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

Phase

Condition

Diabetic Kidney Disease

Treatment

N/A

Clinical Study ID

TX284445

CSL346_2001

Ages 25-80
All Genders

Study Summary

This is a prospective, multicenter, randomized, double-blind, placebo- controlled, proof of concept study to investigate the efficacy, safety, tolerability, and pharmacokinetics (PK) of repeat doses of CSL346 in 100 subjects with DKD and albuminuria receiving standard of care treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

- Are at least 25 years old
Have Type 2 Diabetes Mellitus and DKD
Have been taking certain medications for hypertension (high blood pressure) and for your kidneys for at least the past 2 months
Have NOT had chronic dialysis or kidney transplant
Have NOT had heart disease or heart surgery in the past 6 months

Exclusion

Exclusion Criteria:

Study Design

October 11, 2021

Study Description

Our site is taking part in the MANEUVER research study for people with Diabetic Kidney Disease (DKD) due to Type 2 Diabetes. This study is testing an investigational drug called CSL346 to see if it is safe and effective in treating DKD when added to the standard medicines you take. About 100 participants will join the study at approximately 40 research sites in Australia, New Zealand, and the United States.

The study consists of about 11 visits to our site over about 8 months for testing and monthly study drug injections. All study-related office visits, medical procedures, laboratory tests, and study drug are provided at no cost to qualified participants. Reimbursement for study-related time and travel may be provided; ask the study staff if this is available.

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Other requirements will be reviewed with you to determine if you may qualify.

Connect with a study center

South Florida Research Institute
Lauderdale Lakes, Florida 33313
United States
Active - Recruiting

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