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Belatacept to Prevent Organ Rejection in Kidney Transplant Patients (BESTT)
This study is currently recruiting participants.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), December 2008
Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00346151
  Purpose

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can prevent the rejection of a first-time, non-HLA identical kidney transplant and allow patients to be safely withdrawn from anti-rejection therapy one year post-transplant.


Condition Intervention Phase
Transplantation, Kidney
End-Stage Renal Disease
Drug: Belatacept
Drug: Sirolimus
Drug: Anti-thymocyte globulin
Drug: methylprednisolone
Phase II

MedlinePlus related topics: Kidney Failure Kidney Transplantation
Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Prednisone Sirolimus Abatacept Dacliximab Benzocaine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: The Safety and Efficacy of Belatacept, Daclizumab, and Sirolimus in Recipients of Non-HLA-Identical Living-Donor Renal Transplants

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Incidence of acute rejection at 6 months post-transplant [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Graft and patient survival at 12, 24, 36, and 48 months post-transplant [ Time Frame: 12, 24, 36, and 48 months ] [ Designated as safety issue: Yes ]
  • immunosuppressive-related and metabolic complications [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
  • tolerance induction [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • laboratory measures predictive of tolerance or rejection [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2006
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Treatment arm
Drug: Belatacept
10 mg/kg IV on transplant (day 1), day 5, and at weeks 2, 4, 8 and 12, then 5 mg/kg IV every 4 weeks
Drug: Sirolimus
4 mg/day on transplant, then dose adjust to maintain 8-12 ng/mL for at least 1 year
Drug: Anti-thymocyte globulin
1.5 mg/kg IV daily on transplant (day 1) through day 4
Drug: methylprednisolone
500 mg IV at transplant (day 1), then 250 mg IV on day 2 and 0.5 mg/kg IV or prednisone 0.5 mg/kg PO on days 3 and 4

Detailed Description:

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 a medication schedule consisting of thymoglobulin, sirolimus, and belatacept. Participants will receive infusions of thymoglobulin on days 1 though , 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receiving first kidney transplant
  • Transplant is from a non-HLA-identical living donor
  • Willing to use acceptable forms of contraception

Exclusion Criteria:

  • Positive for antihuman 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.
  • HIV infected
  • Hepatitis B or C virus infected
  • Other active infections
  • Active tuberculosis infection within the 3 years prior to study entry
  • Pregnancy or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346151

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: JoAnn Zlatunich, RN     415-476-3496     ZlatunichJ@surgery.ucsf.edu    
Contact: Clarina Mendoza     (415) 476-5979     mendozacl@surgery.ucsf.edu    
Principal Investigator: Flavio Vincenti, MD            
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Beth Begley, RN, BSN, CCTC     (404) 712-7168     beth_begley@emoryhealthcare.org    
Principal Investigator: Christian Larsen, MD            
Sponsors and Collaborators
Immune Tolerance Network
Investigators
Principal Investigator: Flavio Vincenti, MD University of California, San Francisco
Principal Investigator: Christian Larsen, MD Emory University
  More Information

Click here for the Immune Tolerance Network Web site  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: DAIT/NIAID ( Associate Director, Clinical Research Program )
Study ID Numbers: ITN023ST
Study First Received: June 27, 2006
Last Updated: December 9, 2008
ClinicalTrials.gov Identifier: NCT00346151  
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Kidney Transplant
Kidney Transplantation
Renal Transplant
Transplantation
Renal Transplantation
Kidney Failure
Renal Failure
Kidney Disease
Renal Disease
Living Donor

Study placed in the following topic categories:
Sirolimus
Prednisone
Renal Insufficiency
Clotrimazole
Methylprednisolone
Miconazole
Daclizumab
Tioconazole
Benzocaine
Kidney Failure, Chronic
Methylprednisolone acetate
Prednisolone acetate
Antilymphocyte Serum
Abatacept
Urologic Diseases
Renal Insufficiency, Chronic
Prednisolone
Kidney Diseases
Kidney Failure
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Antineoplastic Agents, Hormonal
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Antibiotics, Antineoplastic
Hormones
Glucocorticoids
Immunosuppressive Agents
Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Anti-Bacterial Agents
Autonomic Agents
Antifungal Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009