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NCT05457283RECRUITINGIRB Ready

A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria

(FIONA OLE)

Sponsored by Bayer

Quick Self-Assessment

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πŸ“Š
1 of 100 participants interested
1% interest

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

Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a personΒ΄s kidneys leak protein into the urine. The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidneyΒ΄s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria.

Who Can Participate

Inclusion Criteria

Participants must be β‰₯1 year to 18 years of age, at the time of signing the informed consent/assent.
Prior participation in the finerenone Phase 3 study FIONA (19920) and not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA.
Participants must have a clinical diagnosis of chronic kidney disease (CKD) at Visit 1 which is defined as
CKD stages 1-3 (estimated glomerular filtration rate \[eGFR\] β‰₯30 mL/min/1.73m\^2) for children β‰₯1 year to \<19 years of age at FIONA EoT and at Visit 1
Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure (BP) management, unchanged for at least 30 days prior to Visit 1.
K+ ≀5.0 mmol/L for children β‰₯2 years of age at both FIONA EoT and Visit 1, and ≀5.3 mmol/L for children \<2 years of age at both FIONA EoT and V

❓ 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

100 participants

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Age Range

1 Year - 18 Years

⚧

Gender

ALL

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Sponsor

Bayer

Study Locations

Choose your preferred location or select flexible during enrollment

WITHDRAWN

Phoenix

Arizona

Location available
View Phoenix location page
WITHDRAWN

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

Palo Alto

California

Location available
View Palo Alto location page
NOT_YET_RECRUITING

San Diego

California

Location available
View San Diego location page
NOT_YET_RECRUITING

Washington D.C.

District of Columbia

Location available
NOT_YET_RECRUITING

Hollywood

Florida

Location available
View Hollywood location page
WITHDRAWN

Atlanta

Georgia

Location available
View Atlanta location page
NOT_YET_RECRUITING

Iowa City

Iowa

Location available
View Iowa City location page
RECRUITING

Baltimore

Maryland

Location available
View Baltimore location page

πŸ“ And 9 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

πŸ”’ Secure Β· πŸ₯ Expert Care

Looking for Chronic Kidney Disease Treatment in Phoenix?

Join others in Arizona exploring innovative treatment options through clinical research

Chronic Kidney Disease Treatment Options in Phoenix, Arizona

If you're searching for Chronic Kidney Disease treatment in Phoenix, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Phoenix, Los Angeles, Palo Alto 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 Chronic Kidney Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 100 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Chronic Kidney Disease?

Potential Benefits

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

What to Expect

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

Frequently Asked Questions About This Chronic 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: NCT05457283. 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.