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NCT01025193 · ClinicalTrials.gov registry record · Phase 2
Desensitization With Belimumab in Sensitized Patients Awaiting Kidney Transplant
A Phase 2 study, sponsored by University of Pennsylvania.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT01025193: Clinical Trial Phase 2 study, sponsored by University of Pennsylvania.
NCT01025193 is a Phase 2 study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01025193, a Phase 2 study, was terminated before completion, sponsored by University of Pennsylvania.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
If subjects are listed for kidney transplant and are considered sensitized, this means they have a high amount of antibodies in their blood that could react to a kidney transplant offered for them. Antibodies are protein substances made by the body that fight anything that the body considers as a threat to it, such as infection or a kidney transplant. Sensitization may be due to prior transplants, pregnancy, or blood transfusions. Being sensitized can increase the subject's kidney transplant waiting time as it is more difficult to find a suitable kidney transplant for them that their antibodies will not react to. The purpose of this research study is to see if giving the investigational drug belimumab up to one year pre-transplant can de-sensitize the subjects, or decrease the amount of antibodies in their blood. This may help make the subjects eligible to receive a kidney transplant more quickly. If after receiving belimumab, the subjects are compatible with a donor kidney offered and are medically suitable for transplant at that time, a kidney transplant will be performed.
Primary Outcome
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 anti
Interventions
- DRUG Belimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
Why NCT01025193 stopped before completion
NCT01025193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Belimumab is the first listed.
NCT01025193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01025193 about?
NCT01025193 is a clinical study titled "Desensitization With Belimumab in Sensitized Patients Awaiting Kidney Transplant". If subjects are listed for kidney transplant and are considered sensitized, this means they have a high amount of antibodies in their blood that could react to a kidney transplant offered for them. Antibodies are protein substances made by the body that fight anything that the body considers as a th...
What is the current status of trial NCT01025193?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2010-02. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01025193?
The interventions under investigation include: Belimumab (DRUG).
Who is sponsoring clinical trial NCT01025193?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01025193's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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