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 |
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Recruitment Status :
Recruiting
First Posted : August 12, 2019
Last Update Posted : October 19, 2020
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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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 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 Genetics related topics:
Sickle cell disease
MedlinePlus related topics:
Kidney Diseases
| Arm | Intervention/treatment |
|---|---|
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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.
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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) |
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Active Comparator: standard of care
Patients in the standard of care alone arm will continue to receive their usual standard of care treatment.
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Drug: Standard of Care
HU/HC (hydroxyurea/hydroxycarbamide) and/or ACE (angiotensin-converting enzyme) inhibitors and/or ARBs (angiotensin-receptor blocker) |
Primary Outcome Measures :
- 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 :
- 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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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
Information from the National Library of Medicine
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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
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
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novartis.email@novartis.com | |
| Contact: Novartis Pharmaceuticals | +41613241111 | novartis.email@novartis.com |
Locations
| 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: Emily Perdue 225-214-3638 Emily.Perdue@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 |
| Patras, Greece, 265 00 | |
| Italy | |
| 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
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| 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: | October 19, 2020 |
| Last Verified: | October 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. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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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 |