Kidney TransplantationPhase 4NCT02560558
Bela 8 Week Dosing
A Phase 4 study testing Belatacept in people with Kidney Transplantation, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Belatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to 29 Aug 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Emory Clinic
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Transplantation
- Being tested
- Belatacept
- Keywords
- Immunosuppression, Transplantation Immunology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelataceptDrug
Also called Nulojix
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Belatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months from baseline
Secondary outcomes (10)
Number of Participants With Transplant Rejection at 6 Months and 12 Months Post Baseline
The number of occurrences of transplant rejection at 6 months and 12 months from baseline will be recorded.
Measured: 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
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.
Measured: 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
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.
Measured: 6 months post baseline, 12 months post baseline
Number of Deaths at 6 Months and 12 Months Post Baseline
The total number of subject deaths at 12 months from baseline will be recorded.
Measured: 6 months post baseline, 12 months post baseline
Number of Subjects That Experienced Graft Loss at 6 Moths and 12 Months Post Baseline
The total number of subjects who experienced death censored graft loss at 6 months and 12 months from baseline will be recorded.
Measured: 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
The number of subjects who have circulating human leukocyte antigen donor specific antibodies (HLA DSA) at 12 months from baseline will be recorded.
Measured: 6 moths post baseline, 12 months post baseline
Number of Clinic Visits
The number of clinic visits by the subjects at the end of 12 months from baseline will be recorded.
Measured: At 12 months from baseline
Number of Subjects Needing Hospitalizations
The number of subjects who had hospitalizations at the end of 12 months from baseline will be recorded
Measured: At 12 months from baseline
Number of Subjects Needing Transplant Biopsies at 12 Months Post Baseline
The number of subjects needing transplant biopsies at 12 months from baseline will be recorded.
Measured: 12 months post baseline
Cost Analysis
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.
Measured: At 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startSep 2015
- Primary completion29 Aug 2019
- Study completion29 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Idelberto Badell, Emory University
- Investigators
- Idelberto Badell, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560558
- Sponsor's protocol ID
- IRB00082511
- Status last verified
- Sep 2020
- First submitted
- 24 Sep 2015
- Last updated
- 18 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 33583120
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belatacept Immunosuppression Therapy in Post-Transplant Kidney Recipients: Comparison of 4-Week and 8-Week Dosing Intervals
- ClinicalTrials.gov ID
- NCT02560558
- Acronym / sponsor ID
- IRB00082511
- Conditions
- Kidney Transplantation
- Keywords
- Immunosuppression, Transplantation Immunology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Posted 18 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belatacept 8-weekly | Experimental | Drug: BelataceptSubjects 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. |
| Belatacept 4-weekly | Active comparator | Drug: BelataceptSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult (age ≥18 years currently),
- First-time renal transplant recipients of either living donor or deceased donor,
- Patients at low immunologic risk, defined as
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelataceptAlso: NulojixBelatacept 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. | Drug | Belatacept 4-weekly, Belatacept 8-weekly |
Primary outcome
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.
10 secondary outcomes
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 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 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 Deaths at 6 Months and 12 Months Post Baseline
Time frame: 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
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
Number of Clinic Visits
Time frame: At 12 months from baseline
Number of Subjects Needing Hospitalizations
Time frame: At 12 months from baseline
Number of Subjects Needing Transplant Biopsies at 12 Months Post Baseline
Time frame: 12 months post baseline
Cost Analysis
Time frame: At 12 months from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33583120Badell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Idelberto Badell, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Belatacept in people with Kidney Transplantation, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Estimated Glomerular Filtration Rate (eGFR) at 12 Months From Baseline (time frame: 12 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02560558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.