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A Study to See Iftolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old withAutosomal Recessive Polycystic Kidney Disease (ARPKD)

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.

Quick Self-Assessment

See if you qualify and express your interest

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Feb 17, 2026

Phase

Clinical Trial

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Enrollment Target

20

Start Date

Jan 2023

๐Ÿ“Š
1 of 20 participants interested
5% 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

To evaluate the safety of tolvaptan in pediatric subjects with ARPKD

Who Can Participate

Inclusion Criteria

Male or female subjects between 28 days and less than 18 years of age, with clinical features that are consistent with a diagnosis of ARPKD. 2. Ability for parent/legal guardian to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial. Ability to provide written informed assent from all subjects old enough per local laws to provide assent.

Exclusion Criteria

Premature birth (โ‰ค 32 weeks gestational age) for infants 28 days to \< 12 weeks of age. 2. Anuria or RRT defined as intermittent or continuous hemodialysis, peritoneal dialysis, hemofiltration, hemodiafiltration or history of kidney transplantation. 3. Evidence of syndromic conditions associated with renal cysts (other than ARPKD). 4. Abnormal liver function tests including ALT and AST, \> 1.2 ร— ULN (upper limit of normal). 5. Has splenomegaly or portal hypertensi

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

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

20 participants

๐ŸŽ‚

Age Range

28 Days - 18 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Washington D.C.

District of Columbia

Location available
View Washington D.C. location page
WITHDRAWN

Atlanta

Georgia

Location available
View Atlanta location page
WITHDRAWN

Chicago

Illinois

Location available
View Chicago location page
WITHDRAWN

Indianapolis

Indiana

Location available
View Indianapolis location page
WITHDRAWN

New Orleans

Louisiana

Location available
View New Orleans location page
RECRUITING

Baltimore

Maryland

Location available
View Baltimore location page
RECRUITING

Ann Arbor

Michigan

Location available
View Ann Arbor location page
RECRUITING

Rochester

Minnesota

Location available
View Rochester location page
RECRUITING

Cincinnati

Ohio

Location available
View Cincinnati location page

๐Ÿ“ And 3 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?

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Looking for Polycystic Kidney Disease Treatment in Washington D.C.?

Join others in District of Columbia exploring innovative treatment options through clinical research

Polycystic Kidney Disease Treatment Options in Washington D.C., District of Columbia

If you're searching for Polycystic Kidney Disease treatment in Washington D.C., participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Washington D.C., Atlanta, Chicago 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 Polycystic Kidney Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in District of Columbia
Now Enrolling
Up to 20 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Polycystic 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 Polycystic 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 Polycystic 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: NCT04782258. 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.