Cyclophosphamide Therapy for Refractory Antibody-Mediated Rejection (AMR) in Kidney Transplants

• Status: Terminated
• Trial end date: 2018-01-18
• Target enrollment: 0
• Participant gender: All

Summary

The study hypothesis is that short-term low dose cyclophosphamide therapy will be effective in resolving inflammation in patients with late phase antibody-mediated rejection refractory to current standard of care treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manitoba
• Treatments: Antibodies; Cyclophosphamide

Criteria

Inclusion Criteria:

• Patients with a living or deceased donor kidney transplant

• Failed current standard of care for late antibody-mediated rejection

• Persistent de novo donor specific antibody and a concurrent biopsy with histologic evidence of acute antibody-mediated inflammation

• Adults with reproductive potential must agree to use approved methods of birth control while in the study

Exclusion Criteria:

• Leukopenia (WBC) < 3.0 x 109/L

• Creatinine Clearance less than or equal to 25 ml/min/1.73m2

• HCV or HBV positive

• BKV or CMV viremia assessed by PCR

• Any active infection

• Use of other investigational drugs within 4 weeks of study

• Pregnancy/breast feeding/unwilling or unable to take birth control

• Active malignancy

• de novo DSA occurring equal to or greater than15 years after kidney transplant

• Screening biopsy with equal to or greater than cg2 on Banff criteria

• Cumulative/lifetime dose of cyclophosphamide, including anticipated total study dose (calculated according to Creatinine Clearance and mg/kg/day) equal to or greater than 36 g.

• Any condition that, in the opinion of the investigator, would pose risk to the subject's safe participation in the study