Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)

CompletadoFase 3ClinicalTrials.gov

ID: NCT00114777Tipo: INTERVENTIONALInicio: 1 de feb de 2005Fin estimado: 1 de sept de 2014

Traducción no disponible, mostrando original

Resumen

The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Subject is a first-time recipient of a kidney transplant from a deceased donor.
Specific donor criteria

Criterios de exclusión

Donor age \<10 years
Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.)
Subjects with a positive T-cell lymphocytotoxic crossmatch.
Subjects who are positive for Hepatitis B or C, or HIV
Active tuberculosis
History of cancer in the last 5 years
History of substance abuse
Specific laboratory results are exclusionary
Mammography suspicious for cancer
Allergy to iodine
For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)

Intervenciones

drug

Cyclosporin A

tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months, 100-250 ng/mL, daily, 84 months

drug

Belatacept Less Intensive Regimen (LI)

solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months

drug

Belatacept More Intensive Regimen (MI)

solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months

Ubicaciones

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Cordoba, Crd, Córdoba Province, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Local Institution

Santa Fe, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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