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

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Los Angeles, California, 90033-4612 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Transplant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects who are currently receiving, or have received within 4 weeks before
enrollment, RAAS blockade.

- Subjects with a calculated GFR 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.

NCT00502242
Pfizer
Completed
Study Evaluating The Effect Of Ramipril On Urinary Protein Excretion In Renal Transplant Patients Converted To Sirolimus

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