Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant



Status:Active, not recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:12/9/2017
Start Date:February 29, 2012
End Date:April 30, 2019

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Evaluating Nulojix Long-Term Safety in Transplant

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.

Time Perspective: Prospective for the majority of patients who are enrolled at the time they
begin Nulojix (belatacept) treatment. Retrospective for any patients receiving Nulojix
(belatacept) prior to enrollment into ENLiST Registry

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
We found this trial at
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
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Los Angeles, California 90095
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8700 Beverly Blvd # 8211
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22 Bramhall St
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1 Tampa General Cir
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171 Ashley Avenue
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Charlottesville, Virginia 22908
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251 E Huron St
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Chicago, Illinois 60612
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5841 S Maryland Ave
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Cincinnati, Ohio 45219
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2201 Inwood Rd
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500 University Dr
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1428 Madison Ave
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505 Parnassus Ave
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5300 Tallman Ave NW
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759 Chestnut Street
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