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

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ClinicalTrials.gov Identifier: NCT04053764
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Crizanlizuamb Drug: Standard of Care Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 10, 2019
Estimated Primary Completion Date : June 6, 2022
Estimated Study Completion Date : September 17, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: crizanlizumab + standard of care
5 mg/kg by intravenous 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.
 Drug: Crizanlizuamb
Crizanlizumab is a concentrate for solution for infusion, i.v. use. Supplied in single use 10 mL vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab
Other Name: SEG101

Drug: Standard of Care
HU/HC (hydroxyurea/hydroxycarbamide), ACE (angiotensin-converting enzyme)inhibitors, and ARBs (angiotensin-receptor blocker)
Active Comparator: standard of care
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
 Drug: Standard of Care
HU/HC (hydroxyurea/hydroxycarbamide), ACE (angiotensin-converting enzyme)inhibitors, and ARBs (angiotensin-receptor blocker)


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients with ≥ 30% decrease in albuminuria (ACR) [ Time Frame: Baseline to 12 months ]
    To evaluate the effect of crizanlizumab + standard of care compared to standard of care alone on albuminuria (ACR) decrease


Secondary Outcome Measures :
  1. Mean change in albuminuria (ACR) [ Time Frame: baseline to 3, 6, 9, and 12 months ]
    To evaluate the effect of crizanlizumab + standard of care compared to standard of care alone on change in albuminuria (ACR)

  2. Percentage of patients with ≥ 30% decrease in albuminuria (ACR) [ Time Frame: Baseline to 6 months ]
    To evaluate the effect of crizanlizumab + standard of care compared to standard of care alone on albuminuria (ACR) decrease

  3. Percentage of patients with ≥ 20% improvement of protein to creatinine ratio (PCR) [ Time Frame: Baseline to 12 months ]
    To evaluate the effect of crizanlizumab + standard of care compared to standard of care alone on protein to creatinine ratio (PCR)

  4. Percentage of patients with a stable (within ± 20% change) protein to creatinine ratio (PCR) [ Time Frame: Baseline to 12 months ]
    To evaluate the effect of crizanlizumab + standard of care compared to standard of care alone on protein to creatinine ratio (PCR)

  5. Percentage change in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to 3, 6, 9 and 12 months ]
    To evaluate the effect of crizanlizumab + standard of care compared to standard of care alone on the percentage change in estimated glomerular filtration rate (eGFR)

  6. Slope of albumin to creatinine ratio (ACR) decline [ Time Frame: Baseline, 3, 6, 9, and 12 months ]
    To evaluate the effect of crizanlizumab + standard of care compared to standard of care alone on albumin to creatinine ratio (ACR) decline rate

  7. Slope of estimated glomerular filtration rate (eGFR) decline [ Time Frame: Baseline to 3, 6, 9 and 12 months ]
    To evaluate the effect of crizanlizumab + standard of care compared to standard of care alone on estimated glomerular filtration rate (eGFR) decline rate

  8. Percentage of patients with progression of chronic kidney disease (CKD) [ Time Frame: Baseline to 12 months ]
    To evaluate the effect of crizanlizumab + standard of care compared to standard of care alone on the progression of chronic kidney disease (CKD)

  9. Immunogenicity: measurement of anti-drug antibodies (ADA) to crizanlizumab [ Time Frame: Baseline to follow-up period, at select time points approx. 1 year and 4 months ]
    To assess the immunogenicity of crizanlizumab over the study period

  10. Annualized rate of visits to emergency room and hospitalizations [ Time Frame: Baseline to follow-up period, approx. 1 year and 4 months ]
    To evaluate healthcare resource utilization (visits to emergency room and hospitalizations) due to Acute Kidney Injury (AKI) events, Vaso-occlusive crisis (VOCs), or other Sickle Cell Disease (SCD) complications.


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053764


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

Locations
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United States, Louisiana
Our Lady of the Lake Regional Medical Center Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact    225-214-3638      
Principal Investigator: Vince Cataldo         
Spain
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Madrid, Spain, 28009
Novartis Investigative Site Recruiting
Madrid, Spain, 28034
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04053764    
Other Study ID Numbers: CSEG101A2203
2018-003608-38 ( EudraCT Number )
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
SEG101
SCD
Crizanlizumab
Sickle cell nephropathy
chronic kidney disease
 CKD
albuminuria (ACR)
renal function
standard of care
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia, Sickle Cell
Urologic Diseases
Renal Insufficiency
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn