Study Stopped
Stopping rule-acute rejection threshold-was met based on local biopsy results
Belatacept to Prevent Organ Rejection in Kidney Transplant Patients
BESTT
The Safety and Efficacy of Belatacept, Antithymocyte Globulin, and Sirolimus in Recipients of Non-HLA-identical Living-donor Renal Transplants (ITN023ST)
1 other identifier
interventional
5
1 country
2
Brief Summary
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rejection of a first-time, non-human leukocyte antigen (HLA) identical renal transplant and allow patients to be safely withdrawn from anti-rejection therapy one year post-transplant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2006
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2006
CompletedFirst Posted
Study publicly available on registry
June 29, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
November 7, 2011
CompletedApril 21, 2017
March 1, 2017
3.2 years
June 27, 2006
June 8, 2011
March 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute Rejection at 6-Months
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
Secondary Outcomes (14)
Participant Survival at 12 Months Post-Transplant
12 months post-transplant
Acute Rejection at 12-Months
12 months post-transplant
Tolerance Induction
48 months
Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks
24 weeks post-transplant
Graft Survival at 12 Months Post-transplant
12 months post-transplant
- +9 more secondary outcomes
Study Arms (1)
Belatacept
EXPERIMENTALImmunosuppressive protocol consisting of belatacept, glucocorticoids, antithymocyte globulin (ATG), and sirolimus.
Interventions
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
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
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.
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
Eligibility Criteria
You may qualify if:
- Receiving first renal (e.g., kidney) transplant
- Transplant is from a non-HLA-identical living donor
- Willing to use acceptable forms of contraception
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of California, San Francisco
San Francisco, California, 94143, United States
Emory University
Atlanta, Georgia, 30322, United States
Related Publications (1)
Vincenti F, Larsen C, Durrbach A, Wekerle T, Nashan B, Blancho G, Lang P, Grinyo J, Halloran PF, Solez K, Hagerty D, Levy E, Zhou W, Natarajan K, Charpentier B; Belatacept Study Group. Costimulation blockade with belatacept in renal transplantation. N Engl J Med. 2005 Aug 25;353(8):770-81. doi: 10.1056/NEJMoa050085.
PMID: 16120857BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The trial was stopped early due to meeting an acute rejection threshold of three acute rejections based on local pathology reads in the first five participants enrolled.
Results Point of Contact
- Title
- Director, Clinical Research Program
- Organization
- DAIT/NIAID
Study Officials
- PRINCIPAL INVESTIGATOR
Flavio Vincenti, MD
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Christian Larsen, MD
Emory University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2006
First Posted
June 29, 2006
Study Start
December 1, 2006
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
April 21, 2017
Results First Posted
November 7, 2011
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
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.