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Belatacept to Prevent Organ Rejection in Kidney Transplant Patients (BESTT)

23 de marzo de 2017 actualizado por: National Institute of Allergy and Infectious Diseases (NIAID)

The Safety and Efficacy of Belatacept, Antithymocyte Globulin, and Sirolimus in Recipients of Non-HLA-identical Living-donor Renal Transplants (ITN023ST)

Belatacept is an experimental medication shown in clinical trials to have immune system suppression properties in people who have had renal (e.g., kidney) transplants. This study will determine whether a combination of anti-rejection drugs, including belatacept, can prevent the rejection of a first-time, non-human leukocyte antigen (HLA) identical renal transplant and allow patients to be safely withdrawn from anti-rejection therapy one year post-transplant.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Drugs that suppress the immune system have contributed to increased success of transplantation; however, to prevent organ rejection, transplant recipients need to take immunosuppressive drugs for the rest of their lives. These drugs make patients more susceptible to infection and certain kinds of cancer. Belatacept is an experimental medication that specifically targets immune reactions against transplanted organs and has been shown to be effective in preventing kidney transplant rejection in previous clinical trials. Both thymoglobulin, an antibody, and sirolimus, an anti-rejection drug, prevent rejection by lowering the response of the immune system to the transplanted organ. This study will evaluate whether belatacept, along with thymoglobulin and sirolimus, is safe in kidney transplant patients. The study will also evaluate this regimen's potential to allow tapering and eventual discontinuation of all immunosuppressive drugs.

This study will last up to 4 years. At the time of transplant, participants will begin an immunosuppressive treatment regimen consisting of thymoglobulin, sirolimus, and belatacept. Participants will receive infusions of thymoglobulin on days 1 through 4, and a combination of oral sirolimus (daily) and belatacept infusions at day 5, then weeks 2, 4, 8, and monthly for at least 2 years. Dose reduction of belatacept will occur at 12 weeks post-transplant. At Year 2, eligible participants may choose to begin drug withdrawal or continue study therapy through the end of the study. Study visits will occur weekly for the first two months, then monthly. These visits will include belatacept treatment, general medical assessments, blood and urine collection, and other assessments to determine overall health of the recipient's immune system and kidney transplant and to better understand the way the immune system works in the acceptance or rejection of organ transplants.

*** IMPORTANT NOTICE: *** The National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network do not recommend the discontinuation of immunosuppressive therapy for recipients of cell, organ, or tissue transplants outside of physician-directed, controlled clinical studies. Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances, upon the recommendation and with the guidance of your health care provider.

Tipo de estudio

Intervencionista

Inscripción (Actual)

5

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • San Francisco, California, Estados Unidos, 94143
        • University of California, San Francisco
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Emory University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Receiving first renal (e.g., kidney) transplant
  • Transplant is from a non-HLA-identical living donor
  • Willing to use acceptable forms of contraception

Exclusion Criteria:

  • Positive for anti-human globulin (AHG) or T-cell cross-match with the donor
  • Receiving multiple-organ transplant
  • History of cancer within the 5 years prior to study entry. Patients who have certain nonmelanoma skin cancers are not excluded
  • Human immunodeficiency virus (HIV) infected
  • Hepatitis B (HBV) or C (HCV) virus infected
  • Other active infections
  • Active tuberculosis (TB) infection within the 3 years prior to study entry
  • Pregnancy or breastfeeding

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Belatacept
Immunosuppressive protocol consisting of belatacept, glucocorticoids, antithymocyte globulin (ATG), and sirolimus.
Droga: Belatacept
10 mg/kg given intravenously (IV) on transplant (day 1), day 5, and at weeks 2, 4, 8 and 12, then 5 mg/kg IV every 4 weeks
Otros nombres:
  • Nulojix
  • LEA29Y
Droga: Sirolimus
4 mg/day (oral tablet) at transplant (day 1), then dose adjusted to maintain serum trough level of 8-12 ng/mL for at least 1 year
Otros nombres:
  • Rapamicina
  • Rapamune
Droga: Anti-thymocyte globulin
1.5 mg/kg given IV daily on days 1 through 4. Subjects are premedicated with glucocorticoids, acetaminophen 650 mg by mouth, and diphenhydramine 25- 50 mg by mouth prior to each dose.
Otros nombres:
  • ATG
  • Thymoglobulin®
  • inmunoglobulina antitimocito
Droga: methylprednisolone
500 mg given IV at transplant (day 1), then given 250 mg IV on day 2 and given 0.5 mg/kg IV or prednisone 0.5 mg/kg given by mouth on days 3 and 4
Otros nombres:
  • Medrol
  • glucocorticoide

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Acute Rejection at 6-Months
Periodo de tiempo: 6 months post-transplant

Cumulative incidence of acute rejection[1] at 6 months post-transplant based on local pathology biopsy reads

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
6 months post-transplant

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Participant Survival at 12 Months Post-Transplant
Periodo de tiempo: 12 months post-transplant
12 months post-transplant
Acute Rejection at 12-Months
Periodo de tiempo: 12 months post-transplant

Incidence of acute rejection[1] at 12 months post-transplant

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
12 months post-transplant
Tolerance Induction
Periodo de tiempo: 48 months
Time from transplantation to initiation of sirolimus withdrawal.
48 months
Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks
Periodo de tiempo: 24 weeks post-transplant

GFR utilizing clearance of iothalamate.

GFR is an index of level of kidney function. A higher value means better kidney function.
24 weeks post-transplant
Graft Survival at 12 Months Post-transplant
Periodo de tiempo: 12 months post-transplant
12 months post-transplant
Time From Transplant to Acute Rejection
Periodo de tiempo: Transplantation until rejection occurs (participants followed up to four years post-transplantation)

Time (days) from transplant to occurrence of acute rejection[1]

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Transplantation until rejection occurs (participants followed up to four years post-transplantation)
Proportion of Participants Requiring Antilymphocyte Therapy for Acute Rejection
Periodo de tiempo: Participants followed from transplantation until completion of study (up to four years post-transplantation)

Proportion of participants who experienced acute rejection[1] requiring antilymphocyte therapy

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With Post-transplant Infections
Periodo de tiempo: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of participants who experienced infections post-transplant. Participants were checked for any type of opportunistic infection at all study visits post-transplantation (up to 4 years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With Wound Complications
Periodo de tiempo: Start of study to end of study
Start of study to end of study
Proportion of Participants With Malignancies
Periodo de tiempo: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With a Sirolimus Associated Adverse Event
Periodo de tiempo: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With Chronic Allograft Nephropathy
Periodo de tiempo: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With Delayed Graft Function
Periodo de tiempo: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)
Proportion of Participants With Post-transplant Diabetes Mellitus
Periodo de tiempo: Participants followed from transplantation until completion of study (up to four years post-transplantation)
Participants followed from transplantation until completion of study (up to four years post-transplantation)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

National Institute of Allergy and Infectious Diseases (NIAID)

Colaboradores

Immune Tolerance Network (ITN)

Investigadores

  • Investigador principal: Flavio Vincenti, MD, University of California, San Francisco
  • Investigador principal: Christian Larsen, MD, Emory University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de diciembre de 2006

Finalización primaria (Actual)

1 de febrero de 2010

Finalización del estudio (Actual)

1 de febrero de 2010

Fechas de registro del estudio

Enviado por primera vez

27 de junio de 2006

Primero enviado que cumplió con los criterios de control de calidad

27 de junio de 2006

Publicado por primera vez (Estimar)

29 de junio de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de abril de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

23 de marzo de 2017

Última verificación

1 de marzo de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • DAIT ITN023ST

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Data access is provided to the public in Participant level data and additional relevant materials are available to the public in : 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools available to researchers; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal that makes data from the consortium's clinical trials publicly available.

Datos del estudio/Documentos

  1. Conjunto de datos de participantes individuales
    Identificador de información: SDY674
    Comentarios de información: ImmPort study identifier is SDY674
  2. Protocolo de estudio
    Identificador de información: SDY674
    Comentarios de información: ImmPort study identifier is SDY674. The study protocol is available in the Design tab section.
  3. Study summary, -design, -synopsis,- medications, -demographics, -lab tests, -files
    Identificador de información: SDY674
    Comentarios de información: ImmPort study identifier is SDY674
  4. Conjunto de datos de participantes individuales
    Identificador de información: ITN023ST
    Comentarios de información: TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available.
  5. Protocol synopsis, -data and reports, -specimens availability
    Identificador de información: ITN023ST
    Comentarios de información: TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available.

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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