Detection of Renal Fibrosis and Prediction of Kidney Function Decline

NCT04625140 | Unknown

• 1 other identifier: 2020_161
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the ability of renal MRI to detect fibrosis, how this correlates to renal function and how well renal MRI biomarkers can predict decline in kidney function over time. We will also assess the correlation of renal MRI and kidney function to markers of renal ageing in blood, urine and tissue samples.

Conditions

Kidney Scarring

Keywords

MRI

Outcome Measures

Primary Outcomes (1)

• Correlation of renal fibrosis

  To assess correlations between degree of renal fibrosis determined by a multiparametric MRI protocol and gold-standard morphometric evaluation of renal fibrosis in renal biopsies at baseline (time of scheduled renal biopsy) and after two years (final visit).

  5 years

Secondary Outcomes (3)

• Correlation between renal fibrosis and kidney function

  5 years

• Prediction of kidney function decline

  5 years

• Change in renal function and degree of fibrosis stratifies by disease and use of medication

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for a renal biopsy will have one or more of the following conditions; Reduced kidney function as determined by eGFR (acute or chronic), hematuria, proteinuria, nephrotic syndrome or nephrittic syndrome. Patients with increased risk of complications from a biopsy will likely be excluded (single kidney, bleeding disorder, double anti-platelet therapy, anticoagulant therapy).

You may qualify if:

• \- Patients over 18 years of age, who is scheduled for a kidney biopsy for diagnostic purposes at the Department of Nephrology, Akershus University Hospital will be invited to participate in the study.

You may not qualify if:

• Patients who are not able to understand information in order to give informed consent.
• Patients with claustrophobia.
• Patients with implanted metal devices which are not compatible with MRI.

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Akershus University Hospital

Oslo, Lørenskog, 1478, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and renal biopsy samples will be collected and analyzed for markers of renal ageing and inflammation.

MeSH Terms

Conditions

Glomerulonephritis

Condition Hierarchy (Ancestors)

Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• My Hanna Sofia Svensson, Professor

  University Hospital, Akershus

  STUDY DIRECTOR

Central Study Contacts

Christian Aalborg, M.D.

CONTACT

+4793043516; christian.aalborg@ahus.no

My Hanna Sofia Svensson, Professor

CONTACT

+4550906736; m.h.s.svensson@med.uio.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 12, 2020
• Study Start: February 1, 2021
• Primary Completion: November 24, 2023
• Study Completion: August 30, 2025
• Last Updated: February 6, 2023

Record last verified: 2023-02

Locations

NO (1)