LONGitudinal Multi-omics Phenotyping of KIDney Function Alteration

Recruiting

• Conditions: Chronic Kidney Diseases

• Registration Number: NCT05570929
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-07
• Study Start: 2023-02-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fecal microbiome taxonomy (Shannon-Index)	Change from Baseline at 24 weeks	Measured by 16S amplicon sequencing

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Experimental and Clinical Research Center; 🇩🇪 Berlin, Germany