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Monoclonal Antibodies

CSL300 for Kidney Failure

Phase 2 & 3

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

A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks

A diagnosis of diabetes mellitus OR ASCVD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

Study Summary

This trialwill study the safety & effectiveness of a drug (CSL300) for people with ESKD, systemic inflammation, & either ASCVD or diabetes.

Who is the study for?

Adults with end-stage kidney disease (ESKD) on dialysis for at least 12 weeks can join this trial. They must also have diabetes or atherosclerotic cardiovascular disease (ASCVD), and signs of inflammation shown by high hs-CRP levels. People who were in the earlier part of the study, have certain gastrointestinal conditions, use strong immune system drugs, or have abnormal liver tests cannot participate.Check my eligibility

What is being tested?

The study is testing CSL300 against a placebo to find the right dose and see if it helps with heart-related outcomes in patients with ESKD undergoing dialysis. It's organized into two parts: first finding the correct dosage and then checking its effectiveness and safety.See study design

What are the potential side effects?

Possible side effects may include reactions related to immune system suppression since CSL300 is likely an immunomodulatory drug. Specific side effects are not listed but could be similar to those seen with other drugs that affect the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on dialysis for my kidney failure for at least 12 weeks.

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I have been diagnosed with diabetes or heart and blood vessel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)

Time to first occurrence of CV death or MI (Phase 3)

Secondary outcome measures

Area under the plasma concentration versus time curve (AUC) for CSL300 (Phase 2b)

Change from baseline in log-transformed hs-CRP (Phase 2b)

Mean change from Baseline in ALT (Phase 2b)

+34 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: CSL300 (medium dose)(Phase 2b)Experimental Treatment1 Intervention

IV administration

Group II: CSL300 (low dose)(Phase 2b)Experimental Treatment1 Intervention

Intravenous (IV) administration

Group III: CSL300 (high dose)(Phase 2b)Experimental Treatment1 Intervention

IV administration

Group IV: CSL300 (Phase 3)Experimental Treatment1 Intervention

IV administration

Group V: Placebo (Phase 2b)Placebo Group1 Intervention

IV administration

Group VI: Placebo (Phase 3)Placebo Group1 Intervention

IV administration

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor

194 Previous Clinical Trials

1,208,912 Total Patients Enrolled

Study DirectorStudy DirectorCSL Behring LLC

1,208 Previous Clinical Trials

487,385 Total Patients Enrolled

2 Trials studying Kidney Failure

417 Patients Enrolled for Kidney Failure

Media Library

CSL300 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05485961 — Phase 2 & 3

Kidney Failure Research Study Groups: CSL300 (high dose)(Phase 2b), CSL300 (low dose)(Phase 2b), CSL300 (medium dose)(Phase 2b), Placebo (Phase 2b), CSL300 (Phase 3), Placebo (Phase 3)

CSL300 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05485961 — Phase 2 & 3

Kidney Failure Clinical Trial 2023: CSL300 Highlights & Side Effects. Trial Name: NCT05485961 — Phase 2 & 3

Frequently Asked Questions

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

Are there any opportunities for volunteer participation in this research?

"Per the latest information on clinicaltrials.gov, this investigation is actively enrolling patients; it was initially published in October of 2022 and its terms were most recently updated two months ago."

Answered by AI

What is the aggregate participation in this clinical experiment?

"Absolutely. According to the information on clinicaltrials.gov, this study is actively enrolling participants since it was first postedon October 21st 2022 and most recently updated on February 2nd 2023. The research team aims to have 2310 patients recruited from 1 site in total."

Answered by AI