Conditions: Antibody-mediated Rejection Humoral Rejection
Keywords: Kidney Transplant Renal Transplant Rejection Antibody mediated Humoral Eculizumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 11
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: * Plasmapheresis (PP) x 3, at 40-60 cc/kg.
* Immunoglobulin (IVIg), to be administered after each PP arm 2: * 1200 mg first dose (Time: Screening/Week "0", after Biopsy Proven AMR)
* 900 mg weekly for 4 doses (Weeks 1, 2, 3, 4)
* 1200 mg week 5
* Week 6: If donor specific antibody \< 50% of baseline DSA then no further treatment, otherwise 1200 mg weeks 7, 9

Interventions: intervention 1: Eculizumab intervention 2: Immunoglobulin intervention 3: Plasmapheresis
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: