Phase 2
N=1
C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection
Antibody Mediated Rejection of Kidney Transplant
Bottom Line
View on ClinicalTrials.gov: NCT02936479 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Renal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR) — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- C1-INH (Berinert) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR) |
1 | — |
Summary
This is an open-label, single arm trial in which patient who have ongoing antibody mediated rejection of a kidney transplant deemed refractory to maximal medical therapy are given the complement inhibitor C1-INH (Berinert) in an effort to protect the graft from ongoing antibody mediated injury. A maximum of 5 patients will be enrolled.
Eligibility Criteria
Inclusion Criteria
- Kidney transplant with acute antibody mediated rejection refractory to standard therapy
Exclusion Criteria
- Patients with known intolerance of or anaphylaxis to Berinert
Data sourced from ClinicalTrials.gov (NCT02936479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.