Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease
Purpose
The goal of the study is to evaluate descriptively the effect of crizanlizumab + standard of care and standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy.
Condition
- Sickle Cell Disease (SCD)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 mg/g (taken as an average of the three screening ACR values to determine eligibility) - Receiving at least 1 standard of care drug(s) for SCD-related CKD: If receiving HU/HC, the patient must have been receiving HU/HC for at least 6 months and on a stable dose for 3 months, and/or an ACE inhibitor and/or ARB for 3 months and on a stable dose for those 3 months. - Hb ≥ 4.0 g/dL, absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L, and platelet count ≥ 75 x 10^9/L - Adequate hepatic function as defined by: - Alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN) - Direct (conjugated) bilirubin ≤ 3.0 x ULN - Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures
Exclusion Criteria
- History of stem cell transplant - Patients with evidence of AKI within 3 months of study entry (can decrease interval to within 6 weeks of study entry only if renal function has returned to pre-AKI values prior to study entry) - Blood pressure > 140/90 mmHg despite treatment - Patients undergoing renal replacement therapy (ie. hemodialysis, peritoneal dialysis, hemofiltration and kidney transplantation) - Received blood products within 30 days of Week 1 Day 1 - Participating in a chronic transfusion program - History of kidney transplant - Patients with hypoalbuminemia - Body mass index of ≥ 35 - Currently receiving or received voxelotor within 6 months of screening - Patient has received crizanlizumab and/or other selectin inhibitor or plans to receive it during the duration of the study. Other protocol-defined inclusion/exclusion criteria may apply
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental crizanlizumab + standard of care |
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. |
|
Active Comparator standard of care |
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment. |
|
More Details
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals