Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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
Layout table for location contacts
Contact: Trial Registration Coordinator 610-878-4000 clinicaltrials@cslbehring.com

Locations
Show Show 40 study locations
Sponsors and Collaborators
CSL Behring
Investigators
Layout table for investigator information
Study Director: Study Director CSL Behring
Layout table for additonal information
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.


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