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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05485961




Registration number
NCT05485961
Ethics application status
Date submitted
29/07/2022
Date registered
3/08/2022

Titles & IDs
Public title
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
Scientific title
A Phase 2b/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis
Secondary ID [1] 0 0
2022-500273-14-00
Secondary ID [2] 0 0
CSL300_2301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease 0 0
End Stage Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CSL300
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo

Experimental: CSL300 (low dose)(Phase 2b) - Intravenous (IV) administration

Experimental: CSL300 (medium dose)(Phase 2b) - IV administration

Experimental: CSL300 (high dose)(Phase 2b) - IV administration

Placebo comparator: Placebo (Phase 2b) - IV administration

Experimental: CSL300 (Phase 3) - IV administration

Placebo comparator: Placebo (Phase 3) - IV administration


Treatment: Drugs: CSL300
Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6

Treatment: Drugs: Placebo
0.9% w/v NaCl

Treatment: Drugs: Placebo
Part 2 (Phase 3): Matching the excipient content and concentration of the CSL300 product, minus the active ingredient
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)
Timepoint [1] 0 0
Up to 12 weeks
Primary outcome [2] 0 0
Time to first occurrence of CV death or MI (Phase 3)
Timepoint [2] 0 0
Approximately 5 years
Secondary outcome [1] 0 0
Percent of subjects achieving hs-CRP < 2.0 mg/L (Phase 2b)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Change from baseline in log-transformed hs-CRP (Phase 2b)
Timepoint [2] 0 0
Up to 24 weeks
Secondary outcome [3] 0 0
Mean change from Baseline in SAA (Phase 2b)
Timepoint [3] 0 0
Up to 12 weeks
Secondary outcome [4] 0 0
Mean change from Baseline in sPLA2 (Phase 2b)
Timepoint [4] 0 0
Up to 12 weeks
Secondary outcome [5] 0 0
Mean change from Baseline in fibrinogen (Phase 2b)
Timepoint [5] 0 0
Up to 12 weeks
Secondary outcome [6] 0 0
Mean change from Baseline in PAI-1 (Phase 2b)
Timepoint [6] 0 0
Up to 12 weeks
Secondary outcome [7] 0 0
Mean change from Baseline in Lp (a) (Phase 2b)
Timepoint [7] 0 0
Up to 12 weeks
Secondary outcome [8] 0 0
Mean change from Baseline in Hepcidin (Phase 2b)
Timepoint [8] 0 0
Up to 12 weeks
Secondary outcome [9] 0 0
Mean change from Baseline in hemoglobin (Phase 2b)
Timepoint [9] 0 0
Up to 12 weeks
Secondary outcome [10] 0 0
Mean change from Baseline in ESA (Phase 2b)
Timepoint [10] 0 0
Up to 12 weeks
Secondary outcome [11] 0 0
Mean change from Baseline in ERI (Phase 2b)
Timepoint [11] 0 0
Up to 12 weeks
Secondary outcome [12] 0 0
Mean change from Baseline in iron (Phase 2b)
Timepoint [12] 0 0
Up to 12 weeks
Secondary outcome [13] 0 0
Mean change from Baseline in TIBC (Phase 2b)
Timepoint [13] 0 0
Up to 12 weeks
Secondary outcome [14] 0 0
Mean change from Baseline in TSAT (Phase 2b)
Timepoint [14] 0 0
Up to 12 weeks
Secondary outcome [15] 0 0
Mean change from Baseline in ferritin (Phase 2b)
Timepoint [15] 0 0
Up to 12 weeks
Secondary outcome [16] 0 0
Area under the plasma concentration versus time curve (AUC) for CSL300 (Phase 2b)
Timepoint [16] 0 0
Up to 24 weeks
Secondary outcome [17] 0 0
Peak Plasma Concentration (Cmax) for CSL300 (Phase 2b)
Timepoint [17] 0 0
Up to 24 weeks
Secondary outcome [18] 0 0
Trough Plasma Concentration (Ctrough) for CSL300 (Phase 2b)
Timepoint [18] 0 0
Up to 24 weeks
Secondary outcome [19] 0 0
Time to Maximum Plasma Concentration (Tmax) for CSL300 (Phase 2b)
Timepoint [19] 0 0
Up to 24 weeks
Secondary outcome [20] 0 0
Percent of subjects with AE, SAE, including AESIs (Phase 2b)
Timepoint [20] 0 0
Up to 32 weeks
Secondary outcome [21] 0 0
Mean change from Baseline in WBC (Phase 2b)
Timepoint [21] 0 0
Up to 12 weeks
Secondary outcome [22] 0 0
Mean change from Baseline in neutrophils (Phase 2b)
Timepoint [22] 0 0
Up to 12 weeks
Secondary outcome [23] 0 0
Mean change from Baseline in platelets (Phase 2b)
Timepoint [23] 0 0
Up to 12 weeks
Secondary outcome [24] 0 0
Mean change from Baseline in AST (Phase 2b)
Timepoint [24] 0 0
Up to 12 weeks
Secondary outcome [25] 0 0
Mean change from Baseline in ALT (Phase 2b)
Timepoint [25] 0 0
Up to 12 weeks
Secondary outcome [26] 0 0
Mean change from Baseline in total bilirubin (Phase 2b)
Timepoint [26] 0 0
Up to 12 weeks
Secondary outcome [27] 0 0
Mean change from Baseline in lipid panel (Phase 2b)
Timepoint [27] 0 0
Up to 12 weeks
Secondary outcome [28] 0 0
Titer of confirmed antibodies specific to CSL300 (Phase 2b)
Timepoint [28] 0 0
Up to 12 weeks
Secondary outcome [29] 0 0
Time to first occurrence of all-cause death or MI (Phase 3)
Timepoint [29] 0 0
Approximately 5 years
Secondary outcome [30] 0 0
Time to first occurrence of CV death, MI, or ischemic stroke (Phase 3)
Timepoint [30] 0 0
Approximately 5 years
Secondary outcome [31] 0 0
Time to first occurrence of CV death (Phase 3)
Timepoint [31] 0 0
Approximately 5 years
Secondary outcome [32] 0 0
Time to first occurrence of CV death, MI or major adverse limb event (Phase 3)
Timepoint [32] 0 0
Approximately 5 years
Secondary outcome [33] 0 0
Time to first occurrence of all-cause death (Phase 3)
Timepoint [33] 0 0
Approximately 5 years
Secondary outcome [34] 0 0
Time to first occurrence of CV death, MI, or hospitalization for heart failure (Phase 3)
Timepoint [34] 0 0
Approximately 5 years
Secondary outcome [35] 0 0
Total number of CV hospitalizations (Phase 3)
Timepoint [35] 0 0
Approximately 5 years
Secondary outcome [36] 0 0
Total number of HF hospitalizations and urgent visits (Phase 3)
Timepoint [36] 0 0
Approximately 5 years
Secondary outcome [37] 0 0
Total number of hospitalizations (Phase 3)
Timepoint [37] 0 0
Approximately 5 years

Eligibility
Key inclusion criteria
* Male or female at least 18 years of age
* A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks
* Serum hs-CRP = 2.0 mg/L
* A diagnosis of diabetes mellitus OR ASCVD
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3)
* Concomitant use of systemic immunosuppressant drugs
* Abnormal LFTs
* Any life-threatening disease expected to result in death within 12 months
* A history of GI perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
2310
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
03600017 - Concord Repatriation General Hospital - Sydney
Recruitment hospital [2] 0 0
03600021 - Sunshine Coast University Private Hospital - Nambour
Recruitment hospital [3] 0 0
03600014 - Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
03600013 - Monash Medical Centre - Clayton
Recruitment hospital [5] 0 0
03600011 - Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2139 - Sydney
Recruitment postcode(s) [2] 0 0
4560 - Nambour
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New Hampshire
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
Belgium
State/province [22] 0 0
Aalst
Country [23] 0 0
Belgium
State/province [23] 0 0
Bonheiden
Country [24] 0 0
Belgium
State/province [24] 0 0
Gent
Country [25] 0 0
Belgium
State/province [25] 0 0
Leuven
Country [26] 0 0
Belgium
State/province [26] 0 0
Liège
Country [27] 0 0
Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Germany
State/province [28] 0 0
Kiel
Country [29] 0 0
Germany
State/province [29] 0 0
Villingen-Schwenningen

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
CSL Behring
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
CSL Behring LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Registration Coordinator
Address 0 0
Country 0 0
Phone 0 0
610-878-4000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at [email protected].

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
Available to whom?
Proposed research should seek to answer a previously unanswered important medical or scientific question.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05485961