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Recruiting NCT05570929

LONGitudinal Multi-omics Phenotyping of KIDney Function Alteration

— Observational Chronic Kidney Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Kidney Diseases. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Fecal microbiome taxonomy (Shannon-Index) [Time frame: Change from Baseline at 24 weeks]
Secondary outcome measures (10)
  • Functional capacity of gut microbiota [Time frame: Change from Baseline at 24 weeks]
  • Frequency of circulating T-cell subtypes [Time frame: Change from Baseline at 24 weeks]
  • Serum tryptophan metabolites concentration [Time frame: Change from Baseline at 24 weeks]
  • Serum short-chain fatty acid concentration [Time frame: Change from Baseline at 24 weeks]
  • Fecal tryptophan metabolites concentration [Time frame: Change from Baseline at 24 weeks]
  • Fecal short-chain fatty acid concentration [Time frame: Change from Baseline at 24 weeks]
  • Office systolic blood pressure [Time frame: Change from Baseline at 24 weeks]
  • Office diastolic blood pressure [Time frame: Change from Baseline at 24 weeks]
  • Body fat content [Time frame: Change from Baseline at 24 weeks]
  • Fat free mass [Time frame: Change from Baseline at 24 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Experimental and Clinical Research Center — Berlin

Identifiers

NCT: NCT05570929 · LONGKID

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗