Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease
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
ClinicalTrials.gov Identifier: NCT04053764
Novartis Reference Number: CSEG101A2203
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
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 patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy.
Interventions
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of SCD (HbSS and HbSβ0-thal SCD genotypes are eligible)
Patients with eGFR ≥ 45 to ≤ 130 (women), ≥ 45 to ≤ 140 (men) mL/min/1.73 m2 based on CKD-EPI formula
Patients with ACR of ≥ 100 to < 2000 mg/g
Receiving at least 1 standard of care drug(s) for SCD-related CKD: 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
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
Blood pressure > 130/80 mmHg despite treatment
Patients undergoing hemodialysis
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
Other protocol-defined inclusion/exclusion criteria may apply
Study Locations
Contacts
Have a question?
Call 1-999-669-6682 or email [email protected]