Abstract: SA-PO541
The Feasibility and Safety of Obtaining Research Kidney Biopsy Cores in Patients with Diabetes: An Interim Analysis of the TRIDENT Study
Session Information
- Diabetic Kidney Disease: Pathology, Epidemiology
November 09, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Diabetic Kidney Disease
- 602 Diabetic Kidney Disease: Clinical
Authors
- Hogan, Jonathan J., Hospital of the University of Pennsylvania, Haddonfield, New Jersey, United States
- Owen, Jonathan G., University of New Mexico, Albuquerque, New Mexico, United States
- Susztak, Katalin, University of Pennsylvania, Philadelphia, Pennsylvania, United States
- Bansal, Shweta, University of Texas Health at San Antonio, San Antonio, Texas, United States
- Szerlip, Harold M., Baylor University Medical Center, Dallas, Texas, United States
- Wadhwani, Shikha, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
- Ross, Michael J., Albert Einstein College of Medicine/ Montefiore Medical Center, Bronx, New York, United States
- Almaani, Salem, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
- Sharma, Deep, Montefiore Medical Center, Old Tappan, New Jersey, United States
- Parikh, Samir M., BIDMC/Harvard Medical School, Boston, Massachusetts, United States
- Avasare, Rupali S., Oregon Health & Science University, Portland, Oregon, United States
- Luciano, Randy L., Yale University School of Medicine, New Haven, Connecticut, United States
- Mottl, Amy K., University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Background
Obtaining additional kidney tissue for research is essential for advancing the understanding and treatment of kidney disease. The Transforming Research in Diabetic Nephropathy (TRIDENT) Study is a multi-center, longitudinal, observational cohort study for adults with diabetes who are undergoing a clinically indicated kidney biopsy, and requires an additional research biopsy core. We present an interim analysis of the feasibility and safety of obtaining research kidney biopsy cores in the TRIDENT study.
Methods
The TRIDENT database was analyzed for data acquired as of May 1, 2019. Data on adverse events (AEs) were obtained for cases where a research core was successfully obtained and a central pathologist confirmed the histologic diagnosis (N=134). Clinical and demographic data was obtained at the enrollment visit, which occurred within 45 days of biopsy. We defined AEs as hematoma >5cm, gross hematuria and prolonged hospital stay. Serious AEs included unplanned blood transfusion, transfer to an intensive care unit (ICU), respiratory distress requiring intubation or vascular radiology intervention to halt bleeding.
Results
As of May 1, 2019, 160 patients were consented and underwent kidney biopsy at 15 centers, with a research biopsy core successfully obtained in 143 cases (89%). Diabetic glomerulopathy was found in 110 (82%) of cases. Patients had a mean age of 54.7 (SD 12.6) years, with 45% female, 32% African American race and 34% Hispanic ethnicity. The mean serum creatinine was 2.9 (SD 1.9) mg/dL. A 16 gauge needle was used in 72 (54%) of biopsies and the mean number of biopsy passes was 3.6 (SD 1.0). Serious AEs occurred in 4 patients (3%): blood transfusion in 2 (1.5%), post-biopsy aspiration leading to respiratory failure and prolonged hospitalization in 1 (0.7%)) and ICU observation in 1 (0.7%). Post-biopsy hematoma >5 cm was noted in 7 (5.2%), 2 developed transient gross hematuria (1.5%) and 5 (3.7%) patients required a prolonged hospital stay.
Conclusion
This interim analysis of the TRIDENT study suggests that obtaining tissue for research purposes in adults with diabetes undergoing clinical kidney biopsies is feasible and is associated with an acceptable complication rate.
Funding
- Commercial Support – Boeringer Ingelheim, Gilead, GSK, Regeneron Pharmaceuticals