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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
low-calorie formula diet
protein-restricted diet
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Living kidney transplantation, Chronic kidney disease, Acute kidney injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • University Hospital of Cologne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

No Intervention

Other

No Intervention

Arm Label

low-calorie formula diet

no diet

protein-restricted diet

Normal protein supply

Arm Description

Donor taking low-calorie formula diet, 50% of basal energy rate, individually calculated with Mifflin-St. Jeor formula.

Donor ingesting food as usual.

Donor taking protein-restricted diet according to diet plans of clinical dietetics of University Hospital of Cologne, with unchanged calorie supply, individually calculated with Mifflin-St. Jeor formula.

Donor taking same dishes as protein-restricted diet group but with customary protein levels, with unchanged calorie supply.

Outcomes

Primary Outcome Measures

Number of differentially regulated genes on a transcriptomic level
Identification of relevant difference with regard to transcriptome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Number of differentially regulated genes on a lipidome level
Identification of relevant difference with regard to lipidome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Number of differentially regulated genes on a metabolome level
Identification of relevant difference with regard to metabolome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Number of differentially regulated genes on a epigenome level
Identification of relevant difference with regard to epigenome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Number of differentially regulated genes on a proteome level
Identification of relevant difference with regard to proteome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Number of differentially regulated genes on a phosphoproteome level
Identification of relevant difference with regard to phosphoproteome in kidney tissue between patients with low-calorie diet and and no-diet patients.

Secondary Outcome Measures

Change of NGAL in urine
Change of NGAL in urine, marker for kidney damage measured preoperative in donor and receptor.
Cystatin C
Marker for kidney damage measured preoperative and daily until Day 7 postoperative in receptor.
Occurrence of acute kidney injury
Occurrence of acute kidney injury according to KDIGO I, II, III in receptor.
Maximum postoperative serum creatinine
Maximum postoperative serum creatinine of receptor during hospital stay.

Full Information

First Posted
March 29, 2016
Last Updated
September 28, 2021
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT02745444
Brief Title
Prevention of Acute Kidney Injury - Molecular Mechanisms of Dietary Pre-conditioning in Human
Acronym
CR_LSP
Official Title
Prevention of Acute Kidney Injury - Molecular Mechanisms of Dietary Pre-conditioning in Human
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
May 17, 2019 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Living kidney transplantation, Chronic kidney disease, Acute kidney injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low-calorie formula diet
Arm Type
Other
Arm Description
Donor taking low-calorie formula diet, 50% of basal energy rate, individually calculated with Mifflin-St. Jeor formula.
Arm Title
no diet
Arm Type
No Intervention
Arm Description
Donor ingesting food as usual.
Arm Title
protein-restricted diet
Arm Type
Other
Arm Description
Donor taking protein-restricted diet according to diet plans of clinical dietetics of University Hospital of Cologne, with unchanged calorie supply, individually calculated with Mifflin-St. Jeor formula.
Arm Title
Normal protein supply
Arm Type
No Intervention
Arm Description
Donor taking same dishes as protein-restricted diet group but with customary protein levels, with unchanged calorie supply.
Intervention Type
Dietary Supplement
Intervention Name(s)
low-calorie formula diet
Intervention Type
Dietary Supplement
Intervention Name(s)
protein-restricted diet
Primary Outcome Measure Information:
Title
Number of differentially regulated genes on a transcriptomic level
Description
Identification of relevant difference with regard to transcriptome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Time Frame
up to 1 year upon receipt of the last tissue sample
Title
Number of differentially regulated genes on a lipidome level
Description
Identification of relevant difference with regard to lipidome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Time Frame
up to 2 years upon receipt of the last tissue sample
Title
Number of differentially regulated genes on a metabolome level
Description
Identification of relevant difference with regard to metabolome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Time Frame
up to 2 years upon receipt of the last tissue sample
Title
Number of differentially regulated genes on a epigenome level
Description
Identification of relevant difference with regard to epigenome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Time Frame
up to 2 years upon receipt of the last tissue sample
Title
Number of differentially regulated genes on a proteome level
Description
Identification of relevant difference with regard to proteome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Time Frame
up to 1 year upon receipt of the last tissue sample
Title
Number of differentially regulated genes on a phosphoproteome level
Description
Identification of relevant difference with regard to phosphoproteome in kidney tissue between patients with low-calorie diet and and no-diet patients.
Time Frame
up to 2 years upon receipt of the last tissue sample
Secondary Outcome Measure Information:
Title
Change of NGAL in urine
Description
Change of NGAL in urine, marker for kidney damage measured preoperative in donor and receptor.
Time Frame
Preoperative from donor and receptor; 6h, 12h and 24h after renal transplantation from receptor.
Title
Cystatin C
Description
Marker for kidney damage measured preoperative and daily until Day 7 postoperative in receptor.
Time Frame
Preoperative and up until 7 days after renal transplantation from receptor.
Title
Occurrence of acute kidney injury
Description
Occurrence of acute kidney injury according to KDIGO I, II, III in receptor.
Time Frame
Assessed up to approx. 30 days from date of renal transplantation until date of discharge, which is the end of observation.
Title
Maximum postoperative serum creatinine
Description
Maximum postoperative serum creatinine of receptor during hospital stay.
Time Frame
Assessed up to approx. 30 days from date of renal transplantation until date of discharge, which is the end of observation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Competent patients Planned living kidney transplantation Provision of informed consent BMI ≥ 18,5 kg/m² Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volker Burst, MD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Cologne
City
Cologne
ZIP/Postal Code
50937
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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