Bela 8 Week Dosing

Emory University

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Belatacept

Study type: Interventional

Funder types: Other

Identifiers

NCT02560558

IRB00082511

Details and patient eligibility

About

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.

Full description

The current dosing protocol for patients who have undergone a kidney transplant requires that Belatacept be given as an infusion every 4 weeks. The investigator wants to assess if the patients who have been stable for one year after transplant can be safely transitioned to an 8-week Belatacept infusion schedule. Renal function and any episodes of acute rejection will be closely monitored.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

Belatacept 8-weekly

Experimental group

Description:

Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks.

Treatment:

Drug: Belatacept

Belatacept 4-weekly

Active Comparator group

Description:

Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks.

Treatment:

Drug: Belatacept