SEG101A2203 Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease
- Conditions
- Sickle Cell Disease (SCD)SCD
- Registration Number
- LBCTR2020094586
- Lead Sponsor
- ovartis Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1
Confirmed diagnosis of SCD (HbSS and HbSß0-thal SCD genotypes are eligible)
- Patients with eGFR = 45 to = 120 mL/min/1.73 m2 based on CKD EPI formula
- Patients with ACR of = 100 to < 2000 mg/g
- Receiving standard of care drug(s) for SCD and/or CKD for at least 6 months prior to study entry
- Hb = 4.0 g/dL, absolute neutrophil count (ANC) = 1.0 x 109/L, and platelet count = 75 x 109/L
-Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures
History of stem cell transplant
- Patients with evidence of AKI within 3 months of study entry
- Blood pressure > 140/90 mmHg despite treatment
- Patients undergoing hemodialysis
- Received blood products within 30 days of Week 1 Day 1
- Participating in a chronic transfusion program
- History of kidney transplant
- Patients with hypoalbuminemia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: To evaluate the effect of crizanlizumab + standard of care compared to standard of care alone on albuminuria (ACR) decrease;Timepoints: 12 months;Measure: 12 Months
- Secondary Outcome Measures
Name Time Method