| Novartis Pharmaceuticals | |
| +41613241111 | |
| [email protected] |
| Novartis Pharmaceuticals | |
| 1-888-669-6682 | |
| [email protected] |
6 United States sites
5 Brazil sites
3 Italy sites
3 Spain sites
3 Turkey sites
2 France sites
2 Greece sites
2 United Kingdom sites
1 South Africa site
1 Netherlands site
> 16 Years
HbSS
Phase 2
Interventional
All
Drug
Unknown
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.
– 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
– 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