Haematological Disorders
Conditions
Interventions
SEG101 Crizanlizumab
Placebo Comparotor
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion 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
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 • Evidence of CKD attributed to causes other than SCN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the proportion of patients with = 30% decrease in ACR at 12 months compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| This will be supported by a secondary endpoint evaluating the proportion of patients with a = 20% decrease in PCR. | — |
Countries
Ghana, Kenya, South Africa
Contacts
Public ContactClinical Disclosure Officer Clinical Disclosure Officer
Clinical Disclosure Officer
Outcome results
None listed