Table 1.
All Patients Who Underwent Biopsy, n=160 | Research Tissue Not Obtained, n=16 | Research Tissue Obtained | |||
---|---|---|---|---|---|
Total, n=144a | Diabetic Glomerulosclerosis Present, n=117 | Diabetic Glomerulosclerosis Absent, n=26 | |||
Demographics | |||||
Women, n (%) | 68 (43%) | 3 (19%) | 65 (45%) | 49 (42%) | 15 (58%) |
Age, mean (SD), yr | 54 (13) | 53 (12) | 54 (13) | 53 (12) | 61 (13) |
Black race, n (%) | 52 (33%) | 8 (50%) | 44 (30%) | 37 (32%) | 7 (27%) |
Hispanic ethnicity, n (%) | 53 (33%) | 3 (19%) | 50 (35%) | 41 (35%) | 9 (35%) |
Indication for biopsy | |||||
Urinary findings | 14 (9%) | 1 (6%) | 13 (9%) | 2 (2%) | 1 (4%) |
Excessive proteinuria | 104 (65%) | 11 (69%) | 93 (65%) | 71 (61%) | 21 (81%) |
Rapid eGFR loss | 39 (24%) | 4 (25%) | 35 (24%) | 32 (27%) | 3 (12%) |
Other indicators of nondiabetic kidney disease | 2 (1%) | 0 (0%) | 2 (1%) | 12 (10%) | 0 (0%) |
Not available | 1 (0.7%) | 0 (0%) | 1 (0.6%) | 0 (0%) | 1 (4%) |
Procedural characteristics | |||||
Needle gauge, n (%) | |||||
16 G | 86 (54%) | 12 (75%) | 74 (51%) | 58 (50%) | 16 (62%) |
17 G | 2 (1%) | 0 (0%) | 2 (1%) | 1 (0.9%) | 0 (0%) |
18 G | 70 (44%) | 4 (25%) | 66 (46%) | 56 (48%) | 10 (38%) |
Not available | 2 (1%) | 0 (0%) | 2 (1%) | 2 (2%) | 0 (0%) |
Mean (SD) number of passes | 3.6 (1.1) | 3.3 (1.5) | 3.6 (1.0) | 3.6 (1.0) | 3.4 (0.8) |
Biopsy operator, n (%) | |||||
Nephrology Fellow | 64 (40%) | 9 (56%) | 55 (38%) | 46 (39%) | 9 (35%) |
Nephrology Attending | 58 (36%) | 5 (31%) | 53 (37%) | 43 (37%) | 10 (38%) |
Nephrology Fellow with Attending takeover | 3 (2%) | 0 (0%) | 3 (2%) | 3 (3%) | 0 (0%) |
Interventional radiologist | 32 (20%) | 2 (13%) | 30 (21%) | 23 (20%) | 6 (23%) |
Physician assistant | 3 (2%) | 0 (0%) | 3 (2%) | 2 (2%) | 1 (4%) |
Biopsy complications | |||||
Hematoma >5 cm, n (%) | 7 (4%) | 1 (6%) | 6 (4%) | 6 (5%) | 0 (0%) |
Gross hematuria, n (%) | 3 (2%) | 0 (0%) | 3 (2%) | 3 (3%) | 0 (0%) |
Hospital stay exceeding the center’s standard practice, n (%) | 6 (4%) | 1 (6%) | 5 (3%) | 3 (3%) | 2 (8%) |
Blood transfusion, n (%) | 3 (2%) | 0 (0%) | 3 (2%) | 2 (2%) | 1 (4%) |
Surgical/radiological intervention, n (%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
One patient had a research core obtained that was placed in formalin and is included in the safety analysis (n=144) but was not eligible to enroll in the study (n=143) because of this protocol deviation.