A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based

NCT01820572 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2021-01-05

Study results available
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Summary

The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Tacrolimus

DRUG

Cyclosporine

DRUG

Belatacept

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-27
Primary Completion
2019-10-24
Completion
2019-10-24
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Colombia
  • France
  • Germany
  • Netherlands
  • Norway
  • Sweden
  • Switzerland

Study Locations

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Entities

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 NCT01820572 on ClinicalTrials.gov