Impact of the Microbiota on the Likelihood of Renal Graft Rejection (MERRLIN)

April 9, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
      • Besançon, France, 25000
        • Recruiting
        • Nephrologie transplantation CHRU Besançon
        • Contact:
      • La Tronche, France, 38700
        • Recruiting
        • Néphrologie, hémodialyse, aphérèses, transplantation rénale
        • Contact:
      • Nantes, France, 44200
        • Recruiting
        • Nephrologie transplantation CHRU Nantes
        • Contact:
      • Paris, France, 75010
      • Paris, France, 75013
        • Recruiting
        • Nephrologie transplantation CHU Pitié Salpetriere Paris
        • Contact:
      • Paris, France, 94010 Créteil
        • Recruiting
        • Nephrologie hôpital Henri-Mondor
        • Contact:
      • Poitiers, France, 86021
      • Toulouse, France, 31059 Toulouse Cedex 9
      • Tours, France, 37044
        • Recruiting
        • Nephrologie transplantation CHRU Tours
        • Contact:

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Patients called for a kidney transplant
  • Induction therapy with Simulect, maintenance therapy with Nulojix, mycophenolate acid and steroids
  • Patient having signed the informed consent

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Belatacept Injection [Nulojix]
Drugs administrated are part of the usual care
Other Names:
  • Simulect
  • Steroid
  • Mycophenolate mofetil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute rejection occurence
Time Frame: 1 year or rejection
Occurence of cellular rejection according to the BANFF 2017
1 year or rejection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut and circulating microbiota
Time Frame: 1 year or rejection
16S DNA sequencing
1 year or rejection
Lymphocyte phenotype
Time Frame: 1 year or rejection
CD3+CD4+CD57+PD1-, CD3+CD8+CD28low, CD3+CD8+CD45RA phenotype
1 year or rejection
Glomerular filtration rate
Time Frame: 1 year or rejection
CDK-EPI creatinine equation
1 year or rejection

Collaborators and Investigators

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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Antoine Durrbach, MD-PhD, Institut National de la Santé Et de la Recherche Médicale, France

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 (Actual)

October 7, 2021

Primary Completion (Estimated)

January 7, 2027

Study Completion (Estimated)

January 7, 2027

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C 19-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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