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NCT Number: NCT05570929

LONGitudinal Multi-omics Phenotyping of KIDney Function Alteration

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.

Recruiting

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Experimental and Clinical Research Center

Berlin, 13125, Germany

Location status: Recruiting

Location contact

Hendrik Bartolomaeus, MD

CONTACT

[email protected]

+49 30 450 540 464

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fecal microbiome taxonomy (Shannon-Index)

    Time frame: Change from Baseline at 24 weeks

    Measured by 16S amplicon sequencing

Secondary outcomes

  1. Functional capacity of gut microbiota

    Time frame: Change from Baseline at 24 weeks

    Measured by metagenome sequencing

  2. Frequency of circulating T-cell subtypes

    Time frame: Change from Baseline at 24 weeks

    Measured by flow cytometry (%)

  3. Serum tryptophan metabolites concentration

    Time frame: Change from Baseline at 24 weeks

    Measured by mass spectrometry

  4. Serum short-chain fatty acid concentration

    Time frame: Change from Baseline at 24 weeks

    Measured by mass spectrometry

  5. Fecal tryptophan metabolites concentration

    Time frame: Change from Baseline at 24 weeks

    Measured by mass spectrometry

  6. Fecal short-chain fatty acid concentration

    Time frame: Change from Baseline at 24 weeks

    Measured by mass spectrometry

  7. Office systolic blood pressure

    Time frame: Change from Baseline at 24 weeks

    Mean of five consecutive blood pressure measurements (mmHg)

  8. Office diastolic blood pressure

    Time frame: Change from Baseline at 24 weeks

    Mean of five consecutive blood pressure measurements (mmHg)

  9. Body fat content

    Time frame: Change from Baseline at 24 weeks

    Measured by bioelectrical impedance analysis (%)

  10. Fat free mass

    Time frame: Change from Baseline at 24 weeks

    Measured by bioelectrical impedance analysis (%)

Study contacts

Contact information is provided by the study sponsor or research team.

Hendrik Bartolomaeus, MD

CONTACT

[email protected]

+49 30 450 540 464

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 7, 2022
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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