Recombinant Human C1 Inhibitor for the Treatment of Early Antibody-Mediated Rejection in Renal Transplantation
| Status: | Archived |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Orthopedic |
| Therapuetic Areas: | Nephrology / Urology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | December 2010 |
| End Date: | December 2011 |
The purpose of this study will be to assess the safety, tolerability, and efficacy of
rhC1INH in renal transplant recipients with biopsy-confirmed antibody-mediated rejection
(AMR) within 30 days of renal transplantation. This study will combine the investigational
drug rhC1INH with a standard regimen of plasmapheresis (PP) and intravenous immune globulin
(IVIG) and compare this to PP and IVIG alone.
This is an Investigator-initiated, prospective, open-label, randomized, adaptive design
study to enroll 30 adult renal transplant recipients with biopsy-confirmed AMR within 30
days post transplantation. After informed consent is obtained and study eligibility is
confirmed, subjects will be enrolled immediately after biopsy confirmation of AMR and
positive donor specific antibody (DSA). Subjects will then be randomized into one of two
treatment groups (SOC [control] or rhC1INH). An initial cohort of 8 subjects (3 SOC, 5
rhC1INH) will receive intensive safety monitoring of the coagulation system and for
thromboembolic events.
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