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Monoclonal Antibodies

Crizanlizuamb for Sickle Cell Disease (STEADFAST Trial)

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3, 6, 9, and 12 months

Awards & highlights

STEADFAST Trial 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

STEADFAST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3, 6, 9, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3, 6, 9, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3, 6, 9, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Albuminuria

Secondary outcome measures

Annualized rate of visits to emergency room (ER) and hospitalizations

Change from baseline in albuminuria (ACR) at 3, 6, 9 and 12 months

Immunogenicity: Levels of anti-drug antibodies (ADA) to crizanlizumab.

+8 more

STEADFAST Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: crizanlizumab + standard of careExperimental Treatment2 Interventions

5 mg/kg by intravenous (i.v.) infusion at Week 1 Day 1, Week 3 Day 1 and Day 1 of every 4-week cycle until Week 51 in addition to their usual standard of care treatment.

Group II: standard of careActive Control1 Intervention

Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Crizanlizuamb

2019

Completed Phase 2

~60

Standard of Care

2017

Completed Phase 4

~4420

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,296 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this research been conducted before?

"Currently, there are 10 ongoing studies for Crizanlizuamb in 144 cities across 36 countries. The first trial began in 2017 and was completed in the Phase 2 drug approval stage. This study had 57 participants and was sponsored by Novartis Pharmaceuticals. Since then, 229 more trials have been completed."

Answered by AI

Is Crizanlizuamb a safe medication for human patients?

"Crizanlizuamb's safety is based on phase 2 trial data, which suggests that while there are no guarantees of efficacy, the medication is safe to use."

Answered by AI

How many individuals are enrolled in this experiment?

"This particular trial is no longer looking for new patients as of October 24th, 2022. The study was first posted on December 10th, 2019. If you are interested in other clinical trials, there are 714 active studies involving kidney diseases and 10 involving Crizanlizuamb."

Answered by AI

Are new participants able to join this clinical trial at this time?

"Recruitment for this study has concluded. The trial was first posted on December 10th, 2019 and ended on October 24th, 2022. However, there are 714 other trials involving patients with kidney diseases and 10 trials for Crizanlizuamb that are actively looking for participants."

Answered by AI

Are there other examples in the medical literature of Crizanlizuamb being studied?

"The first study of crizanlizuamb was completed in 2017 by researchers at East Carolina University. Since the publication of that initial study, there have been 229 more studies published on the topic. Currently, there are 10 active clinical trials related to crizanlizuamb taking place across the United States of America; many of these studies are based out of Philadelphia."

Answered by AI

Is this trial widely available in North America?

"Currently, there are 11 sites conducting this study. They are situated in places like Philadelphia, Memphis and Houston. To reduce the amount of travelling required, patients are encouraged to choose the location nearest to them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease

2019. "Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04053764.