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NCT01134510 · ClinicalTrials.gov registry record · Phase 1
Safety & Tolerability of Berinert® (C1 Inhibitor) Therapy to Prevent Rejection
A Phase 1 study, sponsored by Stanley Jordan, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01134510: Completed Phase 1 study, sponsored by Stanley Jordan, MD.
NCT01134510 is a Phase 1 study that has completed, run by Stanley Jordan, MD. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01134510, a Phase 1 study, has completed, sponsored by Stanley Jordan, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Organ transplantation offers the only hope for a normal life for patients with end-stage renal disease on dialysis (ESRD). For the highly-sensitized patient, patients with antibodies to human leukocyte antigens (HLA), transplantation is extremely difficult or impossible since pre-formed antibodies will cause severe rejection and loss of transplanted organs. Approximately 30% of the transplant list in the U.S. is considered sensitized (have detectable antibodies to HLA antigens). These anti-HLA (anti-Human Leukocyte Antigen antibodies) pose a significant barrier to transplantation that has recently been successfully addressed using desensitization therapies with IVIG, rituximab and/or plasmapheresis (PE). Despite the success of these therapies, post-transplant antibody mediated rejection (AMR) and chronic Antibody Mediated Rejection (CAMR) remain significant problems. Recent data suggests that addition of Berinert (C1 Inhibitor) to post-transplant treatment regimen may significantly reduce incidence of Antibody Mediation Rejection. Twenty highly-sensitized patients who have undergone desensitization treatment and are awaiting kidney transplant will be enrolled in the study. Once transplanted these patients will be started on the standard of care post-transplant immunosuppressive protocol. In addition patients will receive Berinert 20 units/ kg daily x 3 days, then twice weekly x 3 weeks. At the end of Berinert treatment a kidney biopsy will be performed. Subjects will be followed for 6 months to assess safety and efficacy of the study protocol.
Primary Outcome
Subjects will have a routine kidney biopsy 6 month after transplant to screen for episodes of acute rejection. For purposes of this investigation, antibody-mediated rejection (AMR) is defined as follows: * Deterioration of allograft function in a high-risk transplant recipient (i.e. sensitized patient with history of Donor Specific Antibodies) measured by serum Creatinine and estimated Glomerular Filtration Rate * Association with the presence of Donor Specific Antibody (usually increasing in
Interventions
- DRUG Placebos
- DRUG C1 Esterase Inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
What the finished NCT01134510 record still lists
NCT01134510 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT01134510 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01134510 about?
NCT01134510 is a clinical study titled "Safety & Tolerability of Berinert® (C1 Inhibitor) Therapy to Prevent Rejection". Organ transplantation offers the only hope for a normal life for patients with end-stage renal disease on dialysis (ESRD). For the highly-sensitized patient, patients with antibodies to human leukocyte antigens (HLA), transplantation is extremely difficult or impossible since pre-formed antibodies w...
What is the current status of trial NCT01134510?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-08. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01134510?
The interventions under investigation include: Placebos (DRUG), C1 Esterase Inhibitor (DRUG).
Who is sponsoring clinical trial NCT01134510?
This trial is sponsored by Stanley Jordan, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01134510's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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