LONGitudinal Multi-omics Phenotyping of KIDney Function Alteration

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05570929

Enrollment

Registered

2022-10-07

Start date

2023-02-07

Completion date

2026-11-01

Last updated

2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

Short chain fatty acids, Shannon-Index, Microbial diversity, Home sampling, Kidney transplant

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Contacts

Primary ContactHendrik Bartolomaeus, MD

hendrik.bartolomaeus@charite.de+49 30 450 540 464

Outcome results