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

Withdrawn before enrolling · Phase 2

Conditions studied: Graft Rejection, Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT01035593

Run by

Pharming Technologies B.V.

People needed

0

Starts

2010-12-01

Expected to finish

2011-12-01

Last updated by the study team

2012-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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