Sickle Cell Disease (STEADFAST)

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Sickle Cell Disease (STEADFAST)

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.

Overview

This study is recruiting: Phase II Actual Start Date: [December 10, 2019] Estimated Completion Date: [September 17, 2022] Novartis Reference Number: CSEG101A2203
Condition: Sickle Cell Disease Interventions: Crizanlizumab, Standard of Care Estimated Enrollment: [170 participants] ClinicalTrials.gov Identifier: NCT04053764
This study is recruiting: Phase II Actual Start Date: [December 10, 2019]
Estimated Completion Date: [September 17, 2022] Novartis Reference Number: CSEG101A2203
Condition: Sickle Cell Disease Interventions: Crizanlizumab, Standard of Care
Estimated Enrollment: [170 participants] ClinicalTrials.gov Identifier: NCT04053764

Study Goal

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 (SCD) patients ≥ 16 years with chronic kidney disease (CKD) due to sickle cell nephropathy.

All drugs 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.

Eligibility

Participants may be eligible to participate if they:

  • Confirmed diagnosis of SCD (HbSS and HbSβ0-thal SCD genotypes are eligible)
  • Have an eGFR ≥ 45 to ≤ 120 mL/min/1.73 m2 based on CKD-EPI formula
  • ACR of ≥ 100 to < 2000 mg/g
  • Are receiving standard of care drug(s) for SCD and/or CKD for at least 6 months prior to study entry
  • Hemoglobin ≥ 4.0 g/dL ANC ≥ 1.0 x 109/L, and platelet count ≥ 75 x 109/L
  • Meet other eligibility criteria
  • Other protocol-defined inclusion/exclusion criteria may apply

If you're interested in this clinical study, your doctor can help evaluate whether you are eligible to participate. Ask your doctor if your medical history or other treatments you're receiving may conflict with the study protocol. If you meet the eligibility criteria and agree to participate in the study: You will be required to sign an informed consent form (ICF). The ICF contains information about the study, which your doctor can help explain to you before you sign. Your doctor will need to complete the necessary tests to see if you are eligible. As with all clinical trials, you have the right to leave the study at any time, for any reason.

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To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.

For other sickle cell disease trials you might be interested in click here.

Definitions:
ANC - absolute neutrophil count, CKD - chronic kidney disease, CKD-EPI - chronic kidney disease epidemiology collaboration, eGFR - estimated glomerular filtration rate, ICF - informed consent form, SCD - sickle cell disease

Last Updated: Dec 10, 2019

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