Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00007704

Trial Description

start of 1:1-Block title

Title

Prevention of acute renal failure, molecular mechanism of dietary preconditioning in human.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

CR_LSP

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The goal of this clinical trial is to study if and how a seven days lasting diet can reduce renal damage after kidney donation in humans by analyzing patient’s blood and tissue.
In several trials calorie restriction showed a positive influence and it has already been shown to be feasible in humans, but how it works is not known yet.
There is no additional stress than the diet before the operation, because nearly all blood samples and every tissue samples are always taken because of the clinical routine. We do further examination with it and store, what would have been disposed.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Following changes have been conducted after a protocol amendment (Extension proposal at EC Cologne, vote from 06th July 2016):
- Extension by 2 study arms.
The goal of this trial is to study the molecular mechanisms of renal pre-conditioning using a weeklong calorie restriction in humans. We also investigate the protective effect of a preoperative calorie and protein restriction in the donor on the transplant quality in the recipient after transplantation.
Analysation of transcriptome, lipidome, metabolome, epigenome, proteome and phosphoproteome on the basis of tissue samples of the donor, blood cells and -plasma/-serum and furthermore comparison between the groups with and without calorie restriction and also with and without protein restriction.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007704
  •   2015/10/14
  •   [---]*
  •   yes
  •   Approved
  •   15-031, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   N17 -  Acute renal failure
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Donor receives calorie restricted formula diet, 50% of metabolic rate during 7 days prior to surgery, individually generated with Mifflin-St. Jeor formula.
  •   Nutrition ad libitum, accordingly to donor's habits.
  •   Donor taking protein-restricted diet according to diet plans of clinical dietetics of University Hospital of Cologne during 7 days prior to surgery, 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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Analysis of following outcomes from biopsy of donor's kidney:
- Transkriptom
- Lipidom
- Metabolom
- Epigenom
- Proteom
- Phosphoproteom

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Change in NGAL (µg/L) in urine (prior to surgery in donor and recipient; 6h, 12h and 24h after surgery only in recipient)
- Cystatin C (prior to surgery in recipient; daily sampling until the 7th day after surgery only in recipient)
- Occurrence of acute renal failure in accordance with KDIGI I, II, III
- maximum serum creatinine during hospital stay after surgery

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/06/25
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

1. Competent persons > 18 years of age
2. Planned living kidney donation
3. Written informed consent under legal competence
4. BMI > 18.5 kg/m²

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

1. Competent persons < 18 years of age
2. BMI < 18.5 kg/m²

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität zu Köln
    • Albertus-Magnus-Platz
    • 50923  Köln
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universität zu Köln
    • Mr.  Dr.  Volker  Burst 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Köln (AöR) Klinik II für Nephrologie
    • Ms.  Cornelia  Böhme 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Uniklinik Köln
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.