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

About the study

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.

Study point of contact

Novartis Pharmaceuticals
+41613241111
novartis.email@novartis.com
Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Locations

9 United States sites

5 Brazil sites

4 Spain sites

3 Italy sites

3 Turkey sites

3 United Kingdom sites

2 France sites

2 Greece sites

2 South Africa sites

1 Netherlands site

1 Lebanon site

1 Panama site

Age

> 16 Years

Genotypes

HbSS

Phase

Phase 2

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

participation requirements

– 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

participation restrictions

– 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

Locations

  • Birmingham, Alabama, United States, University of Alabama Birmingham, 35233 [Recruiting]
  • Gainesville, Florida, United States, University of Florida, 32611 [Recruiting]
  • Atlanta, Georgia, United States, Emory University School of Medicine, 30322 [Recruiting]
  • Chicago, Illinois, United States, University of Illinois Hospital and Health Sciences System, 60612 [Recruiting]
  • Baton Rouge, Louisiana, United States, Our Lady of the Lake Regional Medical Center, 70809 [Recruiting]
  • Shreveport, Louisiana, United States, LSU Medical Center, 71130 [Recruiting]
  • Greenville, North Carolina, United States, East Carolina University BrodySchool of Med. (3), 27858 [Recruiting]
  • Memphis, Tennessee, United States, Univ of Tenn Health Sciences Ctr, 38163 [Recruiting]
  • Houston, Texas, United States, University of Texas Health Science Center at Houston, 77030 [Recruiting]
  • Rio de Janeiro, RJ, Brazil, Novartis Investigative Site, 20.211-030 [Recruiting]
  • Sao Paulo, SP, Brazil, Novartis Investigative Site, 05403 000 [Recruiting]
  • Sao Paulo, SP, Brazil, Novartis Investigative Site, 08270-070 [Recruiting]
  • São Paulo, SP, Brazil, Novartis Investigative Site, 01232-010 [Recruiting]
  • Porto Alegre, Brazil, Novartis Investigative Site, 90035-003 [Recruiting]
  • Creteil, France, Novartis Investigative Site, 94000 [Recruiting]
  • Paris, France, Novartis Investigative Site, 75015 [Recruiting]
  • Athens, Greece, Novartis Investigative Site, 115 27 [Recruiting]
  • Patras, Greece, Novartis Investigative Site, 265 00 [Recruiting]
  • Genova, GE, Italy, Novartis Investigative Site, 16128 [Recruiting]
  • Gela, Sicily, Italy, Novartis Investigative Site, 93012 [Recruiting]
  • Verona, VR, Italy, Novartis Investigative Site, 37126 [Recruiting]
  • Tripoli, Lebanon, Novartis Investigative Site, 1434 [Recruiting]
  • Amsterdam, Netherlands, Novartis Investigative Site, 1105 AZ [Recruiting]
  • Panama City, Panama, Novartis Investigative Site, 0801 [Recruiting]
  • Soweto, Gauteng, South Africa, Novartis Investigative Site, 2013 [Recruiting]
  • Johannesburg, Guateng, South Africa, Novartis Investigative Site, 2193 [Recruiting]
  • Sevilla, Andalucia, Spain, Novartis Investigative Site, 41013 [Recruiting]
  • Barcelona, Catalunya, Spain, Novartis Investigative Site, 08035 [Recruiting]
  • Madrid, Spain, Novartis Investigative Site, 28009 [Recruiting]
  • Madrid, Spain, Novartis Investigative Site, 28034 [Recruiting]
  • Adana, Turkey, Novartis Investigative Site, 01250 [Recruiting]
  • Adana, Turkey, Novartis Investigative Site, 01330 [Recruiting]
  • Antakya / Hatay, Turkey, Novartis Investigative Site, 31100 [Recruiting]
  • London, United Kingdom, Novartis Investigative Site, SE1 9RT [Recruiting]
  • London, United Kingdom, Novartis Investigative Site, SE5 9RS [Recruiting]
  • London, United Kingdom, Novartis Investigative Site, W12 0HS [Recruiting]
Last updated 2021-09-10