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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 26, 2021
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 (SCD) 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 : February 27, 2023

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) and/or ACE (angiotensin-converting enzyme) inhibitors and/or 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) and/or ACE (angiotensin-converting enzyme) inhibitors and/or 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 ]
    Proportion of patients with ≥ 30% decrease in ACR at 12 months compared to baseline.


Secondary Outcome Measures :
  1. Mean change from baseline in albuminuria (ACR) [ Time Frame: Baseline to 3, 6, 9, and 12 months ]
    Mean change in ACR from baseline to 3, 6, 9, and 12 months of treatment.

  2. Percentage of patients with ≥ 30% decrease in albuminuria (ACR) [ Time Frame: Baseline to 6 months ]
    Proportion of patients with ≥ 30% decrease in ACR at 6 months compared to baseline

  3. Percentage of patients with ≥ 20% improvement of protein to creatinine ratio (PCR) [ Time Frame: Baseline to 12 months ]
    Proportion of patients with PCR improvement at 12 months compared to baseline. Improvement: ≥ 20% decrease in PCR from baseline

  4. Percentage of patients with a stable (within ± 20% change) protein to creatinine ratio (PCR) [ Time Frame: Baseline to 12 months ]
    Proportion of patients with stable PCR at 12 months compared to baseline. Stable: within ± 20% change in PCR from baseline

  5. Percentage change in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to 3, 6, 9, and 12 months ]
    Percentage change in eGFR from baseline to 3, 6, 9, and 12 months of treatment

  6. Slope of albumin to creatinine ratio (ACR) decline [ Time Frame: Baseline to 3, 6, 9, and 12 months ]
    Slope of ACR decline from baseline to 12 months of treatment based on ACR values at baseline and at 3, 6, 9, and 12 months

  7. Slope of estimated glomerular filtration rate (eGFR) decline [ Time Frame: Baseline to 3, 6, 9, and 12 months ]
    Slope of eGFR decline from baseline to 12 months of treatment based on eGFR values at baseline and at 3, 6, 9, and 12 months

  8. Percentage of patients with progression of chronic kidney disease (CKD) [ Time Frame: Baseline to 12 months ]
    Proportion of patients with progression of CKD from baseline to 12 months

  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 ]
    Measurement of ADA to crizanlizumab at select time points

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

  11. Trough serum concentration (Ctrough) of crizanlizumab [ Time Frame: Baseline to follow-up period, at select time points approx. 1 year and 4 months ]
    Crizanlizumab pre-dose/trough pharmacokinetic samples will be taken at select time points


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 ≤ 130 (women), ≥ 45 to ≤ 140 (men) mL/min/1.73 m2 based on CKD-EPI formula
  • Patients with ACR of ≥ 100 to < 2000 mg/g
  • Receiving at least 1 standard of care drug(s) for SCD-related CKD: HU/HC for at least 6 months and on a stable dose for 3 months, and/or an ACE inhibitor and/or ARB for 3 months and on a stable dose for those 3 months.
  • Hb ≥ 4.0 g/dL, absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L, and platelet count ≥ 75 x 10^9/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 > 130/80 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
  • Body mass index of ≥ 35
  • Currently receiving or received voxelotor within 6 months of screening

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, Alabama
University of Alabama Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Ronson Washington    843-792-1815    ronsonwashington@uabmc.edu   
Principal Investigator: Julie Kanter-Washko         
United States, Illinois
University of Illinois Hospital and Health Sciences System Recruiting
Chicago, Illinois, United States, 60612
Contact: Hassan Taif       tohassan@uic.edu   
Principal Investigator: Santosh Saraf         
United States, Louisiana
Our Lady of the Lake Regional Medical Center Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Julie Doyle    225-214-3638    Julie.Doyle@fmolhs.org   
Principal Investigator: Vince Cataldo         
LSU Medical Center Recruiting
Shreveport, Louisiana, United States, 71130
Contact: Harriet Johnson    318-675-5661    hjohn3@lsuhsc.edu   
Principal Investigator: Richard Mansour         
United States, Tennessee
Univ of Tenn Health Sciences Ctr Recruiting
Memphis, Tennessee, United States, 38163
Contact: Paula S McCune    901-448-2813    pmccune@uthsc.edu   
Principal Investigator: Kenneth Ataga         
United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Arlene White-Brisco    713-500-6852    Arlene.whitebrisco@uth.tmc   
Principal Investigator: Modupe Idowu         
Brazil
Novartis Investigative Site Recruiting
Rio de Janeiro, RJ, Brazil, 20.211-030
Novartis Investigative Site Recruiting
Sao Paulo, SP, Brazil, 05403 000
Novartis Investigative Site Recruiting
Sao Paulo, SP, Brazil, 08270-070
Novartis Investigative Site Recruiting
São Paulo, SP, Brazil, 01232-010
Novartis Investigative Site Recruiting
Porto Alegre, Brazil, 90035-003
France
Novartis Investigative Site Recruiting
Creteil, France, 94000
Novartis Investigative Site Recruiting
Paris, France, 75015
Greece
Novartis Investigative Site Recruiting
Athens, Greece, 115 27
Novartis Investigative Site Recruiting
Patras, Greece, 265 00
Italy
Novartis Investigative Site Recruiting
Genova, GE, Italy, 16128
Novartis Investigative Site Recruiting
Gela, Sicily, Italy, 93012
Novartis Investigative Site Recruiting
Verona, VR, Italy, 37126
Netherlands
Novartis Investigative Site Recruiting
Amsterdam, Netherlands, 1105 AZ
South Africa
Novartis Investigative Site Recruiting
Soweto, Gauteng, South Africa, 2013
Spain
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Madrid, Spain, 28009
Novartis Investigative Site Recruiting
Madrid, Spain, 28034
Turkey
Novartis Investigative Site Recruiting
Adana, Turkey, 01250
Novartis Investigative Site Recruiting
Adana, Turkey, 01330
Novartis Investigative Site Recruiting
Antakya / Hatay, Turkey, 31100
United Kingdom
Novartis Investigative Site Recruiting
London, United Kingdom, SE5 9RS
Novartis Investigative Site Recruiting
London, United Kingdom, W12 0HS
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 26, 2021
Last Verified: February 2021
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