Table 1.
Participant baseline, demographic, clinical, and laboratory characteristics
| Parameter | ORBCEL-M (n=12) | Placebo (n=4) | P Valuea |
|---|---|---|---|
| Age (yr) | 69 (66–73) | 59 (54–66) | 0.054 |
| Sex (M/F) (n) | 12/0 | 4/0 | — |
| BP | |||
| Systolic (mm Hg) | 137 (128–147) | 139 (129–144) | 0.144 |
| Diastolic (mm Hg) | 70 (66–78) | 79 (72–84) | 0.715 |
| Serum creatinine (mg/dl) | 1.90 (1.78–2.04) | 2.07 (1.80–2.19) | 0.379 |
| eGFR (CKD-EPI) (ml/min per 1.73 m2) | 35.3 (32.4–38.6) | 33.4 (31.9–40.0) | 0.683 |
| eGFR (MDRD) (ml/min per 1.73 m2) | 35.4 (32.6–38.4) | 32.9 (31.2–38.8) | 0.379 |
| mGFR (ml/min per 1.73 m2) | 38.5 (32.4–42.6) | 39.4 (25.5–50.2) | 0.953 |
| HbA1c (mmol/mol) | 54.1 (47.6–66.8) | 56.1 (45.2–65.5) | 0.861 |
| Fasting glucose (mg/dl) | 131 (117–158) | 183 (138–215) | 0.305 |
| Total cholesterol (mg/dl) | 180 (135–201) | 106 (86–166) | 0.101 |
| UACR (mg/g) | 420.5 (289.4–2042.6) | 982.5 (470.8–3860.8) | 0.845 |
| Medication, n (%) | |||
| Antihypertensive medication use | |||
| ACEi | 5 (41.7) | 2 (50) | 1.000 |
| ARB | 4 (33.3) | 1 (25) | 1.000 |
| β-blocker | 6 (50) | 1 (25) | 0.585 |
| Calcium channel blockers | 6 (50) | 1 (25) | 0.585 |
| Diuretics | 5 (41.7) | 1 (25) | 1.000 |
| Metformin | 6 (50) | 2 (50) | 1.000 |
| Insulin | 12 (100) | 4 (100) | — |
| Statin | 9 (75) | 4 (100) | 0.529 |
| SGLT2i | 1 (9.1) | 0 (0) | 1.000 |
Data are median (interquartile range), unless otherwise indicated. eGFR, estimated GFR; CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration; MDRD, Modification of Diet in Renal Disease; mGFR, measured GFR; HbA1c, hemoglobin A1c; UACR, urinary albumin-to-creatinine ratio; ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; SGLT2i, sodium-glucose cotransporter 2 inhibitor.
a
Wilcoxon test or Fisher exact test, as appropriate.