Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01560884 | Study to Assess the Safety and the Phosphate Binding Capacity of Renazorb | PHASE1 | COMPLETED | 32 | — | — | Apr 1, 2012 | Sep 1, 2012 | Nov 8, 2013 | 1 | United States |
Efficacy will be evaluated by comparing difference in urine and fecal phosphorous excretion before and after treatment.
| Arm | Type | Description |
|---|---|---|
| Group B | ACTIVE_COMPARATOR | Six subjects will be randomly assigned to receive SPI-014 3000 mg/day dose and 2 subjects to receive placebo |
| Group C | ACTIVE_COMPARATOR | Six subjects will be randomly assigned to receive SPI-014 4500 mg/day dose and 2 subjects to receive placebo |
| Group D | ACTIVE_COMPARATOR | Six subjects will be randomly assigned to receive SPI-014 6000 mg/day dose and 2 subjects to receive placebo |
| Group A | ACTIVE_COMPARATOR | Six subjects will be randomly assigned to receive SPI-014 1500 mg/day dose and 2 subjects to receive placebo |
| Name | Type | Description |
|---|---|---|
| Renazorb 1500 mg/day | DRUG | Six subjects will be randomly assigned to receive SPI-014 1500 mg/day dose and 2 subjects to receive placebo |
| Renazorb 3000 mg/day | DRUG | Six subjects will be randomly assigned to receive SPI-014 3000 mg/day dose and 2 subjects to receive placebo |
| Renazorb 4500 mg/day | DRUG | Six subjects will be randomly assigned to receive SPI-014 4500 mg/day dose and 2 subjects to receive placebo |
| Renazorb 6000 mg/day | DRUG | Six subjects will be randomly assigned to receive SPI-014 6000 mg/day dose and 2 subjects to receive placebo |
Inclusion Criteria: * Healthy male and female volunteers ≥ 18 years of age without history of significant medical disease will be enrolled. Exclusion Criteria: