LONGitudinal Multi-omics Phenotyping of KIDney Function Alteration

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05570929
• Other study ID #: LONGKID
• Status: Recruiting
• Start date: February 7, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: February 2023
• Source: Charite University, Berlin, Germany
• Contact: Hendrik Bartolomaeus, MD
• Phone: +49 30 450 540 464
• Email: hendrik.bartolomaeus[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Germany	Experimental and Clinical Research Center	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal microbiome taxonomy (Shannon-Index)	Measured by 16S amplicon sequencing	Change from Baseline at 24 weeks
Secondary	Functional capacity of gut microbiota	Measured by metagenome sequencing	Change from Baseline at 24 weeks
Secondary	Frequency of circulating T-cell subtypes	Measured by flow cytometry (%)	Change from Baseline at 24 weeks
Secondary	Serum tryptophan metabolites concentration	Measured by mass spectrometry	Change from Baseline at 24 weeks
Secondary	Serum short-chain fatty acid concentration	Measured by mass spectrometry	Change from Baseline at 24 weeks
Secondary	Fecal tryptophan metabolites concentration	Measured by mass spectrometry	Change from Baseline at 24 weeks
Secondary	Fecal short-chain fatty acid concentration	Measured by mass spectrometry	Change from Baseline at 24 weeks
Secondary	Office systolic blood pressure	Mean of five consecutive blood pressure measurements (mmHg)	Change from Baseline at 24 weeks
Secondary	Office diastolic blood pressure	Mean of five consecutive blood pressure measurements (mmHg)	Change from Baseline at 24 weeks
Secondary	Body fat content	Measured by bioelectrical impedance analysis (%)	Change from Baseline at 24 weeks
Secondary	Fat free mass	Measured by bioelectrical impedance analysis (%)	Change from Baseline at 24 weeks