A Phase 2b / 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis

Trial tests CSL300 for heart risks in dialysis patients

NCT: NCT05485961 · Status: RECRUITING · Phase: Phase 3 · Sponsor: CSL Behring · Started: 2022-10-21 · Est. Completion: 2029-09-27

Plain English Summary

Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis is a Phase 3 clinical trial sponsored by CSL Behring studying Atherosclerotic Cardiovascular Disease, End Stage Kidney Disease, Atherosclerotic Cardiovascular Disease in Patients With ESKD. This study is testing if a drug called CSL300 can lower the risk of heart problems in adults with severe kidney disease who are on dialysis. It is for adults with end-stage kidney disease who have been on dialysis for at least 12 weeks and have signs of inflammation. Participants will receive either CSL300 or a placebo (a dummy treatment) through an IV, and will be monitored for about 5 years. There are no specific alternative treatments mentioned for participation in this trial, but standard dialysis care will continue. The trial aims to enroll 2310 participants.

Official Summary

This is a 2-part (phase 2b/3) prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1 (phase 2b) is a dose-finding study for CSL300 vs placebo. Part 2 (phase 3) aims to assess the efficacy of CSL300 on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 18 or older, have end-stage kidney disease requiring dialysis for over 12 weeks, and have specific markers of inflammation in your blood. You must also have diabetes or a history of heart disease. You cannot join if you participated in the earlier part of this study, are taking certain immune-suppressing drugs, have liver problems, or have a serious illness that is expected to be fatal within a year. This trial is studying Atherosclerotic Cardiovascular Disease, End Stage Kidney Disease, Atherosclerotic Cardiovascular Disease in Patients With ESKD, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if CSL300 can prevent major heart events like heart attacks or death from heart causes over approximately 5 years. The specific primary outcome measures are: Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b) (Baseline and up to 12 weeks); Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3) (Approximately 5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a critical need to reduce cardiovascular complications, a leading cause of death, in patients with end-stage kidney disease undergoing dialysis. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Atherosclerotic Cardiovascular Disease, End Stage Kidney Disease, Atherosclerotic Cardiovascular Disease in Patients With ESKD, where improved treatment options are needed.

Investor Insight

This large-scale outcome study signals strong investor confidence in CSL300's potential to address a significant unmet need in a large patient population, suggesting a potentially high probability of Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 2310 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of CSL300 and what it means to be on dialysis. Understand that you will receive either the study drug or a placebo, and your treatment will be closely monitored. Be prepared for regular clinic visits and tests over a period of about 5 years. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* \- Male or female at least 18 years of age
* \- A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks
* \- Serum hs-CRP ≥ 2.0 mg/L
* \- A diagnosis of diabetes mellitus OR ASCVD

Exclusion Criteria:

* \- Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3)
* \- Concomitant use of systemic immunosuppressant drugs
* \- Abnormal LFTs
* \- Any life-threatening disease expected to result in death within 12 months
* \- A history of GI perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease
* -Clinically significant active infection or history of opportunistic or invasive fungal infection

Trial Locations

Frequently Asked Questions

What is clinical trial NCT05485961?

NCT05485961 is a Phase 3 INTERVENTIONAL study titled "Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis." It is currently recruiting and is sponsored by CSL Behring. The trial targets enrollment of 2310 participants.

What conditions does NCT05485961 study?

This trial investigates treatments for Atherosclerotic Cardiovascular Disease, End Stage Kidney Disease, Atherosclerotic Cardiovascular Disease in Patients With ESKD. The primary condition under study is Atherosclerotic Cardiovascular Disease.

What treatments are being tested in NCT05485961?

The interventions being studied include: CSL300 (DRUG), Placebo (DRUG). IV administration

What does Phase 3 mean for NCT05485961?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT05485961?

This trial is currently "Recruiting." It started on 2022-10-21. The estimated completion date is 2029-09-27.

Who is sponsoring NCT05485961?

NCT05485961 is sponsored by CSL Behring. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05485961?

The trial aims to enroll 2310 participants. The trial is currently recruiting and accepting new participants.

How is NCT05485961 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT05485961?

The primary outcome measures are: Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b) (Baseline and up to 12 weeks); Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3) (Approximately 5 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05485961 being conducted?

This trial is being conducted at 20 sites, including Decatur, Alabama; Huntsville, Alabama; Montgomery, Alabama; Glendale, Arizona and 16 more sites (United States).

Where can I find official information about NCT05485961?

The official record for NCT05485961 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05485961. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05485961 testing in simple terms?

This study is testing if a drug called CSL300 can lower the risk of heart problems in adults with severe kidney disease who are on dialysis. It is for adults with end-stage kidney disease who have been on dialysis for at least 12 weeks and have signs of inflammation.

Why is this trial significant?

This trial addresses a critical need to reduce cardiovascular complications, a leading cause of death, in patients with end-stage kidney disease undergoing dialysis. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT05485961?

The most common side effects may include reactions at the injection site, and potential risks associated with weakening the immune system. As with any study drug, there's a possibility of unexpected side effects that are not yet known. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05485961?

Ask your doctor about the potential benefits and risks of CSL300 and what it means to be on dialysis. Understand that you will receive either the study drug or a placebo, and your treatment will be closely monitored. Be prepared for regular clinic visits and tests over a period of about 5 years. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05485961 signal from an investment perspective?

This large-scale outcome study signals strong investor confidence in CSL300's potential to address a significant unmet need in a large patient population, suggesting a potentially high probability of This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participants will receive either CSL300 or a placebo (a dummy treatment) through an IV, and will be monitored for about 5 years. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.