CCFZ533X2201 - PoC Study in de Novo Renal Transplantation

Novartis Pharmaceuticals59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Kidney Transplantation

Interventions

CFZ533BIOLOGICAL

Tacrolimus (Tac)DRUG

Mycophenolate mofetil (MMF)DRUG

Corticosteroids (CS)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (14)

Novartis Investigative Site

Aurora, Colorado, United States

Novartis Investigative Site

Baltimore, Maryland, United States

Novartis Investigative Site

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Mean Cmax Pharmacokinetic Parameter- Part I

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

Time frame: Day 1

Mean Tmax Pharmacokinetic Parameter - Part I

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

Time frame: Day 1

Mean AUClast Pharmacokinetic Parameter - Part I

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

Time frame: Day 1

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

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.

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

Secondary Outcomes

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

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

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

Free CD40 and Total CD40 on B Cells - Part II

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

Data from ClinicalTrials.gov

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