CCFZ533X2201 - PoC Study in de Novo Renal Transplantation
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/23/2018 |
| Start Date: | February 5, 2015 |
| End Date: | November 29, 2017 |
A 12-month Randomized, Multiple Dose, Open-label, Study Evaluating Safety, Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) and Efficacy of an Anti-CD40 Monoclonal Antibody, CFZ533, in Combination With Mycophenolate Mofetil (MMF) and Corticosteroids (CS), With and Without Tacrolimus (Tac), in de Novo Renal Transplant Recipients
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.
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.
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).
We found this trial at
7
sites
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