Sickle Cell Disease (STEADFAST)
A Phase II, Multicenter, Randomized, Open Label Two Arm Study Comparing the Effect of Crizanlizumab + Standard of Care to Standard of Care Alone on Renal Function in Sickle Cell Disease Patients ≥ 16 Years With Chronic Kidney Disease Due to Sickle Cell Nephropathy.
|This study is recruiting: Phase II||Actual Start Date: [December 10, 2019]||Estimated Completion Date: [September 17, 2022]||Novartis Reference Number: CSEG101A2203|
|Condition: Sickle Cell Disease||Interventions: Crizanlizumab, Standard of Care||Estimated Enrollment: [170 participants]||ClinicalTrials.gov Identifier: NCT04053764|
|This study is recruiting: Phase II||Actual Start Date: [December 10, 2019]|
|Estimated Completion Date: [September 17, 2022]||Novartis Reference Number: CSEG101A2203|
|Condition: Sickle Cell Disease||Interventions: Crizanlizumab, Standard of Care|
|Estimated Enrollment: [170 participants]||ClinicalTrials.gov Identifier: NCT04053764|
The goal of the study is to compare the efficacy and safety of crizanlizumab + standard of care to standard of care alone on renal function in sickle cell disease (SCD) patients ≥ 16 years with chronic kidney disease (CKD) due to sickle cell nephropathy.
Participants may be eligible to participate if they:
- Confirmed diagnosis of SCD (HbSS and HbSβ0-thal SCD genotypes are eligible)
- Have an eGFR ≥ 45 to ≤ 120 mL/min/1.73 m2 based on CKD-EPI formula
- ACR of ≥ 100 to < 2000 mg/g
- Are receiving standard of care drug(s) for SCD and/or CKD for at least 6 months prior to study entry
- Hemoglobin ≥ 4.0 g/dL ANC ≥ 1.0 x 109/L, and platelet count ≥ 75 x 109/L
- Meet other eligibility criteria
- Other protocol-defined inclusion/exclusion criteria may apply
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To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.
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ANC - absolute neutrophil count, CKD - chronic kidney disease, CKD-EPI - chronic kidney disease epidemiology collaboration, eGFR - estimated glomerular filtration rate, ICF - informed consent form, SCD - sickle cell disease
Last Updated: Dec 10, 2019