Bela 8 Week Dosing

September 16, 2020 updated by: Idelberto Badell, Emory University

Belatacept Immunosuppression Therapy in Post-Transplant Kidney Recipients: Comparison of 4-Week and 8-Week Dosing Intervals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30322
        • Emory Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Belatacept 8-weekly
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 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.
Other Names:
  • Nulojix
Active Comparator: Belatacept 4-weekly
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
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.
Other Names:
  • Nulojix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Estimated Glomerular Filtration Rate (eGFR) at 12 Months From Baseline
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Transplant Rejection at 6 Months and 12 Months Post Baseline
Time Frame: 6 months post baseline, 12 months post baseline
The number of occurrences of transplant rejection at 6 months and 12 months from baseline will be recorded.
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
Time Frame: 6 months post baseline, 12 months post baseline
The number of subjects with Grade IIA and lower severity of rejection on the Banff 97 diagnostic categories will be recorded. The severity of acute rejections will be graded based on histopathological findings; Grade IA= significant interstitial infiltration and moderate tubulitis; Grade IB= significant interstitial infiltration and severe tubulitis; Grade IIA= mild to moderate intimal arteritis; Grade IIB= severe intimal arteritis and Grade III= transmural arteritis and/or fibrinoid change and necrosis of cells.
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
Time Frame: 6 months post baseline, 12 months post baseline
The number of subjects with Grade IIB and higher severity of rejection on the Banff 97 diagnostic categories will be recorded. The severity of acute rejections will be graded based on histopathological findings; Grade IA= significant interstitial infiltration and moderate tubulitis; Grade IB= significant interstitial infiltration and severe tubulitis; Grade IIA= mild to moderate intimal arteritis; Grade IIB= severe intimal arteritis and Grade III= transmural arteritis and/or fibrinoid change and necrosis of cells.
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
The total number of subject deaths at 12 months from baseline will be recorded.
6 months post baseline, 12 months post 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
The total number of subjects who experienced death censored graft loss at 6 months and 12 months from baseline will be recorded.
6 months post baseline, 12 months from 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
The number of subjects who have circulating human leukocyte antigen donor specific antibodies (HLA DSA) at 12 months from baseline will be recorded.
6 moths post baseline, 12 months post baseline
Number of Clinic Visits
Time Frame: At 12 months from baseline
The number of clinic visits by the subjects at the end of 12 months from baseline will be recorded.
At 12 months from baseline
Number of Subjects Needing Hospitalizations
Time Frame: At 12 months from baseline
The number of subjects who had hospitalizations at the end of 12 months from baseline will be recorded
At 12 months from baseline
Number of Subjects Needing Transplant Biopsies at 12 Months Post Baseline
Time Frame: 12 months post baseline
The number of subjects needing transplant biopsies at 12 months from baseline will be recorded.
12 months post baseline
Cost Analysis
Time Frame: At 12 months from baseline
The mean total cost of infusions received by each subject and those associated with round trip travel to the Emory Transplant Center (ETC) will be estimated using the distance between the residential addresses of subjects and the ETC.
At 12 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Idelberto Badell, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

August 29, 2019

Study Completion (Actual)

August 29, 2019

Study Registration Dates

First Submitted

September 24, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimate)

September 25, 2015

Study Record Updates

Last Update Posted (Actual)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00082511

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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