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

Pfizer

Status and phase

Completed

Phase 4

Conditions

Kidney Transplant

Treatments

Drug: ramipril

Study type

Interventional

Funder types

Industry

Identifiers

NCT00502242

B1741001

0468E5-4439

Details and patient eligibility

About

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.

Enrollment

229 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.