Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT04029402

Conditions

Diabetic Nephropathies

Kidney Disease, Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RNA sequencing

Study Details

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.

Conditions

Diabetic Nephropathies

Kidney Disease, Chronic

Study ID

NCT04029402

Start date

Jul 1, 2019

Status verified date

Apr, 2021

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria (diabetic kidney disease cases):

  • 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)

Exclusion Criteria (diabetic kidney disease cases):

  • less than 3 eGFR values post-biopsy
  • latest recorded eGFR values less than 6 months post-biopsy

Inclusion Criteria (healthy controls):

- at least 1 native kidney disease biopsy with no diagnostic abnormality

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Diabetic kidney disease

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

Healthy controls

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

Interventions

RNA sequencing

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

Primary outcome measure

  • Interstitial fibrosis [ Time Frame: Baseline biopsy ]
  • Glomerulosclerosis [ Time Frame: Baseline biopsy ]
  • Renal function change [ Time Frame: Baseline biopsy ]

Central Contacts and Locations

Central contacts

Richard Gilbert, MD PhD

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

Locations

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Michelle Nash

416-864-6060nashm@smh.ca

More Information

Sponsor

Unity Health Toronto

Last update posted

Apr 30, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2021-04-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.