Desensitization With Belimumab in Sensitized Patients Awaiting Kidney Transplant
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|ClinicalTrials.gov Identifier: NCT01025193|
Recruitment Status : Terminated (has not demonstrated efficacy in primary goal)
First Posted : December 3, 2009
Results First Posted : February 28, 2017
Last Update Posted : June 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Desensitization||Drug: Belimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||There was only one group in this trial. All participants received belimumab.|
|Masking:||None (Open Label)|
|Masking Description:||There was no masking in this single group trial. The patients, providers and investigators were all aware that the patient were on belimumab therapy.|
|Official Title:||One Year Exploratory Study to Evaluate the Efficacy and Safety of Belimumab for Normalization of Alloantibody Levels in Sensitized Patients Awaiting Kidney Transplantation|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||November 2011|
Belimumab will be administered intravenously at a dose of 10mg/kg on days 0, 14, 28 and every 28 days for up to 52 weeks to normalize alloantibody levels in sensitized patients awaiting kidney transplantation. Subjects who are not able to undergo transplantation before the end of the treatment period will have final follow-up evaluation 8 weeks after the last dose of belimumab is administered.
Belimumab is a fully human monoclonal antibody that recognizes and inhibits BLyS ®. BLyS ® is a B-lymphocyte stimulator protein which plays a role in the development of B lymphocyte cells into plasma B cells, which then produce antibodies that can sensitize a potential transplant recipient. At the time of this trial, belimumab was not yet FDA approved and was being studied in clinical trials for the treatment of systemic lupus erythematosus. Until this trial, it had not yet been used in the transplant setting.
- Effectiveness of Belimumab to Normalize Allo-antibody Levels in Sensitized Patients Awaiting Kidney Transplantation. [ Time Frame: up to one year pre-transplant ]Before transplant it is necessary to measure antibodies that the recipient might have and compare them to the living or decease donor's immune make-up. Recipients with many antibodies or a specific antibody in a high concentration may have a more difficult time finding a compatible donor, and being transplanted. These recipients are referred to as sensitized patients. It is important that the sensitized recipient and the donor be compatible to prevent rejection after transplant. We measured antibodies levels in sensitized patients waiting for kidney transplant, to see if belimumab would decrease these antibody levels.
- Successful Kidney Transplantation From a Cross-match Compatible Donor (as a Result of Belimumab Therapy) [ Time Frame: one year pre-transplant ]In order for a sensitized recipient ( a recipient with antibodies) to be transplanted, the cross match with the donor has to be compatible. We wanted to study if belimumab reduced antibodies in sensitized patients and led those patients to subsequently become cross-match compatible with a donor and allow for successful transplant.
- Pharmacokinetics of Belimumab Measured as Number of Participants With Specific Dilution Factors at Each Time Point. [ Time Frame: Belimumab serum drug dilution factors were measured in patients at at timepoints 0 (first day of belimumab), day 14, day 56, day 168, 364, at any unscheduled visits, and at 8 weeks post completion of belimumab therapy. ]We wanted to look at belimumab pharmacokinetics in sensitized patients awaiting kidney transplant. These are reported as number of participants with specific dilution factors at each studied time-point. Blood for these tests could be drawn pre dose as well as 0-4 hours after the dose was given. Belimumab dilutions factors were measured pre dose at timepoints 0 (first day of belimumab), days 56 and 364. Belimumab dilution factors were measured after the dose on days 14, and 168. Belimumab dilution factors were also measured at 8 weeks after completion of belimumab therapy and pre dose at any unscheduled visits if needed.
- B and T Lymphocyte Subsets [ Time Frame: 8 weeks after the last dose of belimumab ]B and T Lymphocyte subsets were measured through flow cytometry pre-treatment and at months 1,2,12 and at 8 weeks after the last belimumab dose. We looked for clinically significant changes (as determined by Principal Investigator) in these subsets at each time-point.
- BLyS Levels Before and After Treatment With Belimumab [ Time Frame: up to 8 weeks after completion of therapy ]We assessed for unexpected changes in bound and unbound BLyS levels before and after treatment with belimumab. These were measured from before treatment and at months 1,2,6,10 and 12 months after belimumab treatment and again at 8 weeks after belimumab treatment.
- Hepatitis B Vaccine Antibody Titers [ Time Frame: up to 12 months of treatment with belimumab ]We investigated if belimumab treatment would decrease Hepatitis B vaccine titers by 12 months after treatment with belimumab. All patients received Hepatitis B vaccine before beginning treatment with belimumab.
- Number of Participants With Treatment Related Serious Adverse Events [ Time Frame: up to one year pre-transplant ]To assess the safety of belimumab in sensitized patients awaiting kidney transplant we evaluated the number of participants with serious adverse events possibly or definitely related to belimumab.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01025193
|United States, Pennsylvania|
|University of Pennsyvlania Kidney Transplant Program|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Ali Naji, MD, Ph D||University of Pennsylvania|