← Back to Search

Monoclonal Antibody

CSL346 for Diabetic Kidney Disease

Phase 2
Waitlist Available
Research Sponsored by CSL Behring
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 minutes after the iv loading dose for csl346
Awards & highlights

Study Summary

This trial will study whether CSL346 is effective, safe, and tolerated in patients with diabetic kidney disease who are receiving standard care treatment.

Eligible Conditions
  • Diabetic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 120 minutes after the iv loading dose for csl346
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 minutes after the iv loading dose for csl346 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR)
Secondary outcome measures
Area Under the Concentration-time Curve in First Dosing Interval
Cmax After First Subcutaneous (SC) Dose of CSL346 in Serum Samples
Maximum Concentration (Cmax) After Intravenous (IV) Loading Dose of CSL346 in Serum Samples
+13 more

Side effects data

From 2022 Phase 2 trial • 114 Patients • NCT04419467
17%
COVID-19
10%
Albuminuria
10%
Oedema peripheral
10%
Blood creatinine increased
10%
Arthralgia
7%
Upper respiratory tract infection
7%
Tooth infection
7%
Hyperkalaemia
7%
Constipation
7%
Acute kidney injury
7%
Back pain
7%
Dizziness
3%
Head injury
3%
Traumatic fracture
3%
Subdural abscess
3%
Urosepsis
3%
Pulmonary embolism
3%
Respiratory arrest
3%
C-reactive protein increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
CSL346 (Low Dose)
CSL346 (High Dose)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: CSL346 (low dose)Experimental Treatment1 Intervention
Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
Group II: CSL346 (high dose)Experimental Treatment1 Intervention
Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
Group III: PlaceboPlacebo Group1 Intervention
Administered as a single IV loading dose followed by SC infusions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CSL346
2020
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor
194 Previous Clinical Trials
1,211,108 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring
1,208 Previous Clinical Trials
489,581 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
Texas
How old are they?
18 - 65
What site did they apply to?
Riverside Nephrology Group
The Endocrine Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
2020. "Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04419467.
~25 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top