Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based Immunosuppression

CompletadoFase 3ClinicalTrials.gov

ID: NCT01820572Tipo: INTERVENTIONALInicio: 27 de mar de 2013Fin estimado: 24 de oct de 2019

Traducción no disponible, mostrando original

Resumen

The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Men and women, ages 18-75 inclusive
Adult recipients of a renal allograft from a living donor or a deceased donor between 6-60 months prior to enrollment
Receiving a stable (≥1 month) regimen of Calcineurin inhibitor (CNI) \[Cyclosporine A (CsA) or Tacrolimus (TAC)\] with Mycophenolate mofetil (MMF) or Enteric Coated Mycophenolate Sodium (EC-MPS)/Mycophenolic acid (MPA), and corticosteroids
Stable renal function for 12 weeks prior to enrollment without new onset proteinuria
Calculated glomerular filtration rate (cGFR) ≥30 and ≤75 mL/min/1.73 m2 \[Modification of Diet in Renal Disease study (MDRD) 4-formula\]

Criterios de exclusión

Recipients with Epstein-Barr virus (EBV) serostatus negative or unknown
History of acute rejection (AR) within 3 months prior to enrollment
History of antibody mediated rejection
Positive T-cell lymphocytotoxic cross match
Proteinuria \>1 g/day or \>0.5 g/day if diabetic

Intervenciones

drug

Belatacept

drug

Tacrolimus

drug

Cyclosporine

Ubicaciones

Local Institution

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution

Mendoza, Buenos Aires, Argentina

Local Institution

Cardoba, Córdoba Province, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Local Institution

Buenos Aires, Argentina

Local Institution

CABA, Argentina

Local Institution

Córdoba, Argentina

Local Institution

Santa Fe, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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