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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04419467




Registration number
NCT04419467
Ethics application status
Date submitted
3/06/2020
Date registered
5/06/2020

Titles & IDs
Public title
Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
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
Secondary ID [1] 0 0
CSL346_2001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Kidney Disease (DKD) 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 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


Treatment: Other: CSL346
VEGF-B antagonist monoclonal antibody

Treatment: Drugs: Placebo
Normal saline
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR)
Timepoint [1] 0 0
Baseline up to Week 16
Secondary outcome [1] 0 0
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to 24 weeks
Secondary outcome [2] 0 0
Percentage of Subjects With TEAEs
Timepoint [2] 0 0
Up to 24 weeks
Secondary outcome [3] 0 0
Number of Subjects With Adverse Events of Special Interest (AESIs)
Timepoint [3] 0 0
Up to 24 weeks
Secondary outcome [4] 0 0
Percentage of Subjects With AESIs
Timepoint [4] 0 0
Up to 24 weeks
Secondary outcome [5] 0 0
Observed Value and Mean Change From Baseline in Serum Creatinine
Timepoint [5] 0 0
Baseline up to 24 weeks
Secondary outcome [6] 0 0
Observed Value and Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Timepoint [6] 0 0
Baseline up to 24 weeks
Secondary outcome [7] 0 0
Observed Value and Mean Change From Baseline in Systolic Blood Pressure
Timepoint [7] 0 0
Baseline up to 24 weeks
Secondary outcome [8] 0 0
Observed Value and Mean Change From Baseline in Diastolic Blood Pressure
Timepoint [8] 0 0
Baseline up to 24 weeks
Secondary outcome [9] 0 0
Maximum Concentration (Cmax) After Intravenous (IV) Loading Dose of CSL346 in Serum Samples
Timepoint [9] 0 0
Up to 120 minutes after the IV loading dose for CSL346
Secondary outcome [10] 0 0
Time to Reach Cmax in Serum (Tmax) After IV Loading Dose of CSL346 in Serum Samples
Timepoint [10] 0 0
Up to 120 minutes after the IV loading dose for CSL346
Secondary outcome [11] 0 0
Cmax After First Subcutaneous (SC) Dose of CSL346 in Serum Samples
Timepoint [11] 0 0
From Day 1 to Day 29
Secondary outcome [12] 0 0
Tmax After First SC Dose of CSL346 in Serum Samples
Timepoint [12] 0 0
From Day 1 to Day 29
Secondary outcome [13] 0 0
Area Under the Concentration-time Curve in First Dosing Interval
Timepoint [13] 0 0
From Day 1 to Day 29
Secondary outcome [14] 0 0
Trough Concentration After Each Dose
Timepoint [14] 0 0
29 days after each dose
Secondary outcome [15] 0 0
Number of Subjects Positive for Anti-drug Antibodies
Timepoint [15] 0 0
Weeks 4, 8, and 16
Secondary outcome [16] 0 0
Percentage of Subjects Positive for Anti-drug Antibodies
Timepoint [16] 0 0
Weeks 4, 8, and 16

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%
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/10/2022
Sample size
Target
Accrual to date
Final
114
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Hunter Diabetes Centre - The AIM Centre - Merewether
Recruitment hospital [2] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [3] 0 0
The Austin Hospital - Heidelberg
Recruitment hospital [4] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [6] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 0 0
2291 - Merewether
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment postcode(s) [5] 0 0
3021 - St Albans
Recruitment postcode(s) [6] 0 0
5112 - Elizabeth Vale
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Israel
State/province [13] 0 0
Re?ovot
Country [14] 0 0
Israel
State/province [14] 0 0
Tel Aviv-Yafo
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
New Zealand
State/province [16] 0 0
Christchurch
Country [17] 0 0
New Zealand
State/province [17] 0 0
Wellington
Country [18] 0 0
Puerto Rico
State/province [18] 0 0
San Juan

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
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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 requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at [email protected].

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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
Available to whom?
Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.

An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.

The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04419467