LONGitudinal Multi-omics Phenotyping of KIDney Function Alteration

Study Overview
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Brief Summary
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This is a longitudinal observation of kidney function, immune system and gut microbiota before and 24 weeks after a live kidney transplantation conducted in donor and recipient pairs living in the same household. Outcome measures include kidney function, body composition, blood pressure, gut microbiome composition, metabolomics and immune cell states.

Official Title
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Observation of Alterations in Kidney Function, Immune System and Gut Mircobiota After Living Donor Kidney Transplantation

Conditions
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Chronic Kidney Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body-Mass-Index 18,5 - 34,9 kg/m2 Planned living kidney donation / transplantation Exclusion Criteria: Clinically relevant heart, lung, liver, and kidney diseases Postoperative phase Acute infections Vegan diet Change of body weight of more than 10% in the month prior to study entry Known drug or alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney Donor<br>Defined as a human individual donating a kidney | |
| Kidney Recipient<br>Defined as a patient suffering from chronic kidney disease being the recipient of a kidney transplant | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal microbiome taxonomy (Shannon-Index) | Measured by 16S amplicon sequencing | Change from Baseline at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity of gut microbiota | Measured by metagenome sequencing | Change from Baseline at 24 weeks | 
| Frequency of circulating T-cell subtypes | Measured by flow cytometry (%) | Change from Baseline at 24 weeks | 
| Serum tryptophan metabolites concentration | Measured by mass spectrometry | Change from Baseline at 24 weeks | 
| Serum short-chain fatty acid concentration | Measured by mass spectrometry | Change from Baseline at 24 weeks | 
| Fecal tryptophan metabolites concentration | Measured by mass spectrometry | Change from Baseline at 24 weeks | 
| Fecal short-chain fatty acid concentration | Measured by mass spectrometry | Change from Baseline at 24 weeks | 
| Office systolic blood pressure | Mean of five consecutive blood pressure measurements (mmHg) | Change from Baseline at 24 weeks | 
| Office diastolic blood pressure | Mean of five consecutive blood pressure measurements (mmHg) | Change from Baseline at 24 weeks | 
| Body fat content | Measured by bioelectrical impedance analysis (%) | Change from Baseline at 24 weeks | 
| Fat free mass | Measured by bioelectrical impedance analysis (%) | Change from Baseline at 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Short chain fatty acids, Shannon-Index, Microbial diversity, Home sampling, Kidney transplant