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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01764854 | Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis | PHASE2 | COMPLETED | 88 | — | — | Jan 1, 2013 | Oct 1, 2013 | Aug 10, 2020 | 3 | United States |
Patients are weighed pre dialysis prior to their first dialysis of the week. This measure looks at the change in pre-dialysis weight over time
| Arm | Type | Description |
|---|---|---|
| AZD1722- in patient | EXPERIMENTAL | Tenapanor administered in a clinical pharmacology unit |
| Placebo- in patient | PLACEBO_COMPARATOR | Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit |
| AZD1722 out-patient | EXPERIMENTAL | Tenapanor |
| Placebo out-patient | EXPERIMENTAL | Placebo |
| Name | Type | Description |
|---|---|---|
| AZD1722 (in-patient) | DRUG | doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting |
| Placebo (in-patient) | DRUG | Placebo, size and color matched to experimental drug administered in a CPU |
| AZD1722 (out-patient) | DRUG | doses between 5 and 45 mg BID |
| Placebo | DRUG | Placebo, size and color matched to experimental drug |
Inclusion Criteria: * Males or females aged 18 to 80 years, inclusive; * Body mass index between 18 and 45 kg/m2, inclusive; * Ambulatory (≥ 6 months) maintenance hemodialysis; * Stable dialysis treatment regimen 3x/week for ≥ 2 months prior to screening visit. Exclusion Criteria: * Currently tak...