NCT02078193

Efficacy of Belatacept in Reducing DSA

An Exploratory, Open-label, Single Center Study to Assess the Efficacy of NULOJIX (Belatacept) in Reducing Donor Specific Human Leukocyte Antigen (HLA) Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: East Carolina University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to demonstrate that administration of belatacept in maintenance kidney transplant recipients may cause a reduction in Donor Specific HLA Antibody (DSA).

Detailed description

The aim of this study is to evaluate patients converted to belatacept in combination with Mycophenolate Mofetil (MMF) with corticosteroids with respect to their DSA titer. Patients in this study will be converted from their calcineurin inhibitor (CNI) to belatacept from baseline in an attempt to down-modulate antibody production by B-cells. Dosing will be calculated per prescribing information for dosing maintenance phase (5mg per kg every 28 days.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Belatacept	Patients will be converted from their MMF to Belatacept

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2014-03-05
• Last updated: 2017-08-01
• Results posted: 2017-07-06

Locations

1 site across 1 country: United States