Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Cardiovascular Diseases Procedure: Nephrectomy

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2029

Group/Cohort Intervention/treatment
Kidney Donors Procedure: Nephrectomy
Unilateral nephrectomy

Control group



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729557


Contacts
Layout table for location contacts
Contact: Kjersti Blom, MD 0047 45850613 kjersbbl@mail.uio.no
Contact: Jon Arne Birkeland, MD, PhD 0047 97746481 uxbion@ous-hf.no

Locations
Layout table for location information
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Jon Arne Birkeland, MD, PhD    0047 977 46 481    uxbion@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
South-Eastern Norway Regional Health Authority
University of Oslo
Investigators
Layout table for investigator information
Principal Investigator: Jon Arne Birkeland, MD, PhD Oslo University Hospital

Layout table for additonal information
Responsible Party: Jon Arne Birkeland, Principal investigator, Medical doctor, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03729557     History of Changes
Other Study ID Numbers: 2016/1961
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jon Arne Birkeland, Oslo University Hospital:
Kidney donor
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases