Status:
COMPLETED
CCFZ533X2201 - PoC Study in de Novo Renal Transplantation
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 r...
Eligibility Criteria
Inclusion
- Main
- 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
- 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).
Key Trial Info
Start Date :
February 5 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2017
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT02217410
Start Date
February 5 2015
End Date
November 29 2017
Last Update
September 28 2021
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Aurora, Colorado, United States, 80045
2
Novartis Investigative Site
Baltimore, Maryland, United States, 21201
3
Novartis Investigative Site
Ann Arbor, Michigan, United States, 48109 5271
4
Novartis Investigative Site
Detroit, Michigan, United States, 48202