A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Evaluate The Efficacy And Safety Of Once-daily Administration Of A Chemokine Ccr2/5 Receptor Antagonist (Pf-04634817) In Adults With Type 2 Diabetes And Overt Nephropathy

CompletadoFase 2ClinicalTrials.gov

ID: NCT01712061Tipo: INTERVENTIONALInicio: 1 de dic de 2012Fin estimado: 1 de sept de 2014

Traducción no disponible, mostrando original

Resumen

The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a surrogate for improved glomerular filtration.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 CKD, based on an eGFR of 20-75 mL/min/1.73m2.
Evidence of persistent, overt albuminuria; defined as a UACR \>=300 mg/g (\>=33.9 mg/mmol) or UPCR \>=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer.
Stable background therapy of RAAS inhibition (ie, an ACE inhibitor and/or an ARB, which may also include an aldosterone antagonist in double RAAS but not triple RAAS inhibitor therapy) for at least 3 months before screening and to be maintained for the duration of the study.

Criterios de exclusión

Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD), severe peripheral vascular disease (PVD) or obstructive uropathy.

Intervenciones

drug

PF-04634817

Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function

drug

Placebo

Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function

Ubicaciones

Centro de Salud Renal Junin S.R.L.

Junín, Buenos Aires, Argentina

Centro de Investigaciones Medicas - Clinica de Fracturas y Ortopedia

Mar del Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Quilmes S.R.L

Quilmes, Buenos Aires, Argentina

Instituto de Cardiologia de Corrientes "Juana Francisca Cabral"

Corrientes, Argentina

CETENE S.A. - Centro de Nefrologia y Dialisis

San Miguel de Tucumán, Argentina

Centro de Investigaciones Clinicas del Litoral S.R.L.

Santa Fe, Argentina

Patrocinadores

PrincipalPfizer

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