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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04419467
Registration number
NCT04419467
Ethics application status
Date submitted
3/06/2020
Date registered
5/06/2020
Date last updated
6/12/2023
Titles & IDs
Public title
Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
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Scientific title
A Phase 2a, Double-blind, Randomized, Placebo-controlled, Proof of Concept Study of Vascular Endothelial Growth Factor (VEGF)-B Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
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Secondary ID [1]
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CSL346_2001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetic Kidney Disease (DKD)
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - CSL346
Treatment: Drugs - Placebo
Experimental: CSL346 (low dose) - Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
Experimental: CSL346 (high dose) - Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
Placebo Comparator: Placebo - Administered as a single IV loading dose followed by SC infusions
Other interventions: CSL346
VEGF-B antagonist monoclonal antibody
Treatment: Drugs: Placebo
Normal saline
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR)
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Assessment method [1]
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Data are presented as the geometric mean (GM) of percent change, which is calculated as the geometric mean of the Week 16 ACR to baseline, expressed as percent change from baseline.
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Timepoint [1]
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Baseline up to Week 16
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Secondary outcome [1]
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Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
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Assessment method [1]
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Timepoint [1]
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Up to 24 weeks
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Secondary outcome [2]
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Percentage of Subjects With TEAEs
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Assessment method [2]
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Timepoint [2]
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Up to 24 weeks
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Secondary outcome [3]
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Number of Subjects With Adverse Events of Special Interest (AESIs)
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Assessment method [3]
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Data are presented for treatment-emergent AESIs.
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Timepoint [3]
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Up to 24 weeks
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Secondary outcome [4]
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Percentage of Subjects With AESIs
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Assessment method [4]
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Data are presented for treatment-emergent AESIs.
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Timepoint [4]
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Up to 24 weeks
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Secondary outcome [5]
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Observed Value and Mean Change From Baseline in Serum Creatinine
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Assessment method [5]
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Timepoint [5]
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Baseline up to 24 weeks
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Secondary outcome [6]
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Observed Value and Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
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Assessment method [6]
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Timepoint [6]
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Baseline up to 24 weeks
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Secondary outcome [7]
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Observed Value and Mean Change From Baseline in Systolic Blood Pressure
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Assessment method [7]
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Timepoint [7]
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Baseline up to 24 weeks
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Secondary outcome [8]
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Observed Value and Mean Change From Baseline in Diastolic Blood Pressure
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Assessment method [8]
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Timepoint [8]
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Baseline up to 24 weeks
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Secondary outcome [9]
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Maximum Concentration (Cmax) After Intravenous (IV) Loading Dose of CSL346 in Serum Samples
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Assessment method [9]
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Timepoint [9]
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Up to 120 minutes after the IV loading dose for CSL346
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Secondary outcome [10]
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Time to Reach Cmax in Serum (Tmax) After IV Loading Dose of CSL346 in Serum Samples
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Assessment method [10]
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Timepoint [10]
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Up to 120 minutes after the IV loading dose for CSL346
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Secondary outcome [11]
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Cmax After First Subcutaneous (SC) Dose of CSL346 in Serum Samples
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Assessment method [11]
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Timepoint [11]
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From Day 1 to Day 29
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Secondary outcome [12]
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Tmax After First SC Dose of CSL346 in Serum Samples
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Assessment method [12]
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Timepoint [12]
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From Day 1 to Day 29
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Secondary outcome [13]
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Area Under the Concentration-time Curve in First Dosing Interval
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Assessment method [13]
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Timepoint [13]
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From Day 1 to Day 29
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Secondary outcome [14]
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Trough Concentration After Each Dose
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Assessment method [14]
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Timepoint [14]
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29 days after each dose
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Secondary outcome [15]
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Number of Subjects Positive for Anti-drug Antibodies
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Assessment method [15]
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Data are presented for participants who received treatment with CSL346. Any anti-drug antibodies detected in participants who received treatment with Placebo were considered not specific to CSL346 and of no clinical relevance.
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Timepoint [15]
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Weeks 4, 8, and 16
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Secondary outcome [16]
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Percentage of Subjects Positive for Anti-drug Antibodies
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Assessment method [16]
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Data are presented for participants who received treatment with CSL346. Any anti-drug antibodies detected in participants who received treatment with Placebo were considered not specific to CSL346 and of no clinical relevance.
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Timepoint [16]
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Weeks 4, 8, and 16
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Eligibility
Key inclusion criteria
- Male and female subjects = 25 years of age with a diagnosis of type 2 diabetes
mellitus (T2DM)
- Urinary ACR = 150 mg/g
- eGFR > 20 mL/min/1.73m2
- Glycosylated HbA1c < 12%
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Minimum age
25
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Current diagnosis of type 1 diabetes mellitus
- History of acute kidney injury or chronic dialysis/renal transplant
- Uncontrolled hypertension or class III / IV heart failure
- Left ventricular ejection fraction < 50% by echocardiogram
- Troponin-I > the upper reference limit
- b-type natriuretic peptide > 200 pg/mL
- ALT > 2x the upper limit of normal
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/09/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/10/2022
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Sample size
Target
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Accrual to date
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Final
114
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Hunter Diabetes Centre - The AIM Centre - Merewether
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Recruitment hospital [2]
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St Vincent's Hospital - Fitzroy
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Recruitment hospital [3]
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The Austin Hospital - Heidelberg
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Recruitment hospital [4]
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The Royal Melbourne Hospital - Parkville
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Recruitment hospital [5]
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Sunshine Hospital - St Albans
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Recruitment hospital [6]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment postcode(s) [1]
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2291 - Merewether
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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3052 - Parkville
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Recruitment postcode(s) [5]
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3021 - St Albans
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Recruitment postcode(s) [6]
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5112 - Elizabeth Vale
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Hawaii
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Country [4]
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United States of America
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State/province [4]
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Louisiana
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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Missouri
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Country [7]
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United States of America
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State/province [7]
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Nevada
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Country [8]
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United States of America
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State/province [8]
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New York
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Country [9]
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United States of America
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State/province [9]
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North Carolina
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Country [10]
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United States of America
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State/province [10]
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Tennessee
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Country [11]
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United States of America
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State/province [11]
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Texas
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Country [12]
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Canada
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State/province [12]
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Ontario
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Country [13]
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Israel
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State/province [13]
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Re?ovot
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Country [14]
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Israel
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State/province [14]
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Tel Aviv-Yafo
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Country [15]
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New Zealand
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State/province [15]
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Auckland
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Country [16]
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New Zealand
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State/province [16]
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Christchurch
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Country [17]
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New Zealand
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State/province [17]
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Wellington
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Country [18]
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Puerto Rico
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State/province [18]
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San Juan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
CSL Behring
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This phase 2a, double-blind, randomized, placebo-controlled study will assess the efficacy,
safety, tolerability, and pharmacokinetics (PK), of repeat doses of CSL346 in subjects with
diabetic kidney disease (DKD) and albuminuria receiving standard of care treatment.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04419467
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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CSL Behring
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04419467
Download to PDF