NCT04029402

Brief Summary

Despite decades of research, the pathogenesis of human diabetic kidney disease remains largely unclear. Our goal is to use archived human kidney biopsy tissue from patients with and with diabetic nephropathy to identify new molecules that drive and/or protect against disease progression. We will use RNA sequencing to identify transcriptomic changes that associate with histologic and functional outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

3.4 years

First QC Date

July 21, 2019

Last Update Submit

April 27, 2021

Conditions

Diabetic NephropathiesKidney Disease, Chronic

Outcome Measures

Primary Outcomes (3)

  • Interstitial fibrosis

    Extent of interstitial fibrosis in kidney biopsy assessed using a semi-quantitative scale on light microscopy of biopsy sections

    Baseline biopsy

  • Glomerulosclerosis

    Extent of glomerulosclerosis in kidney biopsy assessed using a semi-quantitative scale on light microscopy of biopsy sections

    Baseline biopsy

  • Renal function change

    Slope of eGFR decline

    Baseline biopsy

Study Arms (2)

Diabetic kidney disease

Patients with archived biopsies with a pathologic diagnosis of diabetic kidney disease, interstitial fibrosis/tubular atrophy, or nephrosclerosis.

Other: RNA sequencing

Healthy controls

Potential living donors with archived biopsies performed as part of their donor workup and with no diagnostic abnormalities

Other: RNA sequencing

Interventions

RNA sequencingOTHER

Transcriptomic analysis of kidney biopsy tissue, and linking with slope of eGFR decline

Also known as: Histology, Slope of eGFR decline
Diabetic kidney diseaseHealthy controls

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Cases: A group of patients with diabetic kidney disease 2. Controls: A group of healthy control patients

You may qualify if:

  • history of type 1 or type 2 diabetes
  • at least 1 archived native kidney biopsy that demonstrates either pure diabetic kidney disease or features of non-specific vascular disease, including glomerulosclerosis, non-inflammatory vascular disease,
  • sufficient remaining archived kidney biopsy tissue for RNA sequencing (100 um thick tissue section) and histologic analysis (PAS and Masson Trichrome staining)

You may not qualify if:

  • less than 3 eGFR values post-biopsy
  • latest recorded eGFR values less than 6 months post-biopsy
  • \- at least 1 native kidney disease biopsy with no diagnostic abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of British Columbia

Vancouver, British Columbia, Canada

NOT YET RECRUITING

University of Manitoba

Winnipeg, Manitoba, Canada

NOT YET RECRUITING

University of Ottawa

Ottawa, Ontario, Canada

NOT YET RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

MeSH Terms

Conditions

Diabetic NephropathiesRenal Insufficiency, Chronic

Interventions

Sequence Analysis, RNAShadowing Technique, Histology

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sequence AnalysisGenetic TechniquesInvestigative TechniquesStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological Techniques

Central Study Contacts

Richard Gilbert, MD PhD

CONTACT

416-864-3747richard.gilbert@utoronto.ca

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2019

First Posted

July 23, 2019

Study Start

July 1, 2019

Primary Completion

December 1, 2022

Study Completion

December 1, 2025

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)