Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PINTA 745 · 1 trial · 3 indications
To evaluate the safety, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and pharmacokinetics of PINTA 745 and to evaluate percentage change in LBM relative to baseline at 12 weeks, via dual-energy x-ray absorptiometry(DXA) scans, in the group receiving PINTA 745 at the MTD (or if no MTD is reached, at the recommended phase 2 dose)
| Arm | Type | Description |
|---|---|---|
| PINTA 745 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PINTA 745 | DRUG | PINTA 745 will be administered once weekly by IV infusion. Cohort dose schedules: * 3mg/kg weekly for 12 weeks * 3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks * 6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks |
| Placebo | DRUG | Placebo will be administered once weekly by IV infusion. Cohort dose schedules: * 3mg/kg weekly for 12 weeks * 3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks * 6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks |
Inclusion Criteria: * ESRD patient and on outpatient maintenance hemodialysis for ≥ 6 months * Adequate dialysis with Kt/V ≥ 1.2 on two occasions within 12 weeks of enrollment * Undergoing dialysis at least 3 times per week, on average * Serum albumin ≤ 3.8g/dL within 60 days of enrollment * Able a...