Recombinant Human C1 Inhibitor for the Treatment of Early Antibody-Mediated Rejection in Renal Transplantation

• Status: Withdrawn
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Pharming Technologies B.V.
• Collaborator: University of Wisconsin, Madison
• Treatments: Antibodies; Complement C1 Inactivator Proteins; Immunoglobulins, Intravenous

Criteria

Inclusion Criteria:

• Recipients of renal transplantation within 30 days prior to enrollment.

• AMR documented by light microscopic changes and immunohistochemical C4d staining on renal biopsy within 30 days post-transplant.

• Positive DSA as detected by magnetic microbeads using a Luminex® system.

• Age ≥ 18 years.

• Women of child-bearing potential (CBP) must have negative pregnancy test at screening.

• Women of CBP and men with sexual partners of CBP must agree to use a medically acceptable method of contraception throughout the study and for 3 months following discontinuation of assigned treatment.

• Subjects must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.

Exclusion Criteria:

• Recipients of multi-organ transplants.

• Recipients with previous early AMR.

• Recipients with a known hypersensitivity to C1INH, rabbit anti-thymocyte globulin, or any rabbit protein.

• History of malignancy within 3 years of enrollment (except for adequately treated basal cell or squamous cell carcinoma of the skin).

• Subjects who are positive for hepatitis C, hepatitis B surface antigen, or HIV at the time of transplant.

• Subjects who are actively taking an investigational drug.

• Subjects with a history of a psychological illness or condition that could interfere with the subject's ability to understand the requirements of the study.

• Female subjects who are pregnant or nursing.

• Subjects with hemodynamic instability, as defined by a mean arterial pressure (MAP) <60 mmHg or >110 mmHg; or requirement of vasopressors to maintain a MAP of 60 mmHg; or requirement of IV vasodilators for hypertensive emergency; or acute pulmonary edema.

• Subjects with known active infection at the time of enrollment.

• Biopsy-confirmed concurrent cellular rejection requiring polyclonal antibody therapy (i.e., all Grades other than Banff 1a and 1b will be excluded).