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

Chronic Kidney Disease Clinical Trial

— CR_LSP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745444
• Other study ID #: CR_LSP
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: May 2020

Study information

• Verified date: September 2021
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2020
• Est. primary completion date: May 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Competent patients

• Planned living kidney transplantation

• Provision of informed consent

• BMI = 18,5 kg/m²

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Acute Kidney Injury
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• low-calorie formula diet

• protein-restricted diet

Locations

Country	Name	City	State
Germany	University Hospital of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 1 year upon receipt of the last tissue sample
Primary	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.	up to 2 years upon receipt of the last tissue sample
Primary	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.	up to 2 years upon receipt of the last tissue sample
Primary	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.	up to 2 years upon receipt of the last tissue sample
Primary	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.	up to 1 year upon receipt of the last tissue sample
Primary	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.	up to 2 years upon receipt of the last tissue sample
Secondary	Change of NGAL in urine	Change of NGAL in urine, marker for kidney damage measured preoperative in donor and receptor.	Preoperative from donor and receptor; 6h, 12h and 24h after renal transplantation from receptor.
Secondary	Cystatin C	Marker for kidney damage measured preoperative and daily until Day 7 postoperative in receptor.	Preoperative and up until 7 days after renal transplantation from receptor.
Secondary	Occurrence of acute kidney injury	Occurrence of acute kidney injury according to KDIGO I, II, III in receptor.	Assessed up to approx. 30 days from date of renal transplantation until date of discharge, which is the end of observation.
Secondary	Maximum postoperative serum creatinine	Maximum postoperative serum creatinine of receptor during hospital stay.	Assessed up to approx. 30 days from date of renal transplantation until date of discharge, which is the end of observation.