Use of Belatacept in Kidney Transplant PatientsNCT06091995
Use of Belatacept to Delay Tacrolimus Initiation in Kidney Transplant Patients With Delayed Graft Function
An observational study of Use of Belatacept in Kidney Transplant Patients, run by Methodist Health System at 1 site in United States.
Trial summary
Evaluate the impact of one dose of belatacept in patients with Delayed Graft Function(DGF) on their time to renal recovery and corresponding rates of patient and graft survival, rejection, and incidence of BK virus(BKV), Epstein-Barr Virus(EBV) and/or cytomegalovirus (CMV) infections. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Use of Belatacept in Kidney Transplant Patients
- What is being tested?
- impact of administering one dose of belatacept on Estimated Glomerular Filtration Rate(eGFR)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2022to 7 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Age ≥18 years Received living or deceased donor kidney transplant during study period Treatment group: kidney transplant recipients with DGF that received belatacept Control group: kidney transplant recipients with DGF that did not receive belatacept
Who may be able to join
- Age ≥18 years
- Received living or deceased donor kidney transplant during study period
- Documented DGF
Who cannot join
- Multiple organ transplant
- Recipients with acute rejection present on first biopsy evaluation before first belatacept dose
- Recipients with a first dose of belatacept after index discharge or tacrolimus initiation
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Evaluate the impact of one dose of belatacept in patients with Delayed Graft Function(DGF) on their time to renal recovery and corresponding rates of patient and graft survival, rejection, and incidence of BK virus(BKV), Epstein-Barr Virus(EBV) and/or cytomegalovirus (CMV) infections.
Read the detailed description
Evaluate the impact of one dose of belatacept in patients with DGF on their time to renal recovery and corresponding rates of patient and graft survival, rejection, and incidence of BK virus, EBV and/or cytomegalovirus (CMV) infections.
At Methodist Dallas Medical Center(MDMC), while providers may choose to initiate belatacept to delay tacrolimus initiation, the impact of this practice on time to renal recovery has not been evaluated. The purpose of this study is to determine if administering belatacept to delay initiation of tacrolimus shortens time to renal recovery in DGF patients
- Being tested
- impact of administering one dose of belatacept on Estimated Glomerular Filtration Rate(eGFR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impact of administering one dose of belatacept on Estimated Glomerular Filtration Rate(eGFR)Behavioural
Also called impact of administering one dose of belatacept on eGFR
Evaluate the clinical impact of administering one dose of belatacept on eGFR at one-year post-transplant, patient and graft survival outcomes, graft rejection, and incidences of BK virus, EBV and CMV infections.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to renal recovery
weeks 1-4, and months 3, 6, 9 and 12) to capture potential short- and long-term effects on renal function.
Measured: 1 year
post-transplant outcome
Patient survival
- Graft survival Graft rejection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start22 Aug 2022
- Primary completion7 Jul 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Use of Belatacept in Kidney Transplant PatientsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Loncharic, PharmD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091995
- Sponsor's protocol ID
- 030.PHA.2022.D
- Status last verified
- Mar 2026
- First submitted
- 6 Jul 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI is committed to disseminate research results in a timely fashion. Sharing of data generated by this project will be carried out through presentation at national scientific meetings and/or publication in open access journals. The PI will also make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Publications
1. Nulojix (belatacept) [package insert]. Princeton, New Jersey: Bristol-Myers Squibb Company; 2014.
Vincenti F, Charpentier B, Vanrenterghem Y, Rostaing L, Bresnahan B, Darji P, Massari P, Mondragon-Ramirez GA, Agarwal M, Di Russo G, Lin CS, Garg P, Larsen CP. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study). Am J Transplant. 2010 Mar;10(3):535-46. doi: 10.1111/j.1600-6143.2009.03005.x.
PubMed 20415897Durrbach A, Pestana JM, Pearson T, Vincenti F, Garcia VD, Campistol J, Rial Mdel C, Florman S, Block A, Di Russo G, Xing J, Garg P, Grinyo J. A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT study). Am J Transplant. 2010 Mar;10(3):547-57. doi: 10.1111/j.1600-6143.2010.03016.x.
PubMed 20415898Jorgenson MR, Descourouez JL, Brady BL, Bowman L, Hammad S, Kaiser TE, Laub MR, Melaragno JI, Park JM, Chandran MM. Alternatives to immediate release tacrolimus in solid organ transplant recipients: When the gold standard is in short supply. Clin Transplant. 2020 Jul;34(7):e13903. doi: 10.1111/ctr.13903. Epub 2020 May 29.
PubMed 32400907de Graav GN, Baan CC, Clahsen-van Groningen MC, Kraaijeveld R, Dieterich M, Verschoor W, von der Thusen JH, Roelen DL, Cadogan M, van de Wetering J, van Rosmalen J, Weimar W, Hesselink DA. A Randomized Controlled Clinical Trial Comparing Belatacept With Tacrolimus After De Novo Kidney Transplantation. Transplantation. 2017 Oct;101(10):2571-2581. doi: 10.1097/TP.0000000000001755.
PubMed 28403127
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Belatacept to Delay Tacrolimus Initiation in Kidney Transplant Patients With Delayed Graft Function
- ClinicalTrials.gov ID
- NCT06091995
- Acronym / sponsor ID
- 030.PHA.2022.D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 7 Jul 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the impact of one dose of belatacept in patients with Delayed Graft Function(DGF) on their time to renal recovery and corresponding rates of patient and graft survival, rejection, and incidence of BK virus(BKV), Epstein-Barr Virus(EBV) and/or cytomegalovirus (CMV) infections.
Detailed description
Evaluate the impact of one dose of belatacept in patients with DGF on their time to renal recovery and corresponding rates of patient and graft survival, rejection, and incidence of BK virus, EBV and/or cytomegalovirus (CMV) infections.
At Methodist Dallas Medical Center(MDMC), while providers may choose to initiate belatacept to delay tacrolimus initiation, the impact of this practice on time to renal recovery has not been evaluated. The purpose of this study is to determine if administering belatacept to delay initiation of tacrolimus shortens time to renal recovery in DGF patients
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Age ≥18 years Received living or deceased donor kidney transplant during study period Treatment group: kidney transplant recipients with DGF that received belatacept Control group: kidney transplant recipients with DGF that did not receive belatacept
Key inclusion criteria (3 listed)
- Age ≥18 years
- Received living or deceased donor kidney transplant during study period
- Documented DGF
Key exclusion criteria (3 listed)
- Multiple organ transplant
- Recipients with acute rejection present on first biopsy evaluation before first belatacept dose
- Recipients with a first dose of belatacept after index discharge or tacrolimus initiation
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 |
|---|---|---|
| impact of administering one dose of belatacept on Estimated Glomerular Filtration Rate(eGFR)Also: impact of administering one dose of belatacept on eGFREvaluate the clinical impact of administering one dose of belatacept on eGFR at one-year post-transplant, patient and graft survival outcomes, graft rejection, and incidences of BK virus, EBV and CMV infections. | Behavioural | – |
Primary outcome
Time to renal recovery
Time frame: 1 year
weeks 1-4, and months 3, 6, 9 and 12) to capture potential short- and long-term effects on renal function.
post-transplant outcome
Time frame: 1 year
Patient survival o Graft survival Graft rejection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background1. Nulojix (belatacept) [package insert]. Princeton, New Jersey: Bristol-Myers Squibb Company; 2014.
- Background: PubMed 20415897Vincenti F, Charpentier B, Vanrenterghem Y, Rostaing L, Bresnahan B, Darji P, Massari P, Mondragon-Ramirez GA, Agarwal M, Di Russo G, Lin CS, Garg P, Larsen CP. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study). Am J Transplant. 2010 Mar;10(3):535-46. doi: 10.1111/j.1600-6143.2009.03005.x.
- Background: PubMed 20415898Durrbach A, Pestana JM, Pearson T, Vincenti F, Garcia VD, Campistol J, Rial Mdel C, Florman S, Block A, Di Russo G, Xing J, Garg P, Grinyo J. A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT study). Am J Transplant. 2010 Mar;10(3):547-57. doi: 10.1111/j.1600-6143.2010.03016.x.
- Background: PubMed 32400907Jorgenson MR, Descourouez JL, Brady BL, Bowman L, Hammad S, Kaiser TE, Laub MR, Melaragno JI, Park JM, Chandran MM. Alternatives to immediate release tacrolimus in solid organ transplant recipients: When the gold standard is in short supply. Clin Transplant. 2020 Jul;34(7):e13903. doi: 10.1111/ctr.13903. Epub 2020 May 29.
- Background: PubMed 28403127de Graav GN, Baan CC, Clahsen-van Groningen MC, Kraaijeveld R, Dieterich M, Verschoor W, von der Thusen JH, Roelen DL, Cadogan M, van de Wetering J, van Rosmalen J, Weimar W, Hesselink DA. A Randomized Controlled Clinical Trial Comparing Belatacept With Tacrolimus After De Novo Kidney Transplantation. Transplantation. 2017 Oct;101(10):2571-2581. doi: 10.1097/TP.0000000000001755.
- Individual participant dataSharing planned: Yes. The PI is committed to disseminate research results in a timely fashion. Sharing of data generated by this project will be carried out through presentation at national scientific meetings and/or publication in open access journals. The PI will also make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Related trials for Use of Belatacept in Kidney Transplant Patients
Enrolling by invitation
Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression
Kidney Transplant Immunosuppression
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.
Erin Loncharic, PharmD principal investigator
Methodist Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Use of Belatacept in Kidney Transplant Patients, run by Methodist Health System at 1 site 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 3 inclusion and 3 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to renal recovery (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT06091995, which also lists 5 linked publications.
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 27 Mar 2026.