Table 1 Font trial: demographic and clinical features of the subject Cohort
Age at consent | Age at consent | ||
|---|---|---|---|
Overall (N = 21) | <18 years (N = 14) | ≥18 years (N = 7) | |
N (%) or Median (IQR) | N (%) or Median (IQR) | N (%) or Median (IQR) | |
Age at Consent (yr) | 14.7 (13.0, 20.8) | 13.5 (12.8, 14.7) | 28.6 (20.8, 34.0) |
Female | 12 (57.1 %) | 8 (57.1 %) | 4 (57.1 %) |
Race (self-reported) | |||
Black or African American | 4 (19.0 %) | 2 (14.3 %) | 2 (28.6 %) |
White | 12 (57.1 %) | 7 (50.0 %) | 5 (71.4 %) |
More than one race | 1 (4.8 %) | 1 (7.1 %) | |
Unknown | 4 (19.0 %) | 4 (28.6 %) | |
Ethnicity (Self-reported) | 7 (33.3 %) | 6 (42.9 %) | 1 (14.3 %) |
Sitting Systolic BP | 109 (104, 120) | 109 (88.0, 115) | 126 (107, 129) |
Sitting Diastolic BP | 66.0 (60.0, 74.0) | 62.5 (54.0, 71.0) | 74.0 (68.0, 79.0) |
Previous Rx with Cyclosporine | 12 (57.1 %) | 6 (42.9 %) | 6 (85.7 %) |
Cyclosporine Rx: Cumulative Exposure (mos) | 6.00 (5.50, 12.0) | 5.50 (4.00, 12.0) | 6.00 (6.00, 12.0) |
Previous Rx with Tacrolimus | 13 (61.9 %) | 8 (57.1 %) | 5 (71.4 %) |
Tacrolimus Rx: Cumulative Exposure (mos) | 7.00 (4.00, 24.0) | 9.50 (4.00, 31.0) | 6.00 (6.00, 24.0) |
Previous Rx with Mycophenolate | 11 (52.4 %) | 9 (64.3 %) | 2 (28.6 %) |
Mycophenolate Rx: Cumulative Exposure (mos) | 6.00 (4.00, 17.0) | 6.00 (5.00, 12.0) | 9.50 (1.00, 18.0) |
Edema | |||
None | 14 (66.7 %) | 9 (64.3 %) | 5 (71.4 %) |
Pretibial | 6 (28.6 %) | 4 (28.6 %) | 2 (28.6 %) |
Ascites | 1 (4.8 %) | 1 (7.1 %) | 0 (0 %) |
Serum Albumin (g/dL) at Screening | 2.40 (2.10, 3.50) | 2.40 (2.05, 3.60) | 2.50 (2.10, 3.50) |
Total Cholesterol (mg/dL) at Screening | 276 (198, 424) | 297 (163, 452) | 267 (198, 424) |
Up/c at Screening | 4.93 (3.30, 11.5) | 9.28 (3.30, 12.2) | 3.41 (3.23, 4.93) |
Baseline eGFR (ml/min/1.73 m2) | 120 (81.1, 170) | 119 (88.2, 221) | 120 (71.5, 151) |
Duration of Follow up Post Randomization (yr) | 1.63 (1.27, 1.74) | 1.66 (1.48, 2.03) | 1.24 (1.06, 1.70) |