Bela 8 Week Dosing

Completed · Phase 4

Conditions studied: Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT02560558

Run by

Emory University

People needed

166

Starts

2015-09-01

Expected to finish

2019-08-29

Last updated by the study team

2020-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult (age ≥18 years currently),
• First-time renal transplant recipients of either living donor or deceased donor,
• who were initiated on belatacept at the time of transplant and
• are at least one year post-transplant and off CNI therapy for at least 6 months.
• Patients at low immunologic risk, defined as
• patients with a first transplant who have a PRA < 50 against class I and class II antigens,
• no DSA (donor-specific antibodies),
• who have not had more than one episode of rejection, and
• no episodes of rejection within the last 6 months prior to enrollment, and
• no rejection with a grade of IIB or above.

You may not qualify if…

• Not first renal transplant, or multi-organ transplant recipient
• History of greater than one episode of biopsy-proven acute rejection, or of rejection of Banff 97 grade IIB or greater, or rejection within the last 6 months.
• Pregnancy (women of childbearing potential must use adequate contraception during study)
• Unwilling to receive all belatacept infusions at the Emory Transplant Center
• Calculated Glomerular Filtration Rate (GFR) less than 35.
• Serum creatinine at enrollment over 30% higher than 3 months (±4 weeks) prior to randomization
• HbA1C greater than 8 at enrollment
• Recent history of significant proteinuria (protein/Cr ratio >1)
• Non-standard belatacept dosing (e.g. dose other than 5 mg belatacept/kg body weight)
• Cellcept dose less than 500 mg po bid.
• Prednisone dose greater than 5mg po qd within 3 months of randomization
• Patients not currently taking prednisone
• Active infection, or antibiotic or antiviral drug therapy within 1 month of randomization
• Evidence of Cytomegalovirus (CMV) viremia or clinical CMV infection within last 3 months.
• Polyomavirus BK PCR (polymerase chain reaction) load greater then 4.3 (copy number greater than 20,0000) within 3 months of randomization
• Known hepatitis B surface antigen-positive or PCR-positive for hepatitis B (testing not required)
• Known HIV (human immunodeficiency virus infection) (testing not required)
• Presence of donor specific antibody by Luminex single antigen assessment, or panel reactivity (PRA) above 50%.
• History of substance abuse or psychiatric disorder not compatible with study adherence and follow up.

Where it is running

• Emory Clinic — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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