Bela 8 Week Dosing

NCT02560558 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2020-09-18

Study results available
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Summary

The purpose of this study is to transition patients who have been stable on Belatacept for one year after kidney transplant from standard 4-week to an investigational 8-week belatacept dosing schedule. The investigators hypothesize that renal function and acute rejection rates will be non-inferior with 8-week belatacept dosing.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Belatacept

Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Idelberto Badell, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-08-29
Completion
2019-08-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02560558 on ClinicalTrials.gov