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

NCT04419467 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2023-12-06

Study results available
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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.

Conditions

  • Diabetic Kidney Disease (DKD)

Interventions

BIOLOGICAL

CSL346

VEGF-B antagonist monoclonal antibody

DRUG

Placebo

Normal saline

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Study Director · CSL Behring

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2022-10-24
Completion
2022-10-24
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Israel
  • New Zealand
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04419467 on ClinicalTrials.gov