States
Pfizer Investigational Site — Charleston, South Carolina, United States
Pfizer Investigational Site — Capital Federal, Buenos Aires, Argentina

Full record on ClinicalTrials.gov

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