Cardiovascular DiseasesCENSNCT03729557
Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate
An observational study of Cardiovascular Diseases, run by Oslo University Hospital at 1 site in Norway.
Trial 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%… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Nephrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 109 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2019to 1 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- Persons who do not meet the Norwegian donor criteria.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Nephrectomy
- Keywords
- Kidney donor
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NephrectomyProcedure or surgery
Unilateral nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Kidney Donors | Not described Receives: Procedure: Nephrectomy | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular mass.
Cardiac magnetic resonance imaging (CMRI) and echocardiography.
Measured: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Change in left ventricular strain.
CMRI and echocardiography.
Measured: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Secondary outcomes (4)
Change in arterial pulse wave velocity.
CMRI
Measured: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Change in intima and media thickness of aorta.
CMRI Inflammation: biomarkers.
Measured: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Change in the calsium/phosphate homeostasis.
DXA-scan.
Measured: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Change in inflammation-marker.
Biomarker: high sensitive CRP
Measured: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start1 Feb 2019
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, University of Oslo
- Responsible party
- Principal investigator, Jon Arne Birkeland, Oslo University Hospital
- Investigators
- Jon Arne Birkeland, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729557
- Sponsor's protocol ID
- 2016/1961
- Acronym
- CENS
- Status last verified
- Aug 2025
- First submitted
- 10 Oct 2018
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brobak KM, Halvorsen LV, Aass HCD, Soraas CL, Aune A, Olsen E, Bergland OU, Rognstad S, Blom KB, Birkeland JAK, Hoieggen A, Larstorp ACK, Solbu MD. Novel biomarkers in patients with uncontrolled hypertension with and without kidney damage. Blood Press. 2024 Dec;33(1):2323980. doi: 10.1080/08037051.2024.2323980. Epub 2024 Apr 12.
PubMed 38606688Blom KB, Bergo KK, Espe EKS, Rosseland V, Grotta OJ, Mjoen G, Asberg A, Bergan S, Sanner H, Bergersen TK, Bjornerheim R, Skauby M, Seljeflot I, Waldum-Grevbo B, Dahle DO, Sjaastad I, Birkeland JA. Cardiovascular rEmodelling in living kidNey donorS with reduced glomerular filtration rate: rationale and design of the CENS study. Blood Press. 2020 Apr;29(2):123-134. doi: 10.1080/08037051.2019.1684817. Epub 2019 Nov 13.
PubMed 31718316
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate
- ClinicalTrials.gov ID
- NCT03729557
- Acronym / sponsor ID
- CENS / 2016/1961
- Conditions
- Cardiovascular Diseases
- Keywords
- Kidney donor
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, University of Oslo
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 2 Nov 2018 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney Donors | – | Procedure: Nephrectomy |
| Control group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Persons who do not meet the Norwegian donor criteria.
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 |
|---|---|---|
| NephrectomyUnilateral nephrectomy | Procedure or surgery | Kidney Donors |
Primary outcome
Change in left ventricular mass.
Time frame: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 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 2,5, 5 and 10 years after kidney donation.
CMRI and echocardiography.
4 secondary outcomes
Change in arterial pulse wave velocity.
Time frame: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Change in intima and media thickness of aorta.
Time frame: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Change in the calsium/phosphate homeostasis.
Time frame: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Change in inflammation-marker.
Time frame: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Derived from this study: PubMed 38606688Brobak KM, Halvorsen LV, Aass HCD, Soraas CL, Aune A, Olsen E, Bergland OU, Rognstad S, Blom KB, Birkeland JAK, Hoieggen A, Larstorp ACK, Solbu MD. Novel biomarkers in patients with uncontrolled hypertension with and without kidney damage. Blood Press. 2024 Dec;33(1):2323980. doi: 10.1080/08037051.2024.2323980. Epub 2024 Apr 12.
- Derived from this study: PubMed 31718316Blom KB, Bergo KK, Espe EKS, Rosseland V, Grotta OJ, Mjoen G, Asberg A, Bergan S, Sanner H, Bergersen TK, Bjornerheim R, Skauby M, Seljeflot I, Waldum-Grevbo B, Dahle DO, Sjaastad I, Birkeland JA. Cardiovascular rEmodelling in living kidNey donorS with reduced glomerular filtration rate: rationale and design of the CENS study. Blood Press. 2020 Apr;29(2):123-134. doi: 10.1080/08037051.2019.1684817. Epub 2019 Nov 13.
- 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.
Jon Arne Birkeland, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Oslo University Hospital at 1 site in Norway.
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 0 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: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2025. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in left ventricular mass. (time frame: Before kidney donation (between one month and 1 day before surgery), new investigation 2,5, 5 and 10 years after kidney donation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03729557, which also lists 2 linked publications.
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 22 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.