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Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients

NCT03663335 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 418

Last updated 2026-03-23

Study results available
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Summary

This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.

Conditions

  • Kidney Transplantation

Interventions

BIOLOGICAL

CFZ533 - Cohort 1/Cohort 2

CFZ533 was administered either by intravenous infusion or subcutaneous injection

DRUG

Mycophenolate Mofetil (MMF)

Per local practice, 250 mg or 500 mg taken orally or 500 mg taken intravenously.

DRUG

Corticosteroids (CS)

Taken either orally or intravenously.

DRUG

Tacrolimus

Standard of care immunosuppressive regimen

DRUG

Induction therapy: basiliximab

Lyophilized solution taken intravenously

DRUG

Induction therapy: rabbit anti-thymocyte globulin (rATG)

Lyophilized vial taken intravenously.

DRUG

Maintenance population: EC-MPS

Tablet that is taken orally

DRUG

Maintenance population: MMF

Tablet that is taken orally

DRUG

Placebo 1 mL

Solution taken subcutaneously and was used for blinding of the CFZ533 doses.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-28
Primary Completion
2021-10-29
Completion
2021-10-29
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Latvia
  • Netherlands
  • Norway
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03663335 on ClinicalTrials.gov