PACTR202006732730001
Recruiting
Phase 2
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 (STEADFAST)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Pharma AG
- Enrollment
- 41
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female patients \= 16 years on the day that signed informed consent is obtained
- •Confirmed diagnosis of SCD by hemoglobin (Hb) electrophoresis or high performance liquid chromatography \[performed locally]. HbSS and HbSß0 thal SCD genotypes are eligible
- •Patients with eGFR \= 45 to \= 120 mL/min/1\.73 m2 based on Chronic Kidney Disease Epidemiology Collaboration formula
- •Patients with ACR of \= 100 to \< 2000 mg/g
- •Receiving standard of care drug(s) for SCD and/or CKD. If receiving hydroxyurea (HU)/hydroxycarbamide (HC), angiotensin converting enzyme (ACE) inhibitor, and/or angiotensin receptor blocker (ARB) (and still with abnormal ACR despite treatment), must have been receiving the drug(s) for at least 6 months prior to study entry and plan to continue taking the drug(s) at the same dose and schedule until the patient has reached the end of the study
- •Hb \= 4\.0 g/dL, absolute neutrophil count \= 1\.0 x 109/L, and platelet count \= 75 x 109/L
- •Patients who are clinically stable and are in a non crisis state
Exclusion Criteria
- •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 (pre\-planned series of transfusions for prophylactic purposes). Transfusions for acute complications are permitted (acute chest syndrome, acute splenic sequestration, acute hepatic sequestration, worsened anemia)
- •History of kidney transplant
- •Patients with hypoalbuminemia
- •Use of therapeutic anticoagulation or antiplatelet therapy (other than aspirin or non steroid anti inflammatory drugs) within the 10 days prior to Week 1 Day 1\. Note: Prophylactic anticoagulant dose is permitted, as per local guidelines
- •Patients with active human immunodeficiency virus, Hepatitis B and Hepatitis C infection
Outcomes
Primary Outcomes
Not specified
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