NL-OMON55208
Completed
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 - CSEG101A2203 -STEADFAST
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- sickle cell anemia
- Sponsor
- ovartis
- Enrollment
- 4
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male and female patients \* 16 years on the day that signed informed consent
- •is obtained
- •2\. Confirmed diagnosis of SCD. Homozygous HbS and HbS\*0\-thal SCD genotypes are
- •3\. 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\)
- •4\. ACR of \* 100 to \< 2000 mg/g (taken as an average of the three screening ACR
- •values to determine eligibility)
- •5\. Receiving standard of care drug(s) for SCD and/or CKD.
- •6\. Hb \* 4\.0 g/dL, ANC \* 1\.0 x 109/L, and platelet count \* 75 x 109/L
- •7\. ECOG performance status \* 2\.0
Exclusion Criteria
- •1\. History of stem cell transplant
- •2\. 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)
- •3\. Blood pressure \> 140/90 mmHg despite treatment
- •4\.Patients undergoing renal replacement therapy (i.e. hemodialysis, peritoneal
- •dialysis, hemofiltration and kidney transplantation)
- •5\. Participating in a chronic transfusion program
- •6\. History of kidney transplant
- •7\. Patients with hypoalbuminemia
Outcomes
Primary Outcomes
Not specified
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