Abstract: SA-PO179
The Safety and Feasibility of Obtaining Research Kidney Tissue from Patients with Diabetes: Transformative Research in Diabetic Nephropathy (TRIDENT Study)
Session Information
- Diabetic Kidney Disease: Clinical - II
October 27, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Diabetic Kidney Disease
- 602 Diabetic Kidney Disease: Clinical
Authors
- Mottl, Amy K., University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
- Susztak, Katalin, University of Pennsylvania, Philadelphia, Pennsylvania, United States
- Hogan, Jonathan J., Hospital of the University of Pennsylvania, Haddonfield, New Jersey, United States
- Canetta, Pietro A., Columbia, New York, New York, United States
- Campbell, Kirk N., Icahn School of Medicine at Mount Sinai, New York, New York, United States
- Kretzler, Matthias, U.Michigan, Ann Arbor, Michigan, United States
- Isakova, Tamara, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, United States
- Argyropoulos, Christos, University of New Mexico, Albuquerque, New Mexico, United States
- Lafayette, Richard A., Stanford University, Stanford, California, United States
- Bansal, Shweta, University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
- Szerlip, Harold M., Baylor University Medical Center , Dallas, Texas, United States
- Almaani, Salem, The Ohio State University, Columbus, Ohio, United States
- Luciano, Randy L., Yale University School of Medicine, New Haven, Connecticut, United States
- Townsend, Raymond R., University of Pennsylvania School of Medicine, Villanova, Pennsylvania, United States
- Devalaraja-Narashimha, Kishor B., Regeneron Pharmaceuticals, Tarrytown, New York, United States
- Cammack, Nick, GSK, Stevenage, United Kingdom
- Blady, Shira, University of Pennsylvania, Philadelphia, Pennsylvania, United States
- Palmer, Matthew, University of Pennsylvania, Philadelphia, Pennsylvania, United States
- Guarnieri, Paolo, Boehringer Ingelheim, Ridgefield, Connecticut, United States
Group or Team Name
- TRIDENT Consortium
Background
There is a paucity of novel or specific therapeutics for diabetic kidney disease (DKD) due, in part, to its pathogenetic heterogeneity and lack of human kidney tissue for direct interrogation. TRIDENT (NCT02986984) is a multicenter consortium aimed at generating a longitudinal observational cohort study of 300 adults with diabetes and kidney tissue available for multi omics characterization of DKD. As part of the study initiation, we determined the safety and feasibility of obtaining research kidney tissue from patients undergoing clinical biopsy.
Methods
Individuals with diabetes, scheduled for clinical kidney biopsy, provided written consent to allow for an extra core of kidney tissue for research purposes. Inclusion criteria included confirmation of diabetic glomerulosclerosis, including superimposed non-DKD. A clinically significant complication was defined as a perinephric hematoma >5cm, drop in hemoglobin >2g/dl, need for transfusion or procedure to halt bleeding or anesthesia related complications leading to prolonged hospital stay.
Results
Recruitment began in JAN 2017. To date, 69 individuals (>70% of those approached) have provided written consent, 56 biopsies performed, 49 research cores obtained; 6 patients excluded due to a lack of diabetic glomerulosclerosis on biopsy. 40 participants met inclusion criteria with 18 instances of superimposed nondiabetic pathology: 12 diagnoses of GN, 2 of AIN, 2 of acute tubular injury, 1 CTIN, and 1 pyelonephritis. The mean age was 54 years (±13) and 15 (38%) were female and 13 (33%) African American. Of the 49 biopsies in which an extra core was obtained, there were 2 clinically significant complications; 1 was a hematoma >5cm and the other was respiratory distress from anesthesia-related aspiration.
Conclusion
These preliminary results indicate that it is safe and feasible to obtain research kidney tissue from patients with diabetes undergoing clinical kidney biopsy. The TRIDENT Study is positioned to generate the molecular profiles necessary to unravel the heterogenous pathways involved in DKD.
Funding
- Commercial Support – Boehringer-Ingelheim, GSK, Regeneron