Efficacy and Safety of Eculizumab for Treatment of Antibody-mediated Rejection Following Renal Tr… (NCT01895127) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of Eculizumab for Treatment of Antibody-mediated Rejection Following Renal Transplantation
Stopped: Lack of efficacy
United States11 participantsStarted 2013-11
Plain-language summary
This is an open-label analysis that will compare eculizumab versus Plasmapheresis (PP) and Immunoglobulin (IVIg) for the treatment of antibody-mediated rejection (AMR) in renal transplant recipients. All patients will be evaluated from the time of AMR diagnosis for 12 months.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Adult renal transplant recipients, men and women between 18 and 75 years of age.
✓. Any patient with acute graft dysfunction (elevation of creatinine above post transplant nadir)
✓. Presence of circulating anti human leukocyte antigen (HLA) antibody (DSA "donor specific antibody").
✓. Histological findings compatible with Banff Class II or III AMR on transplant biopsy.
✓. Peritubular capillary c4d positivity on transplant biopsy.
Exclusion criteria
✕. Patients that have received eculizumab prior to enrolling in the study.
✕. Patients with ongoing non-acute antibody mediated rejection.
✕. Patients with predominantly chronic antibody mediated rejection or interstitial fibrosis/tubular atrophy.
✕. History of severe cardiac disease (e.g., New York Heart Association \[NYHA\] Functional Class III or IV, myocardial infarction ≤ 6 months of randomization, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases)
✕. Prior splenectomy
✕. Has a known bleeding disorder
✕. Has any active bacterial or other infection which is clinically significant in the opinion of the Investigator and is a contraindication to transplantation
What they're measuring
1
Percent Change in Estimated Glomerular Filtration (eGFR) Rate