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Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease

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ClinicalTrials.gov Identifier: NCT04419467
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease (DKD) Biological: CSL346 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 14, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : February 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: CSL346 (low dose)
Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
 Biological: CSL346
VEGF-B antagonist monoclonal antibody
Experimental: CSL346 (high dose)
Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
 Biological: CSL346
VEGF-B antagonist monoclonal antibody
Placebo Comparator: Placebo
Administered as a single IV loading dose followed by SC infusions
 Drug: Placebo
Normal saline


Outcome Measures
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Primary Outcome Measures :
  1. Mean change in log-transformed urinary albumin-to-creatinine ratio (ACR) [ Time Frame: Baseline up to Week 16 ]

Secondary Outcome Measures :
  1. Number of subjects with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 24 weeks ]
  2. Percentage of subjects with TEAEs [ Time Frame: Up to 24 weeks ]
  3. Number of subjects with adverse events of special interest (AESIs) [ Time Frame: Up to 24 weeks ]
  4. Percentage of subjects with AESIs [ Time Frame: Up to 24 weeks ]
  5. Observed value and mean change from Baseline in serum creatinine [ Time Frame: Baseline up to 24 weeks ]
  6. Observed value and mean change from Baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline up to 24 weeks ]
  7. Observed value and mean change from Baseline in systolic blood pressure [ Time Frame: Baseline up to 24 weeks ]
  8. Observed value and mean change from Baseline in diastolic blood pressure [ Time Frame: Baseline up to 24 weeks ]
  9. Maximum concentration (Cmax) after IV loading dose of CSL346 in serum samples [ Time Frame: Up to 120 minutes after the IV loading dose for CSL346 ]
  10. Time to reach Cmax in serum (Tmax) after IV loading dose of CSL346 in serum samples [ Time Frame: Up to 120 minutes after the IV loading dose for CSL346 ]
  11. Cmax after first SC dose of CSL346 in serum samples [ Time Frame: From Day 1 to Day 29 ]
  12. Tmax after first SC dose of CSL346 in serum samples [ Time Frame: From Day 1 to Day 29 ]
  13. Area under the concentration-time curve in first dosing interval [ Time Frame: From Day 1 to Day 29 ]
  14. Trough concentration after each dose [ Time Frame: 29 days after each dose ]
  15. Number of subjects positive for anti-drug antibodies [ Time Frame: Weeks 4, 8, and 16 ]
  16. Percentage of subjects positive for anti-drug antibodies [ Time Frame: Weeks 4, 8, and 16 ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≥ 60 mL/min/1.73m2
  • Glycosylated HbA1c < 12%

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04419467


Contacts
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Contact: Trial Registration Coordinator 610-878-4000 clinicaltrials@cslbehring.com

Locations
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Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Study Director CSL Behring
More Information
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT04419467    
Other Study ID Numbers: CSL346_2001
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases