October, 10 2019

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

Age

> 16 Years

Genotypes

SS, Sβ0-thal

Phase

Phase 2

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 Type

Interventional

Phase

Phase 2

Age

> 16 Years

Genotype

SS, Sβ0-thal

Gender

All

Inclusion Criteria

– Confirmed diagnosis of SCD (HbSS and HbSβ0-thal SCD genotypes are eligible)

– Patients with eGFR ≥ 45 to ≤ 120 mL/min/1.73 m2 based on CKD EPI formula

– Patients with ACR of ≥ 100 to < 2000 mg/g - Receiving standard of care drug(s) for SCD and/or CKD for at least 6 months prior to study entry - Hb ≥ 4.0 g/dL, absolute neutrophil count (ANC) ≥ 1.0 x 109/L, and platelet count ≥ 75 x 109/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 > 140/90 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

Other protocol-defined inclusion/exclusion criteria may apply

Interventions

  • Drug

Outcome measures

  • Percentage of patients with ≥ 30% decrease in albuminuria (ACR)

Contact Research Team

  • Novartis Pharmaceuticals
    +41613241111
  • Novartis Pharmaceuticals
    1-888-669-6682

More info

View on ClinicalTrials
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