LONGitudinal Multi-omics Phenotyping of KIDney Function Alteration

NCT05570929 | Recruiting

• 1 other identifier: LONGKID
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Fecal microbiome taxonomy (Shannon-Index)

  Measured by 16S amplicon sequencing

  Change from Baseline at 24 weeks

Secondary Outcomes (10)

• Functional capacity of gut microbiota

  Change from Baseline at 24 weeks

• Frequency of circulating T-cell subtypes

  Change from Baseline at 24 weeks

• Serum tryptophan metabolites concentration

  Change from Baseline at 24 weeks

• Serum short-chain fatty acid concentration

  Change from Baseline at 24 weeks

• Fecal tryptophan metabolites concentration

  Change from Baseline at 24 weeks

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic kidney disease

You may qualify if:

• Body-Mass-Index 18,5 - 34,9 kg/m2
• Planned living kidney donation / transplantation

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Experimental and Clinical Research Center

Berlin, 13125, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, urine, stool, and peripheral blood mononuclear cells will be collected.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicola Wilck, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Hendrik Bartolomaeus, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Anja Mähler, PhD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hendrik Bartolomaeus, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 7, 2022
• Study Start: February 7, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning in 2 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

DE (1)