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: Feb 26, 2021

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

170 participants

Start date

Dec 10, 2019

Completion date

Feb 27, 2023

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 ≤ 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

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