Bela 8 Week Dosing

• Status: Completed
• Trial end date: 2019-08-29
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Emory University
• Treatments: Abatacept

Criteria

Inclusion Criteria:

• Adult (age ≥18 years currently),

• First-time renal transplant recipients of either living donor or deceased donor,

1. who were initiated on belatacept at the time of transplant and

2. are at least one year post-transplant and off CNI therapy for at least 6 months.

• Patients at low immunologic risk, defined as

1. patients with a first transplant who have a PRA < 50 against class I and class II antigens,

2. no DSA (donor-specific antibodies),

3. who have not had more than one episode of rejection, and

4. no episodes of rejection within the last 6 months prior to enrollment, and

5. no rejection with a grade of IIB or above.

Exclusion Criteria:

• 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.