NCT02134288

Belatacept for Renal Transplant Recipients With Delayed Graft Function

Prospective, Randomized Trial of Belatacept Switch in Renal Transplant Recipients With Delayed Graft Function

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Currently looking for individuals that have received a kidney transplant, are experiencing delayed graft function (DGF), and meet the criteria for study participation.

Detailed description

Patients who undergo kidney transplantation require long term immunosuppressive therapy (therapy that reduces your body's ability to respond to anything foreign) to prevent damage to the graft, and some experience delayed graft function (DGF, a condition in which the transplanted kidney does not function properly) after transplantation. This study is being conducted to determine if kidney transplant recipients with delayed graft function (DGF) who are switched to the immunosuppressive regimen of belatacept with mycophenolate and steroid will recover from delayed graft function (DGF) in less time (which could potentially lower the risk of rejection associated with delayed graft function) than kidney transplant recipients with delayed graft function (DGF) who remain on the current standard immunosuppressive regimen (standard of care).

Conditions

• Delayed Graft Function

Interventions

Type	Name	Description
DRUG	Belatacept
DRUG	Everolimus

Timeline

• Start date: 2014-04-01
• Primary completion: 2018-12-11
• Completion: 2019-01-18
• First posted: 2014-05-09
• Last updated: 2021-09-23

Locations

1 site across 1 country: United States