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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04053764 | Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease | PHASE2 | COMPLETED | 58 | — | — | Dec 10, 2019 | Mar 20, 2023 | Oct 9, 2024 | 24 | United States, Brazil +9 |
The effect of SEG101 on clinical disease activity was measured by at least 30% decrease in Albumin to Creatinine Ratio (ACR) from baseline to month 12. A reduction from baseline indicates improvement in patients.
| Arm | Type | Description |
|---|---|---|
| crizanlizumab + standard of care | EXPERIMENTAL | 5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment. |
| standard of care | ACTIVE_COMPARATOR | Patients in the standard of care alone arm will continue to receive their usual standard of care treatment. |
| Name | Type | Description |
|---|---|---|
| Crizanlizuamb | DRUG | Crizanlizumab is a concentrate for solution for infusion, i.v. use. Supplied in single use 10 mL vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab |
| Standard of Care | DRUG | HU/HC (hydroxyurea/hydroxycarbamide) and/or ACE (angiotensin-converting enzyme) inhibitors and/or ARBs (angiotensin-receptor blocker) |
Inclusion Criteria: * Confirmed diagnosis of SCD (HbSS and HbSβ0-thal SCD genotypes are eligible) * Patients with eGFR ≥ 45 to ≤ 140 mL/min/1.73 m2 based on CKD EPI formula (patients ≥ 18) or the Creatinine-based "Bedside Schwartz" equation (patients \< 18) * Patients with ACR of ≥ 100 to \< 2000 m...