| Trial ID: | L1429 |
| Source ID: | NCT02130817
|
| Associated Drug: |
Belatacept
|
| Title: |
Belatacept in Kidney Transplantation of Moderately Sensitized Patients
|
| Acronym: |
BelatPilot
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease|Antibody Mediated Rejection
|
| Interventions: |
DRUG: Belatacept|DRUG: Tacrolimus withdrawal|PROCEDURE: Plasmapheresis/Intravenous Immunoglobulin G|DRUG: Thymoglobulin (ATG)|DRUG: Myfortic|DRUG: Steroids
|
| Outcome Measures: |
Primary: Acute rejection, Acute rejection rates are based on assessment of standard of care biopsy (protocol and indication) and standard Banff criteria., one year | Secondary: Patient and Graft Survival, The number of subjects alive and with functioning grafts at one year., One year|Incidence of infections, Number of subjects in the study who have developed infections, including cytomegalovirus (CMV) and BK Virus, in the first year post-transplant, One year|Incidence of de novo donor specific antibody (DSA), Number of subjects who have developed donor specific antibodies at one year post transplant., One year|Incidence of new onset diabetes, Number of subjects in the study who have developed new onset diabetes since receiving the transplant, One year|Increase in estimated Glomerular Filtration Rate (eGFR), Number of subjects in the study whose eGFR has decreased to \< 45 milliliters/ minute, One year|Incidence of malignancies, Number of subjects in the study who have developed malignancies including post-transplant lymphoproliferative (PTLD) disorder, One year
|
| Sponsor/Collaborators: |
Sponsor: University of Wisconsin, Madison | Collaborators: Bristol-Myers Squibb
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-09-24
|
| Completion Date: |
2015-10-09
|
| Results First Posted: |
|
| Last Update Posted: |
2018-12-17
|
| Locations: |
University of Wiscsonsin Hospital and Clinics, Madison, Wisconsin, 53792, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02130817
|
