Kidney Transplant RejectionMERRLINNCT04736381
Impact of the Microbiota on the Likelihood of Renal Graft Rejection
An observational study of Kidney Transplant Rejection, run by Institut National de la Santé Et de la Recherche Médicale, France at 10 sites in France.
Trial summary
Identification of a bacterial signature in the blood or stool that may be associated with acute rejection in patients treated with Nulojix during their first year of transplant. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Belatacept Injection [Nulojix]
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 10 sitesFrance
- Study dates
- 7 Oct 2021to 9 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 70 patients treated with Simulect as induction, and with Nulojix®, mycophenolic acid and steroids as maintenance therapy during the first year of kidney transplant.
Who may be able to join
- Patients called for a kidney transplant
- Induction therapy with Simulect, maintenance therapy with Nulojix, mycophenolate acid and steroids
- Patient having signed the informed consent
Who cannot join
- Multiple grafts combined or sequential
- Induction therapy with polyclonal antibodies
- HIV or active viral infection such as hepatitis B or C
- Active bacterial infection
- Pregnancy or breastfeeding at time of inclusion
- Patient unable to express their consent
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Nephrologie transplantation CHRU Besançon
Besançon, 25000
Néphrologie, hémodialyse, aphérèses, transplantation rénale
La Tronche, 38700
Nephrologie transplantation CHRU Nantes
Nantes, 44200
Nephrologie transplantation CHU Saint Louis Paris
Paris, 75010
Nephrologie transplantation CHU Pitié Salpetriere Paris
Paris, 75013
Service de néphrologie et transplantation adulte. Hôpital Necker
Paris, 75015
Nephrologie hôpital Henri-Mondor
Paris, 94010 Créteil
Nephrologie transplantation CHRU Poitiers
Poitiers, 86021
Nephrologie transplantation CHRU Toulouse
Toulouse, 31059 Toulouse Cedex 9
Nephrologie transplantation CHRU Tours
Tours, 37044
About this study
Identification of a bacterial signature in the blood or stool that may be associated with acute rejection in patients treated with Nulojix during their first year of transplant.
Read the detailed description
Gut microbiota as well as the signature of the 16S plasma bacterial DNA and bacterial metabolites of patients on the date of transplantation and during the first year after transplantation will be analyzed. The phenotype of the patients' T lymphocytes will be analyzed at the same time. These data will be correlated with the occurrence of acute cell rejection during the first year of transplantation
- Conditions
- Kidney Transplant Rejection
- Being tested
- Belatacept Injection [Nulojix]
- Keywords
- Microbiota, Belatacept, Second signal inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belatacept Injection [Nulojix]Drug
Also called Simulect, Mycophenolate mofetil, Steroid
Drugs administrated are part of the usual care
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplanted patients treated with Nulojix | Patients treated with Simulect as induction, and with Nulojix®, mycophenolic acid and steroids as maintenance therapy during the first year of kidney transplant. Receives: Drug: Belatacept Injection [Nulojix] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute rejection occurence
Occurence of cellular rejection according to the BANFF 2017
Measured: 1 year or rejection
Secondary outcomes (3)
Gut and circulating microbiota
16S DNA sequencing
Measured: 1 year or rejection
Lymphocyte phenotype
CD3+CD4+CD57+PD1-, CD3+CD8+CD28low, CD3+CD8+CD45RA phenotype
Measured: 1 year or rejection
Glomerular filtration rate
CDK-EPI creatinine equation
Measured: 1 year or rejection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start7 Oct 2021
- Primary completion8 Apr 2025
- Study completion9 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Antoine Durrbach, MD-PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736381
- Sponsor's protocol ID
- C 19-53
- Acronym
- MERRLIN
- Status last verified
- Jul 2026
- First submitted
- 29 Jan 2021
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vincenti F, Blancho G, Durrbach A, Friend P, Grinyo J, Halloran PF, Klempnauer J, Lang P, Larsen CP, Muhlbacher F, Nashan B, Soulillou JP, Vanrenterghem Y, Wekerle T, Agarwal M, Gujrathi S, Shen J, Shi R, Townsend R, Charpentier B. Five-year safety and efficacy of belatacept in renal transplantation. J Am Soc Nephrol. 2010 Sep;21(9):1587-96. doi: 10.1681/ASN.2009111109. Epub 2010 Jul 15.
PubMed 20634298Durrbach 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 20415898
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Microbiota on the Likelihood of Renal Graft Rejection
- ClinicalTrials.gov ID
- NCT04736381
- Acronym / sponsor ID
- MERRLIN / C 19-53
- Conditions
- Kidney Transplant Rejection
- Keywords
- Microbiota, Belatacept, Second signal inhibitor
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 9 Oct 2026 (estimated)
- First posted
- 3 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.
Identification of a bacterial signature in the blood or stool that may be associated with acute rejection in patients treated with Nulojix during their first year of transplant.
Detailed description
Gut microbiota as well as the signature of the 16S plasma bacterial DNA and bacterial metabolites of patients on the date of transplantation and during the first year after transplantation will be analyzed. The phenotype of the patients' T lymphocytes will be analyzed at the same time. These data will be correlated with the occurrence of acute cell rejection during the first year of transplantation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplanted patients treated with Nulojix | – | Drug: Belatacept Injection [Nulojix]Patients treated with Simulect as induction, and with Nulojix®, mycophenolic acid and steroids as maintenance therapy during the first year of kidney transplant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 70 patients treated with Simulect as induction, and with Nulojix®, mycophenolic acid and steroids as maintenance therapy during the first year of kidney transplant.
Key inclusion criteria (3 listed)
- Patients called for a kidney transplant
- Induction therapy with Simulect, maintenance therapy with Nulojix, mycophenolate acid and steroids
- Patient having signed the informed consent
Key exclusion criteria (6 listed)
- Multiple grafts combined or sequential
- Induction therapy with polyclonal antibodies
- HIV or active viral infection such as hepatitis B or C
- Active bacterial infection
- Pregnancy or breastfeeding at time of inclusion
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 |
|---|---|---|
| Belatacept Injection [Nulojix]Also: Simulect, Mycophenolate mofetil, SteroidDrugs administrated are part of the usual care | Drug | Kidney transplanted patients treated with Nulojix |
Primary outcome
Acute rejection occurence
Time frame: 1 year or rejection
Occurence of cellular rejection according to the BANFF 2017
3 secondary outcomes
Gut and circulating microbiota
Time frame: 1 year or rejection
Lymphocyte phenotype
Time frame: 1 year or rejection
Glomerular filtration rate
Time frame: 1 year or rejection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background: PubMed 20634298Vincenti F, Blancho G, Durrbach A, Friend P, Grinyo J, Halloran PF, Klempnauer J, Lang P, Larsen CP, Muhlbacher F, Nashan B, Soulillou JP, Vanrenterghem Y, Wekerle T, Agarwal M, Gujrathi S, Shen J, Shi R, Townsend R, Charpentier B. Five-year safety and efficacy of belatacept in renal transplantation. J Am Soc Nephrol. 2010 Sep;21(9):1587-96. doi: 10.1681/ASN.2009111109. Epub 2010 Jul 15.
- 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.
- Individual participant dataSharing planned: No
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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.
Antoine Durrbach, MD-PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Rejection, run by Institut National de la Santé Et de la Recherche Médicale, France at 10 sites in France.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Acute rejection occurence (time frame: 1 year or rejection). 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 NCT04736381, which also lists 2 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 3 Aug 2026.