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Completed

NCT Number: NCT02217410

CCFZ533X2201 - PoC Study in de Novo Renal Transplantation

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Novartis Investigative Site, São Paulo, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CFZ533

Biological

Tacrolimus (TAC)

Drug

Mycophenolate Mofetil (MMF)

Drug

Corticosteroids (CS)

Drug

anti-IL2 Induction

Biological

Primary outcomes

  1. Mean Cmax Pharmacokinetic Parameter- Part I

    Time frame: Day 1

    Pharmacokinetics as defined by the systemic concentrations and Cmax of certain immunosuppressant medications used in Part I

  2. Mean Tmax Pharmacokinetic Parameter - Part I

    Time frame: Day 1

    Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods.

  3. Mean AUClast Pharmacokinetic Parameter - Part I

    Time frame: Day 1

    Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods.

  4. Efficacy as Defined by the Frequency and Severity (Banff Classification) of Treated Biopsy Proven Acute Rejection (tBPAR) Adjudicated Data - Part II

    Time frame: 3, 6, 9, and 12 months

    To assess the activity of the investigational arm as compared to the standard of care control arm in de novo renal transplant patients as measured by the frequency and severity of tBPAR as measured on the Banff classification scale.

    An adjudication was performed on all on cause renal biopsies by an independent expert committee blinded to therapy.

Secondary outcomes

  1. Total Soluble CD40 and Total Soluble CD154 Concentrations in Plasma - Part 1

    Time frame: Baseline to end of study (Day 1, Day 29, Day 337)

    To quantify the change from baseline and recovery of peripheral blood total soluble CD40 and total soluble CD154

  2. Free CD40 and Total CD40 on B Cells - Part II

    Time frame: Baseline to end of study (Day 1/predose)

    The magnitude and duration of peripheral blood CD40 occupancy. MESF: molecules of equivalent soluble fluorochrome

  3. Anti-CFZ533 Antibodies - Part I

    Time frame: Baseline to end of study

    To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies

  4. Anti-CFZ533 Antibodies - Part II

    Time frame: Baseline to end of study (screening, baseline, Day 141, Day 225, Day 309, Study Completion)

    To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies

  5. eGFR - Part II

    Time frame: Day 1, Day 29, Day 337,

    Renal function as assessed by MDRD (Modification of Diet in Renal Disease) formula.

    eGFR: Estimated glomerular filtration rate

  6. CFZ533 Plasma PK Concentrations - Part II

    Time frame: throughout study period (day 84 to day 336)

    Quantify the systemic concentrations of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods. A full pharmacokinetic analysis can be performed on the concentration-time data to evaluate the impact of renal transplantation on the various medications used in the treatment regimen.

  7. Total sCD40 Plasma Concentrations - Part II

    Time frame: 12 months

    To quantify the change from baseline and recovery of peripheral blood total soluble CD40

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2014
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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