Chronic Kidney Disease Clinical Trial
— CR_LSPOfficial title:
Prevention of Acute Kidney Injury - Molecular Mechanisms of Dietary Pre-conditioning in Human
NCT number | NCT02745444 |
Other study ID # | CR_LSP |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | May 2020 |
Verified date | September 2021 |
Source | University of Cologne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital of Cologne | Cologne |
Lead Sponsor | Collaborator |
---|---|
University of Cologne |
Germany,
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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
Terminated |
NCT04043026 -
The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
|
||
Completed |
NCT05318014 -
Low-protein Formula Supplements in Chronic Kidney Disease
|
N/A | |
Active, not recruiting |
NCT06071065 -
Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients
|
N/A | |
Completed |
NCT02878317 -
Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
|
||
Not yet recruiting |
NCT06039254 -
Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
|
Phase 1 | |
Recruiting |
NCT03160326 -
The QUALITY Vets Project: Muscle Quality and Kidney Disease
|
||
Completed |
NCT02896309 -
The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity
|
N/A | |
Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
Completed |
NCT02875886 -
DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
|
Phase 4 | |
Completed |
NCT02756520 -
Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
|
||
Withdrawn |
NCT02885545 -
The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial
|
Phase 4 | |
Completed |
NCT02836574 -
A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
|
Phase 2 | |
Active, not recruiting |
NCT02483039 -
Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization
|
N/A | |
Completed |
NCT02992548 -
Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
|
Phase 4 | |
Completed |
NCT02369549 -
Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease
|
Phase 3 | |
Terminated |
NCT02543177 -
Optimised Procedure in Patients With NSTEMI and CKD
|
N/A | |
Recruiting |
NCT02205944 -
Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes
|
N/A | |
Active, not recruiting |
NCT02231138 -
Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease
|
Phase 4 |