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

Phase 2

Recruiting

Conditions: niertransplantatie
kidney transplantation
10038430

Registration Number: NL-OMON45886

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

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.;See protocol for more details and other inclusion criteria.

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).;See protocol for more details and other exclusion criteria.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Treated biopsy proven acute rejection (tBPAR), graft loss, death, estimated<br /><br>GFR<br /><br>* Renal function<br /><br>* Adverse and serious adverse events<br /><br>* Infections<br /><br>* Cytokines<br /><br>* Donor specific antibodies<br /><br>* NODAT<br /><br>* EBV, CMV and BK virus and tuberculosis surveillance<br /><br>* Viral serology<br /><br>* Immunogenicity<br /><br>* ECG<br /><br>* Vital signs<br /><br>* Clinical labs</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Pharmacokinetics:<br /><br>* Free CFZ533 in plasma<br /><br>* Tac trough levels<br /><br>* MPA trough levels<br /><br>* Pharmacodynamics:<br /><br>* Peripheral blood CD40 receptor occupancy (free CD40, total CD40 on B cells)<br /><br>* Immunophenotyping<br /><br>* Soluble CD40 and soluble CD154 in plasma<br /><br>* Graft survival<br /><br>* Patient survival<br /><br>* Lymph node / tissue biopsy<br /><br>* Renal biomarkers<br /><br>* Pharmacogenetics<br /><br>* Pharmacogenomics</p><br>