Crizanlizuamb for Sickle Cell Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Sickle Cell DiseaseCrizanlizuamb - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare how well crizanlizumab + standard of care works to standard of care alone in treating kidney disease in sickle cell patients.

Eligible Conditions
  • Sickle Cell Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 17 Secondary · Reporting Duration: Baseline to 3, 6, 9, and 12 months

Baseline to 12 months
Percentage of patients with a stable (within ± 20% change) protein to creatinine ratio (PCR)
Inverse PCR
Percentage of patients with progression of chronic kidney disease (CKD)
Percentage of patients with progression of chronic kidney disease (CKD) at 12 months
Inverse PCR
Percentage of patients with ≥ 20% improvement of protein to creatinine ratio (PCR)
Albuminuria
Month 12
Change from baseline in albuminuria (ACR) at 3, 6, 9 and 12 months
Mean change from baseline in albuminuria (ACR)
Percentage change in estimated glomerular filtration rate (eGFR)
Slope of albumin to creatinine ratio (ACR) decline
Slope of estimated glomerular filtration rate (eGFR) decline
Baseline to 6 months
Percentage of patients with ≥ 30% decrease in albuminuria (ACR)
Percentage of patients with ≥ 30% decrease in albuminuria (ACR) at 6 months
Year 1
Annualized rate of visits to emergency room (ER) and hospitalizations
Immunogenicity: Levels of anti-drug antibodies (ADA) to crizanlizumab.
Trough serum concentration (Ctrough) of crizanlizumab
Year 1
Immunogenicity: measurement of anti-drug antibodies (ADA) to crizanlizumab.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

standard of care
1 of 2
crizanlizumab + standard of care
1 of 2

Active Control

Experimental Treatment

58 Total Participants · 2 Treatment Groups

Primary Treatment: Crizanlizuamb · No Placebo Group · Phase 2

crizanlizumab + standard of careExperimental Group · 2 Interventions: Standard of Care, Crizanlizuamb · Intervention Types: Drug, Drug
standard of care
Drug
ActiveComparator Group · 1 Intervention: Standard of Care · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care
2017
Completed Phase 4
~10020

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 3, 6, 9, and 12 months

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,717 Previous Clinical Trials
3,524,846 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are receiving at least 1 standard of care drug(s) for SCD-related CKD.
You have an ALT level of less than 3.0 times the ULN.
Direct bilirubin is less than 3.0 times the upper limit of normal (ULN).