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NCT05196035RECRUITINGIRB Ready

A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria

(FIONA)

Sponsored by Bayer

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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 6 months to \<18 years old at the time when the informed consent/assent is signed
Participants must have a clinical diagnosis of chronic kidney disease (CKD) at screening which is defined as
CKD stages 1-3 (eGFR β‰₯30 mL/min/1.73m\^2) for children β‰₯1 year to \<18 years of age or
a serum creatinine ≀ 0.40 mg/dL for infants 6 months to \< 1 year of age and
severely increased proteinuria as defined by
Urinary protein-to-creatinine ratio (UPCR) of β‰₯ 0.50 g/g in participants β‰₯ 2 years with CKD stage 2 and 3 or
UPCR β‰₯ 1.0 g/g for patients \< 2 years of age or β‰₯ 2 years of age and with CKD stage 1
Participants must have stable kidney function between screening and D0 defined as:
For participants with a creatinine of \> 0.8 mg/dL at screening: no increase or decrease in eGFR by β‰₯ 20% at D0
For participants with a creatinine of ≀ 0.8 mg/dL at screening: no increase or decrease in creatinine β‰₯ 0.15 mg/dL at D0.

❓ 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

219 participants

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Age Range

6 Months - 17 Years

⚧

Gender

ALL

🏒

Sponsor

Bayer

Study Locations

Choose your preferred location or select flexible during enrollment

TERMINATED

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
RECRUITING

San Diego

California

Location available
View San Diego location page
NOT_YET_RECRUITING

Washington D.C.

District of Columbia

Location available
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 10 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 219 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: NCT05196035. 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.