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Completed

NCT Number: NCT02745444

Prevention of Acute Kidney Injury - Molecular Mechanisms of Dietary Pre-conditioning in Human

The key objective of this pilot study is to assess the molecular mechanisms of renal pre-conditioning by a one-week low-calorie diet in humans.

The protective effect of the low-calorie diet and also of the protein-restriction in donor on transplant qualities and functions in receptor will also be investigated.

Analysis of transcriptome, lipidome, metabolome, epigenome, proteome und phosphoproteome through tissue samples as well as blood samples for comparison of low-calorie diet, protein-restriction and no-diet groups.

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Key information

Conditions

Chronic Kidney Disease Acute Kidney Injury 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Cologne

Cologne, 50937, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years
  • Competent patients
  • Planned living kidney transplantation
  • Provision of informed consent
  • BMI ≥ 18,5 kg/m²

Exclusion criteria

  • None

Treatment and study plan

low-calorie formula diet

Dietary Supplement

protein-restricted diet

Dietary Supplement

Primary outcomes

  1. Number of differentially regulated genes on a transcriptomic level

    Time frame: up to 1 year upon receipt of the last tissue sample

    Identification of relevant difference with regard to transcriptome in kidney tissue between patients with low-calorie diet and and no-diet patients.

  2. Number of differentially regulated genes on a lipidome level

    Time frame: up to 2 years upon receipt of the last tissue sample

    Identification of relevant difference with regard to lipidome in kidney tissue between patients with low-calorie diet and and no-diet patients.

  3. Number of differentially regulated genes on a metabolome level

    Time frame: up to 2 years upon receipt of the last tissue sample

    Identification of relevant difference with regard to metabolome in kidney tissue between patients with low-calorie diet and and no-diet patients.

  4. Number of differentially regulated genes on a epigenome level

    Time frame: up to 2 years upon receipt of the last tissue sample

    Identification of relevant difference with regard to epigenome in kidney tissue between patients with low-calorie diet and and no-diet patients.

  5. Number of differentially regulated genes on a proteome level

    Time frame: up to 1 year upon receipt of the last tissue sample

    Identification of relevant difference with regard to proteome in kidney tissue between patients with low-calorie diet and and no-diet patients.

  6. Number of differentially regulated genes on a phosphoproteome level

    Time frame: up to 2 years upon receipt of the last tissue sample

    Identification of relevant difference with regard to phosphoproteome in kidney tissue between patients with low-calorie diet and and no-diet patients.

Secondary outcomes

  1. Change of NGAL in urine

    Time frame: Preoperative from donor and receptor; 6h, 12h and 24h after renal transplantation from receptor.

    Change of NGAL in urine, marker for kidney damage measured preoperative in donor and receptor.

  2. Cystatin C

    Time frame: Preoperative and up until 7 days after renal transplantation from receptor.

    Marker for kidney damage measured preoperative and daily until Day 7 postoperative in receptor.

  3. Occurrence of acute kidney injury

    Time frame: Assessed up to approx. 30 days from date of renal transplantation until date of discharge, which is the end of observation.

    Occurrence of acute kidney injury according to KDIGO I, II, III in receptor.

  4. Maximum postoperative serum creatinine

    Time frame: Assessed up to approx. 30 days from date of renal transplantation until date of discharge, which is the end of observation.

    Maximum postoperative serum creatinine of receptor during hospital stay.

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Acronym: CR_LSP

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Apr 20, 2016
Registry last updated
Sep 29, 2021

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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