Bela 8 Week Dosing

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02560558
• Date of registration: 24/09/2015
• Prospective Registration: No
• Primary sponsor: Emory University
• Public title: Bela 8 Week Dosing
• Scientific title: Belatacept Immunosuppression Therapy in Post-Transplant Kidney Recipients: Comparison of 4-Week and 8-Week Dosing Intervals
• Date of first enrolment: September 2015
• Target sample size: 166
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02560558
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Idelberto Badell, MD
• Affiliation: Emory University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Kidney Transplantation

Intervention(s)

Drug: Belatacept

Primary Outcome(s)

Mean Estimated Glomerular Filtration Rate (eGFR) at 12 Months From Baseline [Time Frame: 12 months from baseline]

Secondary Outcome(s)

Cost Analysis [Time Frame: At 12 months from baseline]

Number of Clinic Visits [Time Frame: At 12 months from baseline]

Number of Participants With Transplant Rejection at 6 Months and 12 Months Post Baseline [Time Frame: 6 months post baseline, 12 months post baseline]

Number of Subjects Needing Transplant Biopsies at 12 Months Post Baseline [Time Frame: 12 months post baseline]

Number of Subjects With Grade IIA and Lower Rejections at 6 Months and 12 Months Post Baseline [Time Frame: 6 months post baseline, 12 months post baseline]

Number of Deaths at 6 Months and 12 Months Post Baseline [Time Frame: 6 months post baseline, 12 months post baseline]

Number of Subjects Needing Hospitalizations [Time Frame: At 12 months from baseline]

Number of Subjects That Experienced Graft Loss at 6 Moths and 12 Months Post Baseline [Time Frame: 6 months post baseline, 12 months from baseline]

Number of Subjects With Grade IIB and Higher Rejections at 6 Months and 12 Months Post Baseline [Time Frame: 6 months post baseline, 12 months post baseline]

Number of Subjects With Human Leukocyte Antigen Donor Specific Antibodies (HLA DSA) at 6 Months and 12 Months Post Baseline [Time Frame: 6 moths post baseline, 12 months post baseline]

Secondary ID(s)

IRB00082511

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02560558