Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
NCT ID: NCT04419467
Last Updated: 2023-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
114 participants
INTERVENTIONAL
2020-09-14
2022-10-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CSL346 (low dose)
Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
CSL346
VEGF-B antagonist monoclonal antibody
CSL346 (high dose)
Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
CSL346
VEGF-B antagonist monoclonal antibody
Placebo
Administered as a single IV loading dose followed by SC infusions
Placebo
Normal saline
Interventions
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CSL346
VEGF-B antagonist monoclonal antibody
Placebo
Normal saline
Eligibility Criteria
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Inclusion Criteria
* Urinary ACR ≥ 150 mg/g
* eGFR \> 20 mL/min/1.73m2
* Glycosylated HbA1c \< 12%
Exclusion Criteria
* 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
25 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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California Kidney Specialists (CKS) - Citrus Office
Covina, California, United States
Valley Research - Fresno
Fresno, California, United States
Torrance Clinical Research (TCR) - Lomita
Lomita, California, United States
Renal Medical Associate/NARI
Lynwood, California, United States
Amicis Research Center
Northridge, California, United States
California Medical Research Associates, Inc
Northridge, California, United States
Riverside Nephrology Group
Riverside, California, United States
West Orange Endocrinology
Ocoee, Florida, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Omega Clinical Research
Metairie, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Renal and Transplant Associates
Springfield, Massachusetts, United States
University of Missouri Health System
Columbia, Missouri, United States
Palm Medical Group, LLC - Las Vegas
Las Vegas, Nevada, United States
Center for Thyroid & Parathyroid Disorders
Staten Island, New York, United States
Physicians East, P.A. - Endocrinology
Greenville, North Carolina, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, United States
Juno Research, L.L.C.
Houston, Texas, United States
The Endocrine Center
Houston, Texas, United States
Renal Associates, P.A. - San Antonio
San Antonio, Texas, United States
Primary Care Providers of Texas
San Antonio, Texas, United States
Diabetes and Metabolism Specialists (DMS) - San Antonio
San Antonio, Texas, United States
Hunter Diabetes Centre - The AIM Centre
Merewether, New South Wales, Australia
St Vincent's Hospital
Fitzroy, Victoria, Australia
The Austin Hospital
Heidelberg, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Lyell McEwin Hospital
Elizabeth Vale, , Australia
1240130 - University Health Network
Toronto, Ontario, Canada
3760045 - Kaplan Medical Center
Rehovot, , Israel
3760044 - Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Middlemore Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Lipid and Diabetes Research Group
Christchurch, , New Zealand
Endocrine Associates - Wellington
Wellington, , New Zealand
Fundación de Investigación
San Juan, , Puerto Rico
University of Puerto Rico - Puerto Rico Clinical and TRC
San Juan, , Puerto Rico
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CSL346_2001
Identifier Type: -
Identifier Source: org_study_id