An observational study in End-stage Renal Disease (ESRD) and Kidney Transplantation, sponsored by Hospices Civils de Lyon. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Hospices Civils de Lyon · Observational
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.
2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.
This study's planned enrollment of 30 is below the median of 120 across 441 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Hospices Civils de Lyon is the lead sponsor of 1,856 studies on the registry; 442 are open to participants now.
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Living-Donor Kidney Transplant Recipients
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Exclusion Criteria:
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.
Other: Fecal samples · Other: Urinary sample · Other: Blood samples · Other: Simplified dietary questionnaire
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 sample collected via indwelling catheter at V3 (day of transplantation).
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 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.
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).
Time frame: 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).
Time frame: 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).
Time frame: From V1 (14 days before transplantation, before immunosuppression) to V4 (3 months post-transplantation)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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