Bela 8 Week Dosing

NCT02560558 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00082511
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Kidney Transplantation

Keywords

Immunosuppression; Transplantation Immunology

Outcome Measures

Primary Outcomes (1)

• Mean Estimated Glomerular Filtration Rate (eGFR) at 12 Months From Baseline

  The mean estimated Glomerular Filtration Rate (eGFR) will be calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using serum creatinine measurements and the patient's age, gender, and race. An eGFR below 60 ml/min/1.73 m\^2 indicates lower renal function.

  12 months from baseline

Secondary Outcomes (10)

• Number of Participants With Transplant Rejection at 6 Months and 12 Months Post Baseline

  6 months post baseline, 12 months post baseline

• Number of Subjects With Grade IIA and Lower Rejections at 6 Months and 12 Months Post Baseline

  6 months post baseline, 12 months post baseline

• Number of Subjects With Grade IIB and Higher Rejections at 6 Months and 12 Months Post Baseline

  6 months post baseline, 12 months post baseline

• Number of Deaths at 6 Months and 12 Months Post Baseline

  6 months post baseline, 12 months post baseline

• Number of Subjects That Experienced Graft Loss at 6 Moths and 12 Months Post Baseline

  6 months post baseline, 12 months from baseline

Study Arms (2)

Belatacept 8-weekly

EXPERIMENTAL

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.

Drug: Belatacept

Belatacept 4-weekly

ACTIVE COMPARATOR

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.

Drug: Belatacept

Interventions

Belatacept DRUG

Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.

Also known as: Nulojix

Belatacept 4-weekly; Belatacept 8-weekly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Badell IR, Parsons RF, Karadkhele G, Cristea O, Mead S, Thomas S, Robertson JM, Kim GS, Hanfelt JJ, Pastan SO, Larsen CP. Every 2-month belatacept maintenance therapy in kidney transplant recipients greater than 1-year posttransplant: A randomized, noninferiority trial. Am J Transplant. 2021 Sep;21(9):3066-3076. doi: 10.1111/ajt.16538. Epub 2021 Mar 17.

  PMID: 33583120 DERIVED

MeSH Terms

Interventions

Abatacept

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Results Point of Contact

• Title: Dr. Idelberto Badell
• Organization: Emory University

ibadell@emory.edu

404-712-6562

Study Officials

• Idelberto Badell, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: September 25, 2015
• Study Start: September 1, 2015
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: September 18, 2020
• Results First Posted: September 18, 2020

Record last verified: 2020-09

Locations

US (2)