NCT02560558

Bela 8 Week Dosing

Belatacept Immunosuppression Therapy in Post-Transplant Kidney Recipients: Comparison of 4-Week and 8-Week Dosing Intervals

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The current dosing protocol for patients who have undergone a kidney transplant requires that Belatacept be given as an infusion every 4 weeks. The investigator wants to assess if the patients who have been stable for one year after transplant can be safely transitioned to an 8-week Belatacept infusion schedule. Renal function and any episodes of acute rejection will be closely monitored.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-08-29
• Completion: 2019-08-29
• First posted: 2015-09-25
• Last updated: 2020-09-18
• Results posted: 2020-09-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study