End-stage Renal Disease (ESRD)MICRO-KTNCT07893691
Microbiota Changes Related to Outcomes in Kidney Transplantation
An observational study of End-stage Renal Disease (ESRD) and Kidney Transplantation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Chronic kidney disease affects approximately 10% of the world population. End-stage renal disease (ESRD) is associated with immune dysregulation, chronic inflammation, and alteration of the gut and urinary microbiota. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease (ESRD), Kidney Transplantation
- What is being tested?
- Fecal samples, Urinary sample and Blood samples
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2027to 15 Jan 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Living-Donor Kidney Transplant Recipients
Who may be able to join
- Adult patient (18 years of age or older)
- Living-donor kidney transplantation
- Initial triple immunosuppressive maintenance therapy: calcineurin inhibitor (tacrolimus) + purine synthesis inhibitor (mycophenolate mofetil) + steroids
- Women of childbearing age: effective contraception required (required by the transplantation procedure and -immunosuppressive treatment, not by the study protocol itself)
- Able to understand study objectives and risks and to provide dated signed written informed consent
Who cannot join
- Pregnant, parturient, or breastfeeding women
- Persons deprived of liberty by judicial or administrative decision
- Persons receiving psychiatric care or under legal protection (guardianship, curatorship)
- Persons not affiliated with a social security scheme or equivalent
- ABO-incompatible kidney transplantation
- Ongoing immunosuppressive treatment or discontinued less than 3 months ago (conventional treatments) or less than 6 months ago (immunosuppressive immunotherapy)
Show all 10Show fewer
- Antibiotic therapy within 3 weeks before inclusion
- History of bariatric surgery or gastrointestinal tract resection (excluding appendectomy or cholecystectomy performed more than 12 months prior)
- Chronic inflammatory bowel disease
- Currently participating in another interventional study with an exclusion period still in effect and potentially interfering with the present study, per investigator judgment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service de Transplantation, Néphrologie et Immunologie Clinique, Hôpital Edouard Herriot
Lyon, 69003
Dr Xavier CHARMETANT, +33 4 27 85 80 00, xavier.charmetant01@chu-lyon.fr
Xavier CHARMETANT, MD, PhD
About this study
Official title: Microbiota Modifications After Kidney Transplantation: Impact on Immunomodulation and Clinical Outcomes
Chronic kidney disease affects approximately 10% of the world population. End-stage renal disease (ESRD) is associated with immune dysregulation, chronic inflammation, and alteration of the gut and urinary microbiota. Kidney transplantation is the reference treatment for ESRD, but required immunosuppressive therapy further aggravates immune dysregulation and is associated with cardiovascular, metabolic and infectious complications. The gut microbiota plays a central role in modulating systemic immunity. In ESRD, microbiota composition is strongly altered. A recent study showed an association between gut dysbiosis and all-cause mortality in over 1,300 kidney transplant recipients. However, the mechanisms underlying deleterious microbiota modifications in transplant recipients remain poorly understood, particularly the respective roles of immunosuppressive treatment and renal function recovery. The MICRO-KT study hypothesizes that the programmed introduction of immunosuppressive therapy followed by partial or complete correction of ESRD after living-donor kidney transplantation induces quantitative and qualitative modifications of the fecal microbiota, and that specific microbial signatures are associated with clinical and immunological transplant outcomes. This prospective, single-center, longitudinal, interventional, single-arm cohort study will evaluate microbiota dynamics in 30 adult patients before and after living-donor kidney transplantation. Fecal samples are collected at 14 days before transplantation (before immunosuppression), the day before transplantation (after 4 days of immunosuppression), and 3 months post-transplantation. Urinary samples are collected at transplantation. Blood samples (serum, plasma, PBMCs) are collected at 3 timepoints for immunological and metabolomic analyses. The primary endpoint is to describe fecal microbiota beta-diversity dynamics (Bray-Curtis and Jaccard indices at genus level) across three timepoints. Secondary objectives evaluate associations between microbiota composition and clinical outcomes (rejection, infection, survival), immunosuppressant tolerance, drug levels, PBMC immunological profiles, metabolomic signatures, and dietary patterns.
- Being tested
- Fecal samples, Urinary sample, Blood samples, Simplified dietary questionnaire
- Keywords
- gut microbiota, urinary microbiota, kidney transplantation, immunosuppression, tacrolimus, mycophenolate mofetil, dysbiosis, rejection, infection
- Medical subject headings
- Kidney Failure, Chronic, Dysbiosis, Rejection, Psychology, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal samplesOther
Fecal samples collected by patient at home or in hospital using standardized kits at 3 timepoints: V1 (14 days before transplantation, before immunosuppression), V2 (day before transplantation, after 4 days of immunosuppression), and V4 (3 months post-transplantation)
Urinary sampleOther
Urinary sample collected via indwelling catheter at V3 (day of transplantation).
Blood samplesOther
Blood samples (serum 4 mL, plasma 8 mL, PBMCs 24 mL) collected at V1, V2, and V4 for immunological and metabolomic analyses. Microbiota analyzed by shotgun metagenomic sequencing.
Simplified dietary questionnaireOther
Simplified dietary questionnaire administered at V1 (14 days before transplantation), V4 (3-month follow-up visit), and V5 (6-month follow-up visit) to assess major food categories and evaluate their Spearman correlation with fecal microbiota composition and evolution after kidney transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Living-Donor Kidney Transplant Recipients | Adult patients with end-stage renal disease undergoing living-donor kidney transplantation with triple immunosuppressive maintenance therapy (tacrolimus + mycophenolate mofetil + steroids). Patients are followed from 14 days before to 6.5 months post-transplantation. Fecal, urinary, and blood samples are collected at predefined timepoints for gut and urinary microbiota analysis by metagenomic sequencing, PBMC immunological profiling, and metabolomics. Receives: Other: Fecal samples; Other: Urinary sample; Other: Blood samples; Other: Simplified dietary questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fecal Microbiota Beta-Diversity (Bray-Curtis and Jaccard Indices) at the Genus Taxonomic Level
Comparative analysis of fecal microbiota composition using beta-diversity indices (Bray-Curtis and Jaccard) at the genus taxonomic level, determined by shotgun metagenomic sequencing (Illumina NovaSeq). Statistical comparison performed by PERMANOVA (999 permutations). Alpha-diversity indices (Chao1, Shannon) assessed by Wilcoxon test. Differential taxon analysis performed using Maaslin3 (R software).
Measured: From V1 (14 days before transplantation, before immunosuppression) to V2 (day before transplantation, after 4 days of immunosuppression)
Change in Fecal Microbiota Beta-Diversity (Bray-Curtis and Jaccard Indices) at the Genus Taxonomic Level
Comparative analysis of fecal microbiota composition using beta-diversity indices (Bray-Curtis and Jaccard) at the genus taxonomic level, determined by shotgun metagenomic sequencing (Illumina NovaSeq). Statistical comparison performed by PERMANOVA (999 permutations). Alpha-diversity indices (Chao1, Shannon) assessed by Wilcoxon test. Differential taxon analysis performed using Maaslin3 (R software).
Measured: From V2 (day before transplantation, after 4 days of immunosuppression) to V4 (3 months post-transplantation)
Change in Fecal Microbiota Beta-Diversity (Bray-Curtis and Jaccard Indices) at the Genus Taxonomic Level
Comparative analysis of fecal microbiota composition using beta-diversity indices (Bray-Curtis and Jaccard) at the genus taxonomic level, determined by shotgun metagenomic sequencing (Illumina NovaSeq). Statistical comparison performed by PERMANOVA (999 permutations). Alpha-diversity indices (Chao1, Shannon) assessed by Wilcoxon test. Differential taxon analysis performed using Maaslin3 (R software).
Measured: From V1 (14 days before transplantation, before immunosuppression) to V4 (3 months post-transplantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion15 Oct 2028 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier CHARMETANT, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893691
- Sponsor's protocol ID
- 69HCL25_1215
- Acronym
- MICRO-KT
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota Modifications After Kidney Transplantation: Impact on Immunomodulation and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07893691
- Acronym / sponsor ID
- MICRO-KT / 69HCL25_1215
- Keywords
- gut microbiota, urinary microbiota, kidney transplantation, immunosuppression, tacrolimus, mycophenolate mofetil, dysbiosis, rejection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 15 Oct 2028 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 26 Oct 2026 (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.
Chronic kidney disease affects approximately 10% of the world population. End-stage renal disease (ESRD) is associated with immune dysregulation, chronic inflammation, and alteration of the gut and urinary microbiota. Kidney transplantation is the reference treatment for ESRD, but required immunosuppressive therapy further aggravates immune dysregulation and is associated with cardiovascular, metabolic and infectious complications. The gut microbiota plays a central role in modulating systemic immunity. In ESRD, microbiota composition is strongly altered. A recent study showed an association between gut dysbiosis and all-cause mortality in over 1,300 kidney transplant recipients. However, the mechanisms underlying deleterious microbiota modifications in transplant recipients remain poorly understood, particularly the respective roles of immunosuppressive treatment and renal function recovery. The MICRO-KT study hypothesizes that the programmed introduction of immunosuppressive therapy followed by partial or complete correction of ESRD after living-donor kidney transplantation induces quantitative and qualitative modifications of the fecal microbiota, and that specific microbial signatures are associated with clinical and immunological transplant outcomes. This prospective, single-center, longitudinal, interventional, single-arm cohort study will evaluate microbiota dynamics in 30 adult patients before and after living-donor kidney transplantation. Fecal samples are collected at 14 days before transplantation (before immunosuppression), the day before transplantation (after 4 days of immunosuppression), and 3 months post-transplantation. Urinary samples are collected at transplantation. Blood samples (serum, plasma, PBMCs) are collected at 3 timepoints for immunological and metabolomic analyses. The primary endpoint is to describe fecal microbiota beta-diversity dynamics (Bray-Curtis and Jaccard indices at genus level) across three timepoints. Secondary objectives evaluate associations between microbiota composition and clinical outcomes (rejection, infection, survival), immunosuppressant tolerance, drug levels, PBMC immunological profiles, metabolomic signatures, and dietary patterns.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Living-Donor Kidney Transplant Recipients | – | Other: Fecal samples, Other: Urinary sample, Other: Blood samples, Other: Simplified dietary questionnaireAdult patients with end-stage renal disease undergoing living-donor kidney transplantation with triple immunosuppressive maintenance therapy (tacrolimus + mycophenolate mofetil + steroids). Patients are followed from 14 days before to 6.5 months post-transplantation. Fecal, urinary, and blood samples are collected at predefined timepoints for gut and urinary microbiota analysis by metagenomic sequencing, PBMC immunological profiling, and metabolomics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Living-Donor Kidney Transplant Recipients
Key inclusion criteria (5 listed)
- Adult patient (18 years of age or older)
- Living-donor kidney transplantation
- Initial triple immunosuppressive maintenance therapy: calcineurin inhibitor (tacrolimus) + purine synthesis inhibitor (mycophenolate mofetil) + steroids
- Women of childbearing age: effective contraception required (required by the transplantation procedure and -immunosuppressive treatment, not by the study protocol itself)
- Able to understand study objectives and risks and to provide dated signed written informed consent
Key exclusion criteria (10 listed)
- Pregnant, parturient, or breastfeeding women
- Persons deprived of liberty by judicial or administrative decision
- Persons receiving psychiatric care or under legal protection (guardianship, curatorship)
- Persons not affiliated with a social security scheme or equivalent
- ABO-incompatible kidney transplantation
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 |
|---|---|---|
| Fecal samplesFecal samples collected by patient at home or in hospital using standardized kits at 3 timepoints: V1 (14 days before transplantation, before immunosuppression), V2 (day before transplantation, after 4 days of immunosuppression), and V4 (3 months post-transplantation) | Other | Living-Donor Kidney Transplant Recipients |
| Urinary sampleUrinary sample collected via indwelling catheter at V3 (day of transplantation). | Other | Living-Donor Kidney Transplant Recipients |
| Blood samplesBlood samples (serum 4 mL, plasma 8 mL, PBMCs 24 mL) collected at V1, V2, and V4 for immunological and metabolomic analyses. Microbiota analyzed by shotgun metagenomic sequencing. | Other | Living-Donor Kidney Transplant Recipients |
| Simplified dietary questionnaireSimplified dietary questionnaire administered at V1 (14 days before transplantation), V4 (3-month follow-up visit), and V5 (6-month follow-up visit) to assess major food categories and evaluate their Spearman correlation with fecal microbiota composition and evolution after kidney transplantation. | Other | Living-Donor Kidney Transplant Recipients |
Primary outcome
Change in Fecal Microbiota Beta-Diversity (Bray-Curtis and Jaccard Indices) at the Genus Taxonomic Level
Time frame: From V1 (14 days before transplantation, before immunosuppression) to V2 (day before transplantation, after 4 days of immunosuppression)
Comparative analysis of fecal microbiota composition using beta-diversity indices (Bray-Curtis and Jaccard) at the genus taxonomic level, determined by shotgun metagenomic sequencing (Illumina NovaSeq). Statistical comparison performed by PERMANOVA (999 permutations). Alpha-diversity indices (Chao1, Shannon) assessed by Wilcoxon test. Differential taxon analysis performed using Maaslin3 (R software).
Change in Fecal Microbiota Beta-Diversity (Bray-Curtis and Jaccard Indices) at the Genus Taxonomic Level
Time frame: From V2 (day before transplantation, after 4 days of immunosuppression) to V4 (3 months post-transplantation)
Comparative analysis of fecal microbiota composition using beta-diversity indices (Bray-Curtis and Jaccard) at the genus taxonomic level, determined by shotgun metagenomic sequencing (Illumina NovaSeq). Statistical comparison performed by PERMANOVA (999 permutations). Alpha-diversity indices (Chao1, Shannon) assessed by Wilcoxon test. Differential taxon analysis performed using Maaslin3 (R software).
Change in Fecal Microbiota Beta-Diversity (Bray-Curtis and Jaccard Indices) at the Genus Taxonomic Level
Time frame: From V1 (14 days before transplantation, before immunosuppression) to V4 (3 months post-transplantation)
Comparative analysis of fecal microbiota composition using beta-diversity indices (Bray-Curtis and Jaccard) at the genus taxonomic level, determined by shotgun metagenomic sequencing (Illumina NovaSeq). Statistical comparison performed by PERMANOVA (999 permutations). Alpha-diversity indices (Chao1, Shannon) assessed by Wilcoxon test. Differential taxon analysis performed using Maaslin3 (R software).
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 26 Oct 2026.
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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.
Xavier CHARMETANT, MD, PhD principal investigator
Hospices Civils de Lyon
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 End-stage Renal Disease (ESRD) and Kidney Transplantation, run by Hospices Civils de Lyon at 1 site 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 26 Oct 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 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?
Contact Dr Xavier CHARMETANT (+33 4 27 85 80 00, xavier.charmetant01@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fecal Microbiota Beta-Diversity (Bray-Curtis and Jaccard Indices) at the Genus Taxonomic Level (time frame: From V1 (14 days before transplantation, before immunosuppression) to V2 (day before transplantation, after 4 days of immunosuppression)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.