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

CompletadoFase 4ClinicalTrials.gov

ID: NCT00502242Tipo: INTERVENTIONALInicio: 1 de dic de 2007Fin estimado: 1 de sept de 2013

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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).

Intervenciones

drug

ramipril

Capsule - initial treatment is 5 mg (active)- oral - once per day

drug

ramipril

Capsule - initial treatment is 5 mg (placebo) - oral - once per day

Ubicaciones

Pfizer Investigational Site

Capital Federal, Buenos Aires, Argentina

Pfizer Investigational Site

San Martín, Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Córdoba, Argentina

Patrocinadores

PrincipalPfizer

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