Kidney Transplant Failure and RejectionNCT04733131
Long-term Outcomes After Conversion to Belatacept
An observational study of Kidney Transplant Failure and Rejection and Immunosuppression, run by Paris Translational Research Center for Organ Transplantation.
Trial summary
belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Failure and Rejection, Immunosuppression, Graft Loss
- What is being tested?
- Conversion to a belatacept regimen
- Type of treatment
- Injection or infusion
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2004to Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients converted to a belatacept regimen after kidney transplant
Who may be able to join
- Male or Female, over 18 years of age
- Recipient of kidney allograft from a living donor or a deceased donor
Who cannot join
- Graft loss during the first three months post-transplant
- Epstein-Barr virus Seronegative in the belatacept group
About this study
Official title: Long-term Outcomes After Conversion to a Belatacept-based Immunosuppression in Kidney Transplant
belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant have not been yet reported.
Read the detailed description
belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Major studies evaluating belatacept showed that de novo kidney transplant patients treated with belatacept presented an improved renal function with a higher average estimated glomerular filtration rate (eGFR) compared to ciclosporin (CsA) regimen in patients. Conversion to belatacept after transplant seems to be safe even in highly sensitized patients. However, long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant and compared to a matched control group under a CNIs regimen have not been yet reported.
A multicenter cohort of kidney transplant patients, will be use to match patients converted to a belatacept immunosuppressive regimen to a control group under CNIs immunosuppressive regimen.
- Conditions
- Kidney Transplant Failure and Rejection, Immunosuppression, Graft Loss, Drug Effect Prolonged
- Being tested
- Conversion to a belatacept regimen
- Keywords
- belatacept, multicenter study, Long term outcomes
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversion to a belatacept regimenDrug
Also called Nulojix
belatacept intravenous on Days 1, 15, 29, 43, 57 then every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| converted to a belatacept based immunosuppression | Belatacept: infusion on Days 1, 15, 29, 43, 57 then every 28 days. All patients received a background maintenance immunosuppressive regimen of mycophenolate mofetil or mycophenolic acid, with adjunctive corticosteroids, according to their immunosuppressive regimen at the time of enrollment. Receives: Drug: Conversion to a belatacept regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allograft survival after conversion to belatacept
Graft loss is defined as either functional loss or physical loss (nephrectomy). Functional loss is defined as an eGFR< 15 ml/min/1.73m2 or consecutive days of dialysis. For patients who died with a functioning graft, graft survival will be censored at the time of death as a survived or functional graft.
Measured: 5 years
Patient survival after conversion to belatacept
Patient survival after conversion to a belatacept regimen
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Jan 2004
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant Failure and RejectionStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paris Translational Research Center for Organ Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Loupy, MD, PhD, Principal investigator, Paris Translational Research Center for Organ Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733131
- Sponsor's protocol ID
- switch_bela2021
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Divard G, Aubert O, Debiais-Deschamp C, Raynaud M, Goutaudier V, Sablik M, Sayeg C, Legendre C, Obert J, Anglicheau D, Lefaucheur C, Loupy A. Long-Term Outcomes after Conversion to a Belatacept-Based Immunosuppression in Kidney Transplant Recipients. Clin J Am Soc Nephrol. 2024 May 1;19(5):628-637. doi: 10.2215/CJN.0000000000000411. Epub 2024 Feb 22.
PubMed 38265815
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes After Conversion to a Belatacept-based Immunosuppression in Kidney Transplant
- ClinicalTrials.gov ID
- NCT04733131
- Acronym / sponsor ID
- switch_bela2021
- Conditions
- Kidney Transplant Failure and Rejection, Immunosuppression, Graft Loss, Drug Effect Prolonged
- Keywords
- belatacept, multicenter study, Long term outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Paris Translational Research Center for Organ TransplantationUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 1 Feb 2021 (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.
belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant have not been yet reported.
Detailed description
belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Major studies evaluating belatacept showed that de novo kidney transplant patients treated with belatacept presented an improved renal function with a higher average estimated glomerular filtration rate (eGFR) compared to ciclosporin (CsA) regimen in patients. Conversion to belatacept after transplant seems to be safe even in highly sensitized patients. However, long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant and compared to a matched control group under a CNIs regimen have not been yet reported.
A multicenter cohort of kidney transplant patients, will be use to match patients converted to a belatacept immunosuppressive regimen to a control group under CNIs immunosuppressive regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| converted to a belatacept based immunosuppression | – | Drug: Conversion to a belatacept regimenBelatacept: infusion on Days 1, 15, 29, 43, 57 then every 28 days. All patients received a background maintenance immunosuppressive regimen of mycophenolate mofetil or mycophenolic acid, with adjunctive corticosteroids, according to their immunosuppressive regimen at the time of enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients converted to a belatacept regimen after kidney transplant
Key inclusion criteria (2 listed)
- Male or Female, over 18 years of age
- Recipient of kidney allograft from a living donor or a deceased donor
Key exclusion criteria (2 listed)
- Graft loss during the first three months post-transplant
- Epstein-Barr virus Seronegative in the belatacept group
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 |
|---|---|---|
| Conversion to a belatacept regimenAlso: Nulojixbelatacept intravenous on Days 1, 15, 29, 43, 57 then every 28 days. | Drug | converted to a belatacept based immunosuppression |
Primary outcome
Allograft survival after conversion to belatacept
Time frame: 5 years
Graft loss is defined as either functional loss or physical loss (nephrectomy). Functional loss is defined as an eGFR< 15 ml/min/1.73m2 or consecutive days of dialysis. For patients who died with a functioning graft, graft survival will be censored at the time of death as a survived or functional graft.
Patient survival after conversion to belatacept
Time frame: 5 years
Patient survival after conversion to a belatacept regimen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Derived from this study: PubMed 38265815Divard G, Aubert O, Debiais-Deschamp C, Raynaud M, Goutaudier V, Sablik M, Sayeg C, Legendre C, Obert J, Anglicheau D, Lefaucheur C, Loupy A. Long-Term Outcomes after Conversion to a Belatacept-Based Immunosuppression in Kidney Transplant Recipients. Clin J Am Soc Nephrol. 2024 May 1;19(5):628-637. doi: 10.2215/CJN.0000000000000411. Epub 2024 Feb 22.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplant Failure and Rejection
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
Recruiting
Efficiency of Everolimus for the Treatment of Kidney Transplanted Patients Presenting a Missing Self-induced NK-mediated Rejection
Kidney Transplant Failure and Rejection
RecruitingPhase 2
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
Renal Transplant Failure and Rejection
Not yet recruitingPhase 3
Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation
Kidney Transplant Rejection
Active, not recruitingPhase 4
Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients (TRAINING)
Kidney Transplant Failure and Rejection
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.
Alexandre Loupy, MD, PhD principal investigator
Paris Translational Research Center for Organ Transplantation
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Failure and Rejection and Immunosuppression, run by Paris Translational Research Center for Organ Transplantation.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Allograft survival after conversion to belatacept (time frame: 5 years). 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 NCT04733131, 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 1 Feb 2021.