Clinical Trial
Study Details
Crizanlizumab is a concentrate for solution for infusion, i.v. use. Supplied in single use 10 mL vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab
HU/HC (hydroxyurea/hydroxycarbamide) and/or ACE (angiotensin-converting enzyme) inhibitors and/or ARBs (angiotensin-receptor blocker)
The goal of the study was to evaluate descriptively the effect of crizanlizumab + standard of care and standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy.
Study Overview
Approximately 50 patients were to be randomized 1:1 to receive either crizanlizumab (5 mg/kg) + standard of care or standard of care alone. Patients were stratified at randomization based on chronic kidney disease (CKD) risk category (moderate risk or high/very high risk) and hydroxyurea/hydroxycarbamide (HU/HC) prescription (Yes/No). The CKD risk categories used for stratification were based on both Estimated glomerular filtration rate(eGFR) and albuminuria assessed by Albumin/creatinine ratio (ACR).
Contacts and Locations
University of Alabama Birmingham
Birmingham, Alabama 35233
United States
University of Illinois Hospital and Health Sciences System .
Chicago, Illinois 60612
United States
Our Lady of the Lake Regional Medic .
Baton Rouge, Louisiana 70809
United States
East Carolina University BrodySchool of Med 3
Greenville, North Carolina 27858
United States
Univ of Tenn Health Sciences Ctr
Memphis, Tennessee 38163
United States
University of Texas Health Science Center at Houston
Houston, Texas 77030
United States
Novartis Investigative Site
Rio de Janeiro-Rio de Janeiro
20.211-030
Brazil
Novartis Investigative Site
São Paulo-São Paulo
01232-010
Brazil
Novartis Investigative Site
Porto Alegre
90035-003
Brazil
Novartis Investigative Site
94010 Créteil
France
Novartis Investigative Site
75015 Paris
France
Novartis Investigative Site
115 27 Athens
Greece
Novartis Investigative Site
41221 Larissa
Greece
Novartis Investigative Site
Dublin
DO8
Ireland
Novartis Investigative Site
Tripoli 1434
Lebanon
Novartis Investigative Site
1105 AZ Amsterdam
Netherlands
Novartis Investigative Site
Panama City
Panama
Novartis Investigative Site
08035 Barcelona Catalonia
Spain
Novartis Investigative Site
London
SE1 9RT
United Kingdom
Novartis Investigative Site
London
SE5 9RS
United Kingdom
Novartis Investigative Site
London
W12 0HS
United Kingdom