CCFZ533X2201 PoC study in de novo renal transplantatio

Phase 1

• Conditions: acute rejection of renal transplant in de novo adult renal transplant patients; MedDRA version: 19.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-000925-36-NL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-25
• Last Update Posted: 29 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

Main Inclusion Criteria:
• Written informed consent must be obtained before any assessment is performed.
• Recipients of a kidney transplant from a heartbeating deceased, living unrelated or nonhuman leukocyte antigen (HLA) identical living related donor.
• Recipients of a kidney with a cold ischemia time (CIT) < 30 hours.
• other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 276
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Main Exclusion Criteria:
•Recipients of an organ from a nonheart 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).
• other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified