- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00240994
Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients
A Phase II Exploratory Study to Determine the Safety and Study the Immunomodulatory Functions of Induction Therapy With Campath, Combined With Chronic Immunosuppression With Mycophenolate Mofetil and Sirolimus
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Kidney transplantation is widely considered to be the treatment of choice for children with End Stage Renal Disease (ESRD). Improvements in surgical techniques, donor selection, and immunosuppression practices, as well as the enhanced experience of specialized pediatric transplant teams, have all led to marked improvements in patient and kidney graft survival in infants and young children ages 1 to 10. However, young children now have more infections following transplant previously. Also, improved graft survival is not observed in pediatric renal transplant recipients 11 to 17 years of age. Some studies do indicate that the poor long term outcome of patient and kidney survival observed in this age group may be caused by noncompliance with immunosuppressive medications. Therefore, protocols that minimize the use of immunosuppressive medications while retaining kidney function are necessary for improving graft and patient survival in children. This study will evaluate the safety of a regimen containing alemtuzumab after kidney transplantation, followed by steroid avoidance and calcineurin inhibitor withdrawal in pediatric renal transplant recipients 1 to 20 years of age.
The accrual period is scheduled for 18 months. The study follow-up period will last 24 months. All participants enrolled will undergo this treatment schedule: 1.) All participants will receive intravenous alemtuzumab one day before transplantation and 1 day after transplantation. 2.) Mycophenolate mofetil (MMF) will be administered orally no later than 2 days after transplantation. 3.) Participants will begin to take oral tacrolimus twice a day 1 to 3 days after transplantation until Weeks 8 through 12 when 4.) Sirolimus will be initiated. 5.) Sirolimus and MMF will be taken orally until Month 24.
Blood collection will occur at baseline, 1 day before transplant, at Days 1 and 3, at Weeks 2, 4, 6, 8, 10, and at Months 3 through 24. Scheduled kidney (renal) biopsies will be performed at transplant, during Weeks 8 through 12, immediately before conversion to sirolimus, and at Months 6 and 24.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
San Francisco, California, Estados Unidos, 94143-0116
- University of California, San Francisco
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02115
- Children's Hospital, Boston
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hospital, Philadelphia
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98105
- Children's Hospital and Regional Medical Center, Seattle
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Between the ages of 1 to 20 (prior to 21st birthday)
- End Stage Renal Disease
- Necessity of kidney transplant
- First kidney transplant received from a living donor
- A living kidney donor identified
- No known contraindications to therapy with alemtuzumab
- Negative pregnancy test before study entry
- Willing to use approved methods of contraception for the duration of the study, 6 weeks after discontinuation of MMF, and 12 weeks after discontinuation of sirolimus
- Informed consent from participant, parent, or guardian
- Current vaccinations, including varicella-zoster (VZV) vaccine, before study enrollment
Exclusion Criteria:
- Recipient of a deceased donor kidney transplant
- Multiorgan transplant
- History of prior organ transplantation
- Participant sensitized to greater than 0% Panel Reactive Antibody (PRA) within 4 weeks before study enrollment. (If participant receives a blood transfusion status post PRA test, then the PRA must be repeated within 1 week of transplantation)
- Participants with human leukocyte antigen (HLA) identical living related donors
- History of primary focal segmented glomerulosclerosis
- History of other disorders requiring continuous maintenance steroids or calcineurin inhibitors
- Active systemic infection at time of transplant
- History of malignancy
- Infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- Contraindication to receive tacrolimus, sirolimus, MMF, or monoclonal antibody therapy
- Use of investigational drugs within 4 weeks before study enrollment
- Recipient of any licensed or investigational live attenuated vaccine(s) within 2 months before study enrollment
- Family history of high cholesterol
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Alemtuzumab (Campath)
In this open-label, single-arm trial , participants will be administered a 0.3 mg/kg dose of alemtuzumab (Campath) intravenously one day prior to kidney transplantation and one day post kidney transplantation.
Participants will then receive a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
|
Administered intravenously over a period of 2-3 hours.
Two doses total, the first will be one day before transplant and the second will be on the day following transplantation.
Pre-medication with methylprednisolone, acetaminophen, and Benadryl will be administered before each dose.
Otros nombres:
Administered orally at a dose of 0.05-0.1 mg/kg twice daily, beginning 1-3 days following transplantation and continuing until weeks 8-12.
Tacrolimus will be discontinued and a treatment regimen with sirolimus will be initiated between weeks 8-12 but some overlap with these medications is possible.
Otros nombres:
Per recommendation
Otros nombres:
Administered by either liquid or tablet every 12 hours from month 6 until month 24.
Dosage will vary throughout the treatment course.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The Proportion of Participants With Graft Loss or Death Within 12 Months Post Kidney Transplantation
Periodo de tiempo: Up to one year post kidney transplantation procedure
|
Graft loss is defined as the need for dialysis for more than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure.
|
Up to one year post kidney transplantation procedure
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Silla de estudio: William Harmon, MD, Boston Children's Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Watson CJ, Bradley JA, Friend PJ, Firth J, Taylor CJ, Bradley JR, Smith KG, Thiru S, Jamieson NV, Hale G, Waldmann H, Calne R. Alemtuzumab (CAMPATH 1H) induction therapy in cadaveric kidney transplantation--efficacy and safety at five years. Am J Transplant. 2005 Jun;5(6):1347-53. doi: 10.1111/j.1600-6143.2005.00822.x.
- Wolff G, Strecker K, Vester U, Latta K, Ehrich JH. Non-compliance following renal transplantation in children and adolescents. Pediatr Nephrol. 1998 Nov;12(9):703-8. doi: 10.1007/s004670050531.
- Ciancio G, Burke GW, Gaynor JJ, Mattiazzi A, Roohipour R, Carreno MR, Roth D, Ruiz P, Kupin W, Rosen A, Esquenazi V, Tzakis AG, Miller J. The use of Campath-1H as induction therapy in renal transplantation: preliminary results. Transplantation. 2004 Aug 15;78(3):426-33. doi: 10.1097/01.tp.0000128625.29654.eb.
- Rao V, Pirsch JD, Becker BN, Knechtle SJ. Sirolimus monotherapy following Campath-1H induction. Transplant Proc. 2003 May;35(3 Suppl):128S-130S. doi: 10.1016/s0041-1345(03)00227-6.
- Kreis H, Cisterne JM, Land W, Wramner L, Squifflet JP, Abramowicz D, Campistol JM, Morales JM, Grinyo JM, Mourad G, Berthoux FC, Brattstrom C, Lebranchu Y, Vialtel P. Sirolimus in association with mycophenolate mofetil induction for the prevention of acute graft rejection in renal allograft recipients. Transplantation. 2000 Apr 15;69(7):1252-60. doi: 10.1097/00007890-200004150-00009.
- De Serres SA, Mfarrej BG, Magee CN, Benitez F, Ashoor I, Sayegh MH, Harmon WE, Najafian N. Immune profile of pediatric renal transplant recipients following alemtuzumab induction. J Am Soc Nephrol. 2012 Jan;23(1):174-82. doi: 10.1681/ASN.2011040360. Epub 2011 Nov 3.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Renales
- Enfermedades urológicas
- Insuficiencia Renal Crónica
- Insuficiencia Renal Crónica
- Insuficiencia renal
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Inhibidores de enzimas
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antineoplásicos inmunológicos
- Agentes antibacterianos
- Antibióticos, Antineoplásicos
- Agentes antifúngicos
- Agentes antituberculosos
- Antibióticos, Antituberculosos
- Inhibidores de calcineurina
- Tacrolimus
- Ácido micofenólico
- Sirolimus
- Alemtuzumab
Otros números de identificación del estudio
- DAIT PC01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Datos del estudio/Documentos
-
Conjunto de datos de participantes individuales
Identificador de información: SDY134Comentarios de información: ImmPort study identifier is SDY134
-
Protocolo de estudio
Identificador de información: SDY134Comentarios de información: ImmPort study identifier is SDY134
-
Study summary, - schedule of events, -download packages et al.
Identificador de información: SDY134Comentarios de información: ImmPort study identifier is SDY134
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. .
Ensayos clínicos sobre Alemtuzumab
-
German CLL Study GroupTerminadoLeucemia linfocítica crónicaAlemania
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI); Genzyme, a Sanofi CompanyTerminado
-
Genzyme, a Sanofi CompanyTerminadoLinfoma no HodgkinEstados Unidos
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)RetiradoLinfomaEstados Unidos, Australia, Reino Unido, Canadá, Francia
-
Karolinska University HospitalSchering Nordiska ABTerminado
-
Latin American Cooperative Onco-Haematology Group...DesconocidoMicosis Fungoide | Síndrome de SézaryPerú
-
Genzyme, a Sanofi CompanyTerminadoNeoplasias malignas hematológicasEstados Unidos
-
Genzyme, a Sanofi CompanyTerminadoLeucemia linfocítica crónica de células BEstados Unidos
-
German CLL Study GroupTerminado
-
Genzyme, a Sanofi CompanyBayerTerminadoEsclerosis Múltiple Recurrente-RemitentePaíses Bajos, España, Alemania, Israel, Reino Unido, Canadá, Australia, Estados Unidos, Italia, Argentina, Croacia, Federación Rusa, Polonia, Chequia, Bélgica, Francia, Brasil, Austria, Dinamarca, México, Serbia, Suecia, Ucrania