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

Last Update: May 03, 2021

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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.

Condition 
Sickle Cell Disease (SCD)
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
148 participants
Start date 
Dec 10, 2019
Completion date 
Apr 04, 2024
Gender 
All
Age(s)
16 Years and older (Child, Adult, Older Adult)

Interventions

Drug
Crizanlizuamb
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
Drug
Standard of Care
HU/HC (hydroxyurea/hydroxycarbamide) and/or ACE (angiotensin-converting enzyme) inhibitors and/or ARBs (angiotensin-receptor blocker)

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of SCD (HbSS and HbSβ0-thal SCD genotypes are eligible)
Patients with 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)
Patients with ACR of ≥ 100 to < 2000 mg/g (taken as an average of the three screening ACR values to determine eligibility)
Receiving at least 1 standard of care drug(s) for SCD-related CKD: If receiving HU/HC, the patient must have been receiving 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

Adequate hepatic function as defined by:

Alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN)
Direct (conjugated) bilirubin ≤ 3.0 x ULN
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 (can decrease interval to within 6 weeks of study entry only if renal function has returned to pre-AKI values prior to study entry)
Blood pressure > 140/90 mmHg despite treatment
Patients undergoing renal replacement therapy (ie. hemodialysis, peritoneal dialysis, hemofiltration and kidney transplantation)
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
Patient has received crizanlizumab and/or other selectin inhibitor or plans to receive it during the duration of the study.

Other protocol-defined inclusion/exclusion criteria may apply

Study Locations

United States
University of Alabama Birmingham
Recruiting
Birmingham, 35233
Alabama
United States
University of Illinois Hospital and Health Sciences System
Recruiting
Chicago, 60612
Illinois
United States
Our Lady of the Lake Regional Medical Center
Recruiting
Baton Rouge, 70809
Louisiana
United States
LSU Medical Center
Recruiting
Shreveport, 71130
Louisiana
United States
Univ of Tenn Health Sciences Ctr
Recruiting
Memphis, 38163
Tennessee
United States
University of Texas Health Science Center at Houston
Recruiting
Houston, 77030
Texas
United States
Brazil
Novartis Investigative Site
Recruiting
Rio de Janeiro, 20.211-030
RJ
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 05403 000
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 08270-070
SP
Brazil
Novartis Investigative Site
Recruiting
São Paulo, 01232-010
SP
Brazil
Novartis Investigative Site
Recruiting
Porto Alegre, 90035-003
-
Brazil
France
Novartis Investigative Site
Recruiting
Creteil, 94000
-
France
Novartis Investigative Site
Recruiting
Paris, 75015
-
France
Greece
Novartis Investigative Site
Recruiting
Athens, 115 27
-
Greece
Novartis Investigative Site
Recruiting
Patras, 265 00
-
Greece
Italy
Novartis Investigative Site
Recruiting
Genova, 16128
GE
Italy
Novartis Investigative Site
Recruiting
Gela, 93012
Sicily
Italy
Novartis Investigative Site
Recruiting
Verona, 37126
VR
Italy
Netherlands
Novartis Investigative Site
Recruiting
Amsterdam, 1105 AZ
-
Netherlands
Panama
Novartis Investigative Site
Recruiting
Panama City, 0801
-
Panama
South Africa
Novartis Investigative Site
Recruiting
Soweto, 2013
Gauteng
South Africa
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41013
Andalucia
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Novartis Investigative Site
Recruiting
Madrid, 28034
-
Spain
Turkey
Novartis Investigative Site
Recruiting
Adana, 01250
-
Turkey
Novartis Investigative Site
Recruiting
Adana, 01330
-
Turkey
Novartis Investigative Site
Recruiting
Antakya / Hatay, 31100
-
Turkey
United Kingdom
Novartis Investigative Site
Recruiting
London, SE1 9RT
-
United Kingdom
Novartis Investigative Site
Recruiting
London, SE5 9RS
-
United Kingdom
Novartis Investigative Site
Recruiting
London, W12 0HS
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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