Chronic Kidney DiseaseCR_LSPNCT02745444
Prevention of Acute Kidney Injury - Molecular Mechanisms of Dietary Pre-conditioning in Human
A study testing low-calorie formula diet and protein-restricted diet in people with Chronic Kidney Disease, run by University of Cologne at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- low-calorie formula diet and protein-restricted diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Competent patients
- Planned living kidney transplantation
- Provision of informed consent
- BMI ≥ 18,5 kg/m²
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- low-calorie formula diet, protein-restricted diet
- Keywords
- Living kidney transplantation, Chronic kidney disease, Acute kidney injury
- Medical subject headings
- Renal Insufficiency, Chronic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-calorie formula dietDietary supplement
protein-restricted dietDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| low-calorie formula diet | Other | Donor taking low-calorie formula diet, 50% of basal energy rate, individually calculated with Mifflin-St. Jeor formula. Receives: Dietary Supplement: low-calorie formula diet |
| no diet | No intervention | Donor ingesting food as usual. |
| protein-restricted diet | Other | 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. Receives: Dietary Supplement: protein-restricted diet |
| Normal protein supply | No intervention | Donor taking same dishes as protein-restricted diet group but with customary protein levels, with unchanged calorie supply. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 year upon receipt of the last tissue sample
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.
Measured: up to 2 years upon receipt of the last tissue sample
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.
Measured: up to 2 years upon receipt of the last tissue sample
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.
Measured: up to 2 years upon receipt of the last tissue sample
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.
Measured: up to 1 year upon receipt of the last tissue sample
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.
Measured: up to 2 years upon receipt of the last tissue sample
Secondary outcomes (4)
Change of NGAL in urine
Change of NGAL in urine, marker for kidney damage measured preoperative in donor and receptor.
Measured: Preoperative from donor and receptor; 6h, 12h and 24h after renal transplantation from receptor.
Cystatin C
Marker for kidney damage measured preoperative and daily until Day 7 postoperative in receptor.
Measured: Preoperative and up until 7 days after renal transplantation from receptor.
Occurrence of acute kidney injury
Occurrence of acute kidney injury according to KDIGO I, II, III in receptor.
Measured: 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
Maximum postoperative serum creatinine of receptor during hospital stay.
Measured: Assessed up to approx. 30 days from date of renal transplantation until date of discharge, which is the end of observation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2015
- Primary completion17 May 2019
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volker Burst, University of Cologne
- Investigators
- Volker Burst, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745444
- Sponsor's protocol ID
- CR_LSP
- Acronym
- CR_LSP
- Status last verified
- Sep 2021
- First submitted
- 29 Mar 2016
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Acute Kidney Injury - Molecular Mechanisms of Dietary Pre-conditioning in Human
- ClinicalTrials.gov ID
- NCT02745444
- Acronym / sponsor ID
- CR_LSP / CR_LSP
- Conditions
- Chronic Kidney Disease
- Keywords
- Living kidney transplantation, Chronic kidney disease, Acute kidney injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low-calorie formula diet | Other | Dietary Supplement: low-calorie formula dietDonor taking low-calorie formula diet, 50% of basal energy rate, individually calculated with Mifflin-St. Jeor formula. |
| no diet | No intervention | –Donor ingesting food as usual. |
| protein-restricted diet | Other | Dietary Supplement: protein-restricted dietDonor 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. |
| Normal protein supply | No intervention | –Donor taking same dishes as protein-restricted diet group but with customary protein levels, with unchanged calorie supply. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Competent patients
- Planned living kidney transplantation
- Provision of informed consent
- BMI ≥ 18,5 kg/m²
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-calorie formula diet | Dietary supplement | low-calorie formula diet |
| protein-restricted diet | Dietary supplement | protein-restricted diet |
Primary outcome
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.
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.
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.
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.
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.
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.
4 secondary outcomes
Change of NGAL in urine
Time frame: Preoperative from donor and receptor; 6h, 12h and 24h after renal transplantation from receptor.
Cystatin C
Time frame: Preoperative and up until 7 days after renal transplantation from receptor.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Volker Burst, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-calorie formula diet and protein-restricted diet in people with Chronic Kidney Disease, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of differentially regulated genes on a transcriptomic level (time frame: up to 1 year upon receipt of the last tissue sample). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.