Phase 2
N=59
CCFZ533X2201 - PoC Study in de Novo Renal Transplantation
Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT02217410 ↗Enrolled (actual)
59
Serious AEs
62.7%
Results posted
Dec 2018
Primary outcome: Primary: Mean Cmax Pharmacokinetic Parameter- Part I — 66.3 ug/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CFZ533 (Biological); Tacrolimus (Tac) (Drug); Mycophenolate mofetil (MMF) (Drug); Corticosteroids (CS) (Drug); anti-IL2 Induction (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Cmax Pharmacokinetic Parameter- Part I |
66.3 | — |
| PRIMARY Mean Tmax Pharmacokinetic Parameter - Part I |
0.237 | — |
| PRIMARY Mean AUClast Pharmacokinetic Parameter - Part I |
367 | — |
| PRIMARY Efficacy as Defined by the Frequency and Severity (Banff Classification) of Treated Biopsy Proven Acute Rejection (tBPAR) Adjudicated Data - Part II |
6; 2; 7; 3; 7; 3 | 0.8976 |
| SECONDARY Total Soluble CD40 and Total Soluble CD154 Concentrations in Plasma - Part 1 |
4.03; 0.125; 8.86; 0.0585; 16.7; 0.139 | — |
| SECONDARY Free CD40 and Total CD40 on B Cells - Part II |
30836.00; 12778.80; 1623.81; 13806.90; 799.62; 15160.38 | — |
| SECONDARY Anti-CFZ533 Antibodies - Part I |
— | — |
| SECONDARY Anti-CFZ533 Antibodies - Part II |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY eGFR - Part II |
9.8; 9.7; 55.6; 44.3; 58.2; 44.2 | — |
| SECONDARY CFZ533 Plasma PK Concentrations - Part II |
247; 211; 178; 157; 148; 147 | — |
| SECONDARY Total sCD40 Plasma Concentrations - Part II |
3.02; 3.67; 6.95; 1.16; 24.6; 1.16 | — |
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.
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT02217410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.