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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 is a Phase 1 study that has completed, run by Stanley Jordan, MD. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01134510
The ClinicalTrials.gov registry entry for NCT01134510 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanley Jordan, MD, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT01134510 reports 0 study locations.
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.
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