Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
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
1 other identifier
interventional
114
6 countries
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2020
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2020
CompletedFirst Posted
Study publicly available on registry
June 5, 2020
CompletedStudy Start
First participant enrolled
September 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2022
CompletedResults Posted
Study results publicly available
December 6, 2023
CompletedDecember 6, 2023
December 1, 2023
2.1 years
June 3, 2020
October 24, 2023
December 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR)
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.
Baseline up to Week 16
Secondary Outcomes (16)
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Up to 24 weeks
Percentage of Subjects With TEAEs
Up to 24 weeks
Number of Subjects With Adverse Events of Special Interest (AESIs)
Up to 24 weeks
Percentage of Subjects With AESIs
Up to 24 weeks
Observed Value and Mean Change From Baseline in Serum Creatinine
Baseline up to 24 weeks
- +11 more secondary outcomes
Study Arms (3)
CSL346 (low dose)
EXPERIMENTALAdministered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
CSL346 (high dose)
EXPERIMENTALAdministered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
Placebo
PLACEBO COMPARATORAdministered as a single IV loading dose followed by SC infusions
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (37)
California Kidney Specialists (CKS) - Citrus Office
Covina, California, 91702, United States
Valley Research - Fresno
Fresno, California, 93720, United States
Torrance Clinical Research (TCR) - Lomita
Lomita, California, 90717, United States
Renal Medical Associate/NARI
Lynwood, California, 90260, United States
Amicis Research Center
Northridge, California, 91324, United States
California Medical Research Associates, Inc
Northridge, California, 91324, United States
Riverside Nephrology Group
Riverside, California, 92503, United States
West Orange Endocrinology
Ocoee, Florida, 34761, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Omega Clinical Research
Metairie, Louisiana, 70006, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Renal and Transplant Associates
Springfield, Massachusetts, 01107, United States
University of Missouri Health System
Columbia, Missouri, 65212, United States
Palm Medical Group, LLC - Las Vegas
Las Vegas, Nevada, 89148, United States
Center for Thyroid & Parathyroid Disorders
Staten Island, New York, 10301, United States
Physicians East, P.A. - Endocrinology
Greenville, North Carolina, 27834, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, 37232, United States
Juno Research, L.L.C.
Houston, Texas, 77040, United States
The Endocrine Center
Houston, Texas, 77079, United States
Renal Associates, P.A. - San Antonio
San Antonio, Texas, 78215, United States
Primary Care Providers of Texas
San Antonio, Texas, 78224, United States
Diabetes and Metabolism Specialists (DMS) - San Antonio
San Antonio, Texas, 78231, United States
Hunter Diabetes Centre - The AIM Centre
Merewether, New South Wales, 2291, Australia
St Vincent's Hospital
Fitzroy, Victoria, 3065, Australia
The Austin Hospital
Heidelberg, Victoria, 3084, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3052, Australia
Sunshine Hospital
St Albans, Victoria, 3021, Australia
Lyell McEwin Hospital
Elizabeth Vale, 5112, Australia
1240130 - University Health Network
Toronto, Ontario, M5G 2N2, Canada
3760045 - Kaplan Medical Center
Rehovot, 76100, Israel
3760044 - Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Middlemore Hospital
Auckland, 2025, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
Lipid and Diabetes Research Group
Christchurch, 8011, New Zealand
Endocrine Associates - Wellington
Wellington, 6140, New Zealand
Fundación de Investigación
San Juan, 00927, Puerto Rico
University of Puerto Rico - Puerto Rico Clinical and TRC
San Juan, 00935, Puerto Rico
Related Publications (1)
Cooper M, Cherney DZI, Greene TH, Heerspink HJL, Jardine M, Lewis JB, Wong MG, Baquero E, Heise M, Jochems J, Lanchoney D, Liss C, Reiser D, Scotney P, Velkoska E, Dwyer JP. Vascular Endothelial Growth Factor-B Blockade with CSL346 in Diabetic Kidney Disease: A Phase 2A Randomized Controlled Trial. J Am Soc Nephrol. 2024 Nov 1;35(11):1546-1557. doi: 10.1681/ASN.0000000000000438. Epub 2024 Aug 16.
PMID: 39150859DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- CSL Behring
Study Officials
- STUDY DIRECTOR
Study Director
CSL Behring
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2020
First Posted
June 5, 2020
Study Start
September 14, 2020
Primary Completion
October 24, 2022
Study Completion
October 24, 2022
Last Updated
December 6, 2023
Results First Posted
December 6, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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.
- Access Criteria
- 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.
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 clinicaltrials@cslbehring.com. 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.