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Trial details
SEG101A2203 Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease
Current status:
Approved
|
Date registered:
25/07/2023
Trial version(s)
History: 13/09/2020
History: 13/09/2020
History: 13/09/2020
History: 13/09/2020
History: 13/09/2020
History: 13/09/2020
History: 13/09/2020
History: 13/09/2020
History: 13/09/2020
History: 13/09/2020
History: 13/09/2020
History: 13/09/2020
Current: 13/09/2020
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Main Information
Primary registry identifying number
LBCTR2020094586
Protocol number
SEG101A2203
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Novartis Pharmaceuticals
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
SEG101A2203 Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease
Acronym
SEG101A2203 STEADFAST
Scientific 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
Acronym
Brief summary of the study: English
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.
Brief summary of the study: Arabic
دراسة مرحلة ثانية، متعددة المراكز، عشوائيّة التوزيع، مفتوحة اللصاقة، من مجموعتين لمقارنة تأثير كريزانليزوماب + الرعاية المعتمدة بالرعاية المعتمدة لوحدها، على الوظيفة الكلويّة لدى مرضى داء الكريات المنجليّة ≥ 16 سنة المصابين بمرض كلويّ مزمن ناتج عن اعتلال الكلية المنجلي (STEADFAST)
Health conditions/problem studied: Specify
Sickle Cell Disease (SCD)
Interventions: Specify
Drug: Crizanlizumab (SEG101)
Key inclusion and exclusion 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
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
16
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: 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
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
N/A
Study phase
2
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
Yes, Worldwide
IMP has market authorization: Specify the countries
US, albania, bahrain, brazil, india , UAE
Name of IMP
Crizanlizumab
Type of IMP
Immunological
Pharmaceutical class
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
Therapeutic indication
Patients with: Sickle cell diseas
Therapeutic benefit
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
Biospecimen retention
Samples without DNA
Biospecimen description
Samples will be sent to Covance central lab
Target sample size
5
Actual enrollment target size
1
Date of first enrollment: Type
Actual
Date of first enrollment: Date
01/12/2021
Date of study closure: Type
Actual
Date of study closure: Date
29/03/2023
Recruitment status
Complete
Date of completion
15/12/2021
IPD sharing statement plan
Yes
IPD sharing statement 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.
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT04053764?term=CSEG101A2203&draw=2&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
clinical trials.gov
NCT04053764
Sources of Monetary or Material Support
Name
Novartis Pharmaceuticals
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Adlette
Inati
Tripoli
Lebanon
9613228033
adlette.inati@lau.edu.lb
Nini Hospital
Scientific
Hind
Khairallah
Beirut
Lebanon
9611512002
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Nini Hospital
Adlette Inati
Hematology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Nini Hospital
17/08/2020
Nabil Kabbara
Nabil.kabbara@hopitalnini.com
961 (0) 6 431 400 ext 1062
Countries of Recruitment
Name
Lebanon
Brazil
France
Greece
Netherlands
Spain
Turkey
Health Conditions or Problems Studied
Condition
Code
Keyword
Sickle cell
Sickle-cell disorders (D57)
SCD
Interventions
Intervention
Description
Keyword
ICF-Labs-IMP administration-Questionnaires
ICF-Labs-IMP administration-Questionnaires
ICF-Labs-IMP administration-Questionnaires
Primary Outcomes
Name
Time points
Measure
To evaluate the effect of crizanlizumab + standard of care compared to standard of care alone on albuminuria (ACR) decrease
12 months
12 Months
Key Secondary Outcomes
Name
Time points
Measure
Mean change in albuminuria (ACR)
3,6,9,12 months
3,6,9,12 months
Percentage of patients with ≥ 30% decrease in albuminuria (ACR)
Baseline to 6 months
Baseline to 6 months
Percentage of patients with ≥ 20% improvement of protein to creatinine ratio (PCR)
Baseline to 12 months
Baseline to 12 months
Percentage of patients with a stable (within ± 20% change) protein to creatinine ratio (PCR)
Baseline to 12 months
Baseline to 12 months
Percentage change in estimated glomerular filtration rate (eGFR)
Baseline to 3, 6, 9 and 12 months
Baseline to 3, 6, 9 and 12 months
Slope of albumin to creatinine ratio (ACR) decline
Baseline, 3, 6, 9, and 12 months
Baseline, 3, 6, 9, and 12 months
Slope of estimated glomerular filtration rate (eGFR) decline
Baseline to 3, 6, 9 and 12 months
Baseline to 3, 6, 9 and 12 months
Percentage of patients with progression of chronic kidney disease (CKD)
Baseline to 12 months
Baseline to 12 months
Immunogenicity: measurement of anti-drug antibodies (ADA) to crizanlizumab
Baseline to follow-up period
Baseline to follow-up period
Annualized rate of visits to emergency room and hospitalizations
Baseline to follow-up period
Baseline to follow-up period
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Investigator Letter-EMA CHMP Recommendation
30/05/2023
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