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CCFZ533X2201 - PoC Study in de Novo Renal Transplantation

NCT02217410 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2021-09-28

Study results available
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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.

Conditions

  • Kidney Transplantation

Interventions

BIOLOGICAL

CFZ533

DRUG

Tacrolimus (Tac)

DRUG

Mycophenolate mofetil (MMF)

DRUG

Corticosteroids (CS)

BIOLOGICAL

anti-IL2 Induction

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-05
Primary Completion
2017-11-29
Completion
2017-11-29

Countries

  • United States
  • Brazil
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

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 NCT02217410 on ClinicalTrials.gov