Pathogenesis of Kidney Disease in Type 1 Diabetes: a Modern Kidney Biopsy Cohort (The PANDA Study)

Launched by UNIVERSITY OF COLORADO, DENVER · Apr 1, 2022

Keywords

ClinConnect Summary

The PANDA Study is a clinical trial looking at how kidney disease develops in adults with type 1 diabetes. Up to 40% of people with type 1 diabetes may develop diabetic kidney disease, which can lead to kidney failure and increase the risk of heart problems and early death. This study aims to understand the causes of kidney disease in people with type 1 diabetes today, especially since new technologies like continuous glucose monitoring have improved blood sugar control. Researchers hope to identify factors that can be changed to help prevent kidney disease and improve treatment options.

To participate in this study, you need to be at least 18 years old and have had type 1 diabetes for more than five years. You should also have good blood sugar control, with a specific measure known as HbA1c below 11%. Some people may not be eligible if they have certain other conditions, such as type 2 diabetes, recent severe diabetes complications, or if they are on dialysis. Participants can expect to undergo a kidney biopsy, a procedure that helps doctors look at the kidneys closely to learn more about the disease. Your safety is a top priority, and the study has specific guidelines to ensure that only those who can safely undergo the biopsy are included.

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Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years at enrollment (rationale: this study focuses on determinants of early DKD over the course of T1D in adults)
• • T1D duration \>5 years (rationale: DKD in T1D rarely manifests prior to 5 years of disease duration)
• • HbA1c \<11% (rationale: HbA1c ≥ 11% exceeds the average HbA1c at most academic center and would limiting the generalizability of our study findings)
• Exclusion Criteria:
• • T2D and monogenic diabetes (rationale: our study focuses on T1D)
• • Recent diabetic ketoacidosis, i.e., \<1 month (rationale: safety and insulin resistance and tubular dysfunction of DKA can confound study findings)
• • eGFR \< 30 ml/min/1.73m2 or dialysis treatment (rationale: to reduce the likelihood of identifying secondary pathways that are not specific to kidney injury from T1D)
• • Kidney transplant recipients (rationale: molecular confounding from immunosuppression)
• * Kidney biopsy contraindications (rationale: safety - kidney biopsy):
• • Evidence of bleeding disorder or complications from bleeding
• • Use of aspirin, Nonsteroidal anti-inflammatory drugs (NSAIDS) or other blood thinner that cannot be safely stopped for a sufficient time before and after the biopsy to avoid additional risk of bleeding.
• • INR \> 1.4
• • Hemoglobin (Hgb) \< 10 mg/dL (Colorado) \[altitude\]
• • Hemoglobin (Hgb) \< 9 mg/dL (Washington)
• • Platelet count \< 100,000 / µL
• • Uncontrolled or difficult to control hypertension (\> 150/90 mmHg at the day of biopsy)
• • Single kidney (either by history, documented by prior imaging or ultrasound performed prior to the biopsy)
• • Kidney size: One or both kidneys \< 8 cm
• • Hydronephrosis or other important renal ultrasound findings such as significant stone disease
• • Any evidence of a current urinary tract infection as indicated on day of biopsy
• • Clinical evidence of non-diabetic renal disease
• • Positive urine pregnancy test or pregnancy