CCFZ533X2201 - PoC Study in de Novo Renal Transplantation

• Status: Completed
• Trial end date: 2017-11-29
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar rate of acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Main Inclusion Criteria:

• Written informed consent must be obtained before any assessment is performed.

• Recipients of a kidney transplant from a heart-beating deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor.

• Recipients of a kidney with a cold ischemia time (CIT) < 30 hours.

Main Exclusion Criteria:

• Recipients of an organ from a non-heart beating donor.

• ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant.

• Subjects receiving a second kidney allograft, unless the first allograft was lost due to surgical complication.

• Subjects at high immunological risk for rejection

• Subjects at risk for tuberculosis (TB)

• Subject with severe systemic infections, current or within the two weeks prior to randomization/enrollment.

• Any additional contraindication to the use of tacrolimus or mycophenolate mofetil according to the national labeling information of these products (see local product label).