Analyzing kidney biopsies from diabetic patients
Molecular Analysis of Diabetic Kidney Disease Biopsies
This study is trying to understand the changes in kidney tissue from people with diabetes to find new ways to treat kidney disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 4 sites (Vancouver, British Columbia and 3 other locations) |
| Trial ID | NCT04029402 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the molecular underpinnings of diabetic kidney disease by analyzing archived kidney biopsy tissues from patients with varying degrees of disease progression. Researchers will utilize RNA sequencing to identify transcriptional differences between patients with rapid and slow declines in kidney function, as well as between different histopathological types of kidney damage. The goal is to uncover new molecular pathways that could serve as potential therapeutic targets for diabetic nephropathy. The study will involve collaboration among multiple institutions to gather a substantial number of biopsy samples for analysis.
Who should consider this trial
Good fit: Ideal candidates include individuals with a history of type 1 or type 2 diabetes who have undergone a kidney biopsy showing diabetic kidney disease.
Not a fit: Patients with less than three eGFR values post-biopsy or with very low eGFR values may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of new therapeutic targets for diabetic kidney disease, potentially improving patient outcomes.
How similar studies have performed: Other studies have successfully utilized RNA sequencing to explore kidney diseases, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vancouver, British Columbia and 3 other locations
- 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, Canada (Recruiting)
Study contacts
- Study coordinator: Richard Gilbert, MD PhD
- Email: richard.gilbert@utoronto.ca
- Phone: 416-864-3747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.