Trial · NCT01025193
Desensitization With Belimumab in Sensitized Patients Awaiting Kidney Transplant
NCT01025193, Phase 2, Terminated, University of Pennsylvania; results first posted 2017-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Desensitization With Belimumab in Sensitized Patients Awaiting Kidney Transplant. Trials, record NCT01025193. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01025193
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Desensitization With Belimumab in Sensitized Patients Awaiting Kidney Transplant
- NCT number
- NCT01025193
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Desensitization
- Interventions
- Belimumab
- First posted
- 2009-12-03
- Last updated
- 2017-06-12
- Results first posted
- 2017-02-28
- Limitations and caveats
Few patients enrolled, and limited follow-up due to trial being halted due to lack of efficacy after review by investigators and the data safety monitoring board. Only one patient was transplanted during the trial (unrelated to study treatment).
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effectiveness of Belimumab to Normalize Allo-antibody Levels in Sensitized Patients Awaiting Kidney Transplantation. | 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. |
| Primary | Successful Kidney Transplantation From a Cross-match Compatible Donor (as a Result of Belimumab Therapy) | 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. |
| Secondary | Pharmacokinetics of Belimumab Measured as Number of Participants With Specific Dilution Factors at Each Time Point. | 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. |
| Secondary | B and T Lymphocyte Subsets | 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. |
| Secondary | BLyS Levels Before and After Treatment With Belimumab | 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. |
| Secondary | Hepatitis B Vaccine Antibody Titers | 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. |
| Secondary | Number of Participants With Treatment Related Serious Adverse Events | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Effectiveness of Belimumab to Normalize Allo-antibody Levels in Sensitized Patients Awaiting Kidney Transplantation. | up to one year pre-transplant | any patient who received at least one dose of belimumab was included in analysis population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Successful Kidney Transplantation From a Cross-match Compatible Donor (as a Result of Belimumab Therapy) | one year pre-transplant | All participants enrolled who received at least one dose of belimumab were considered for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics of Belimumab Measured as Number of Participants With Specific Dilution Factors at Each Time Point. | 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. | any patient who received at least one dose of belimumab was included in the analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | B and T Lymphocyte Subsets | 8 weeks after the last dose of belimumab | Any patient who received at least one dose of belimumab was included in the analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | BLyS Levels Before and After Treatment With Belimumab | up to 8 weeks after completion of therapy | Any patient who received at least one dose of belimumab was included in the analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hepatitis B Vaccine Antibody Titers | up to 12 months of treatment with belimumab | All patients who received at least one dose of belimumab were included in the analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Related Serious Adverse Events | up to one year pre-transplant | Any patient who received at least one dose of belimumab was included in the analysis | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Effectiveness of Belimumab to Normalize Allo-antibody Levels in Sensitized Patients Awaiting Kidney Transplantation. | Belimumab | Patients not experiencing a decrease in antibodies | 8 | Participants | |
| Effectiveness of Belimumab to Normalize Allo-antibody Levels in Sensitized Patients Awaiting Kidney Transplantation. | Belimumab | Patients experiencing a decrease in antibodies | 0 | Participants | |
| Successful Kidney Transplantation From a Cross-match Compatible Donor (as a Result of Belimumab Therapy) | Belimumab | Kidney transplant as a result of belimumab therapy | 0 | Participants | |
| Successful Kidney Transplantation From a Cross-match Compatible Donor (as a Result of Belimumab Therapy) | Belimumab | kidney transplant unrelated to belimumab therapy | 1 | Participants | |
| Successful Kidney Transplantation From a Cross-match Compatible Donor (as a Result of Belimumab Therapy) | Belimumab | Kidney transplant not received during trial | 7 | Participants | |
| Pharmacokinetics of Belimumab Measured as Number of Participants With Specific Dilution Factors at Each Time Point. | Belimumab | Pre Dose Belimumab Serum Dilution at 400-Day 0 | 8 | Participants | |
| Pharmacokinetics of Belimumab Measured as Number of Participants With Specific Dilution Factors at Each Time Point. | Belimumab | Pre Dose Belimumab Serum Dilution at 8000-Day 56 | 7 | Participants | |
| Pharmacokinetics of Belimumab Measured as Number of Participants With Specific Dilution Factors at Each Time Point. | Belimumab | Pre Dose Belimumab Dilution 8000 at Day 364 | 2 | Participants | |
| Pharmacokinetics of Belimumab Measured as Number of Participants With Specific Dilution Factors at Each Time Point. | Belimumab | Post Dose Belimumab Dilution at 8000 at Day 14 | 7 | Participants | |
| Pharmacokinetics of Belimumab Measured as Number of Participants With Specific Dilution Factors at Each Time Point. | Belimumab | Post Dose Belimumab Dilution at 8000 at Day 168 | 6 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Belimumab | 8 | |
| Overall Study | COMPLETED | Belimumab | 4 | |
| Overall Study | NOT COMPLETED | Belimumab | 4 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rash left antecubitus from adhesive tape | Skin and subcutaneous tissue disorders | Belimumab | 1 | 8 | 1 |
| other | Hypertensive episode | Renal and urinary disorders | Belimumab | 1 | 8 | 1 |
| other | Electrolyte imbalance | Renal and urinary disorders | Belimumab | 1 | 8 | 1 |
| other | Nausea | Gastrointestinal disorders | Belimumab | 1 | 8 | 1 |
| other | non-cardiac related chest pain | General disorders | Belimumab | 1 | 8 | 1 |
| other | Shakiness | General disorders | Belimumab | 1 | 8 | 1 |
| other | anemia (low red blood cell count) | Blood and lymphatic system disorders | Belimumab | 1 | 8 | 1 |
| other | fluid overload | Renal and urinary disorders | Belimumab | 1 | 8 | 2 |
| other | infection cold symptoms | Infections and infestations | Belimumab | 1 | 8 | 1 |
| other | partial parathyroidectomy | Endocrine disorders | Belimumab | 1 | 8 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Belimumab | ||
| Total, other adverse events | Belimumab | 6 | 8 |
| Total, serious adverse events | Belimumab | 3 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01025193
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