Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant

• Status: Unknown status
• Trial end date: 2019-04-30
• Target enrollment: 0
• Participant gender: All

Summary

To describe how Nulojix (belatacept) is used and to determine how often Post-Transplant Lymphoproliferative Disorder (PTLD), Central Nervous System (CNS) PTLD and Progressive Multifocal Leukoencephalopathy (PML), rare and serious complications of transplant treatment, occur in patients taking Nulojix (belatacept) in a real-world setting.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Parexel
• Treatments: Abatacept

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Adult kidney transplant recipient (age ≥18 years at time of transplant)

• Kidney-only transplant recipient

• Positive EBV serostatus

a) EBV serostatus negative or unknown included per the investigator discretion

• Received first dose of Nulojix (Belatacept) within ≤ 14 days of renal transplant

• Received first dose of Nulojix (Belatacept) as part of normal clinical care (i.e. not as part of a clinical trial)

Exclusion Criteria:

• Received Nulojix (belatacept) for non kidney transplants

• <18 years of age at time of transplant

• Received first dose of Nulojix (belatacept) as an assigned study drug under a clinical trial protocol

• EBV-serostatus negative or unknown patients, except by investigator decision

• Patient who did not receive Belatacept for de novo treatment

• Recipient of concurrent or extant non-kidney organ transplant

• Received first dose of Nulojix (belatacept) > 14 days after date of renal transplant