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Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate (CENS)

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ClinicalTrials.gov Identifier: NCT03729557
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
South-Eastern Norway Regional Health Authority
University of Oslo
Information provided by (Responsible Party):
Jon Arne Birkeland, Oslo University Hospital

Tracking Information
First Submitted Date October 10, 2018
First Posted Date November 2, 2018
Last Update Posted Date March 13, 2019
Actual Study Start Date February 1, 2019
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 1, 2018)
  • Change in left ventricular mass. [ Time Frame: Before kidney donation (between one month and 1 day before surgery), new investigation 1, 2, 5 and 10 years after kidney donation. ]
    Cardiac magnetic resonance imaging (CMRI) and echocardiography.
  • Change in left ventricular strain. [ Time Frame: Before kidney donation (between one month and 1 day before surgery), new investigation 1, 2, 5 and 10 years after kidney donation. ]
    CMRI and echocardiography.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03729557 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 2, 2018)
  • Change in arterial pulse wave velocity. [ Time Frame: Before kidney donation (between one month and 1 day before surgery), new investigation 1, 2, 5 and 10 years after kidney donation. ]
    CMRI
  • Change in intima and media thickness of aorta. [ Time Frame: Before kidney donation (between one month and 1 day before surgery), new investigation 1, 2, 5 and 10 years after kidney donation. ]
    CMRI Inflammation: biomarkers.
  • Change in the calsium/phosphate homeostasis. [ Time Frame: Before kidney donation (between one month and 1 day before surgery), new investigation 1, 2, 5 and 10 years after kidney donation. ]
    DXA-scan.
  • Change in inflammation-marker. [ Time Frame: Before kidney donation (between one month and 1 day before surgery), new investigation 1, 2, 5 and 10 years after kidney donation. ]
    Biomarker: high sensitive CRP
Original Secondary Outcome Measures
 (submitted: November 1, 2018)
  • Change in arterial pulse wave velocity. [ Time Frame: Before kidney donation (between one month and 1 day before surgery), new investigation 1, 2, 5 and 10 years after kidney donation. ]
    CMRI
  • Change in intima and media thickness of aorta. [ Time Frame: Before kidney donation (between one month and 1 day before surgery), new investigation 1, 2, 5 and 10 years after kidney donation. ]
    CMRI Inflammation: biomarkers.
  • Change in the calsium/phosphate homeostasis. [ Time Frame: Before kidney donation (between one month and 1 day before surgery), new investigation 1, 2, 5 and 10 years after kidney donation. ]
    DXA-scan.
  • Change in the calsium/phosphate homeostasis. [ Time Frame: Before kidney donation (between one month and 1 day before surgery), new investigation 1, 2, 5 and 10 years after kidney donation. ]
    Biomarkers: Serum calsium, serum phosphate, serum PTH.
  • Change in inflammation-marker. [ Time Frame: Before kidney donation (between one month and 1 day before surgery), new investigation 1, 2, 5 and 10 years after kidney donation. ]
    Biomarker: high sensitive CRP
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate
Official Title Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate
Brief Summary Chronic kidney disease (CKD) is highly frequent, and patients with advanced CKD are known to have a high risk of developing cardiovascular disease (CVD). However, little is known about the cardiovascular risk in patients with mildly reduced kidney function (reduced glomerular filtration rate, GFR), affecting up to 10% of the general population; and importantly, also affecting living kidney donors. Until recently it has been believed that donating a kidney does not represent any health hazard. However, a recent Norwegian epidemiological study suggested that kidney donors have an increased risk of CVD. The pathogenesis linking reduced kidney function to CVD is not known. Living kidney donors provide a unique model for investigating the mechanisms underlying increased risk of CVD in patients with reduced GFR because living kidney donors are healthy before donation. Thus, the main purpose of the Project is to investigate the mekanismes underlying the development of cardiovascular remodelling induced by a reduction in GFR.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The project is a prospective longitudinal parallel group study including persons selected as living kidney donors according to the Norwegian donor criteria and accepted for surgery at Rikshospitalet, Norway. The donors will be compared to a control group consisting of individuals evaluated for donation, but not found eligible and healthy family members related to donors. The control individuals will be age and sex matched to living kidney donors. Control individuals who accept to participate will go through the same test battery (the Norwegian transplantation protocol for living kidney donors) as living kidney donors and must fulfil these criteria before inclusion as controls.
Condition Cardiovascular Diseases
Intervention Procedure: Nephrectomy
Unilateral nephrectomy
Study Groups/Cohorts
  • Kidney Donors
    Intervention: Procedure: Nephrectomy
  • Control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 1, 2018)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2029
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • Donor Group: persons selected as living kidney donors according to the Norwegian donor criteria and accepted for surgery at Rikshospitalet, Norway
  • Control Group: persons fulfilling the criteria according to the Norwegian transplantation protocol for living kidney donors with one exeption: they do not have to be investigated with CT angiography which is not considered necessary.

Exclusion Criteria:

• Persons who do not meet the Norwegian donor criteria.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Kjersti Blom, MD 0047 45850613 kjersbbl@mail.uio.no
Contact: Jon Arne Birkeland, MD, PhD 0047 97746481 uxbion@ous-hf.no
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03729557
Other Study ID Numbers 2016/1961
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Jon Arne Birkeland, Oslo University Hospital
Study Sponsor Oslo University Hospital
Collaborators
  • South-Eastern Norway Regional Health Authority
  • University of Oslo
Investigators
Principal Investigator: Jon Arne Birkeland, MD, PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date March 2019