Table 2.
Study schedule of activities
| Schedule of activities | Enrollment |
Month 1 |
Month 2–5 |
Final visit |
||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline visit 1 | Wk 1–visit 2 | Wk2–visit 3 | Wk3–visit 4 | Wk4–visit 5 | Mo 2–visit 6 | Mo 3–visit 7 | Mo 4–visit 8 | Mo 5–visit 9 | Mo 6–visit 10 | |
| Procedures | ||||||||||
| Informed consent | X | X (Follow up Bx | ||||||||
| Chart Review and documentation | ||||||||||
| Physical examination | X | X | ||||||||
| Concomitant medication review | X | X | X | X | X | X | X | |||
| Medical history | X | |||||||||
| Study-specific assessments | ||||||||||
| Anthropometry measures | X | X | X | |||||||
| Adverse Effects/QOL questionnaires | X | X | X | X | X | X | X | |||
| Study Drug | ||||||||||
| Dispensing of 30-day study drugs. | X | X | X | X | X | X | ||||
| Laboratory tests | ||||||||||
| Routine blood test for standard-of-care | ||||||||||
| BMP | X | X | X | X | X | X | X | |||
| CBC | X | X | X | X | X | X | X | |||
| Routine urine studies | ||||||||||
| Urine protein-to-creatinine ratio | X | X | X | X | X | X | X | X | X | X |
| 24-hour urine studies | X | X | X | |||||||
| Safety laboratory tests related to the study | ||||||||||
| Liver function tests | X | X | X | X | ||||||
| Plasma lactate levels | X | X | X | X | X | X | X | |||
| Lipid panel | X | X | X | |||||||
| Hemoglobin A1C | X | X | X | |||||||
| Vitamin B12 | X | X | X | |||||||
| Research Studies | ||||||||||
| Plasma or biomarkers | X | X | X | X | ||||||
| Buffy coat/ PBMC | X | X | X | X | ||||||
| Urine for biomarkers | X | X | X | X | X | X | X | X | X | X |
| Urine pellet mRNA∗∗ | X | X | X | X | X | X | X | X | X | X |
| Research biopsy | X | |||||||||
QOL, quality of life, BMP, basic metabolic panel; CBC, complete blood count; PBMC, peripheral blood mononuclear cells; mRN, messenger RNA.