LONGitudinal Multi-omics Phenotyping of KIDney Function Alteration

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Hendrik Bartolomaeus, MD; Phone Number: +49 30 450 540 464; Email: hendrik.bartolomaeus@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13125
    • Recruiting
    • Experimental and Clinical Research Center
    • Contact: Hendrik Bartolomaeus, MD; Phone Number: +49 30 450 540 464; Email: hendrik.bartolomaeus@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic kidney disease

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Kidney Donor; Defined as a human individual donating a kidney
Kidney Recipient; Defined as a patient suffering from chronic kidney disease being the recipient of a kidney transplant

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Anja Mähler, PhD, Charite University, Berlin, Germany; Principal Investigator: Nicola Wilck, MD, Charite University, Berlin, Germany; Principal Investigator: Hendrik Bartolomaeus, MD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Kidney transplant; Short chain fatty acids; Home sampling; Microbial diversity; Shannon-Index
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: LONGKID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
• IPD Sharing Time Frame: Beginning in 2 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No