Precision Medicine Offers Belatacept Monotherapy

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and feasibility of converting patients to Belatacept monotherapy (receiving just one immunosuppression drug), and to see what percentage of those patients can be safely converted to once every 8 week administration of Belatacept. Belatacept has been approved by the Food and Drug Administration (FDA) for kidney transplant recipients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Bristol-Myers Squibb
• Treatments: Abatacept

Criteria

Inclusion Criteria:

• Stable renal function with a GFR ≥ 35 ml/min

• No history of acute rejection

• A spot urine protein creatinine ratio of 0.5 or less

• No DSA

Entry: Biomarker criteria

• Blood kSORT and urine CRM tests that are quiescent at entry and following each drug withdrawal.

• A third biomarker KSPOT will be used to assess if any patients has achieved tolerance.

Eligibility for 8 week Belatacept Administration

• Trough levels of belatacept at 4 weeks of greater than 2 µg/ml

• Trough levels of belatacept at 8 weeks of equal or greater than 1 µg/ml

Exclusion Criteria:

• Patients with < eGFR (35 ml/min)

• History of rejection

• Protein/creatinine rate >0.5

• Presence of DSA