Cardiovascular Remodeling in Living Kidney Donors With Reduced Glomerular Filtration Rate

NCT ID: NCT03729557

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2029-01-01

Brief Summary

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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

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Conditions

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Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Kidney Donors

Nephrectomy

Intervention Type PROCEDURE

Unilateral nephrectomy

Control group

No interventions assigned to this group

Interventions

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Nephrectomy

Unilateral nephrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

• Persons who do not meet the Norwegian donor criteria.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jon Arne Birkeland

Principal investigator, Medical doctor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jon Arne Birkeland, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 38606688 (View on PubMed)

Blom 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.

Reference Type DERIVED
PMID: 31718316 (View on PubMed)

Other Identifiers

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2016/1961

Identifier Type: -

Identifier Source: org_study_id

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