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NCT05485961RECRUITINGIRB Ready

Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis

(POSIBIL6ESKD)

Sponsored by CSL Behring

Quick Self-Assessment

See if you qualify and express your interest

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Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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

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 โ‰ฅ 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

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

2310 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

CSL Behring

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Decatur

Alabama

Location available
View Decatur location page
RECRUITING

Huntsville

Alabama

Location available
View Huntsville location page
RECRUITING

Montgomery

Alabama

Location available
View Montgomery location page
RECRUITING

Glendale

Arizona

Location available
View Glendale location page
RECRUITING

Glendale

Arizona

Location available
View Glendale location page
RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
RECRUITING

Tucson

Arizona

Location available
View Tucson location page
RECRUITING

Tucson

Arizona

Location available
View Tucson location page
RECRUITING

Bakersfield

California

Location available
View Bakersfield location page

๐Ÿ“ And 147 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for End Stage Kidney Disease Treatment in Huntsville?

Join others in Alabama exploring innovative treatment options through clinical research

End Stage Kidney Disease Treatment Options in Huntsville, Alabama

If you're searching for End Stage Kidney Disease treatment in Huntsville, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Huntsville, Montgomery, Glendale and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with End Stage Kidney Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 2310 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for End Stage Kidney Disease?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for End Stage Kidney Disease

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This End Stage Kidney Disease Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05485961. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.