Washington Dc, DCNCT04782258Now EnrollingIRB Ready

Polycystic Kidney Disease Clinical Trial in Washington Dc, DC

Access cutting-edge polycystic kidney disease treatment through this phase 3 clinical trial at a research site in Washington Dc. Study-provided care at no cost to qualified participants.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.

Quick Self-Assessment

See if you qualify for this Washington Dc location

Preparing your pre-screening questions…

Expert Care in Washington Dc

Access polycystic kidney disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related polycystic kidney disease treatment provided free

Apply for This Washington Dc Location

Check if you qualify for this polycystic kidney disease clinical trial in Washington Dc, DC

Secure & Confidential

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

Why Participate?

  • No-Cost Study Care

  • Local to Washington Dc

    Convenient for DC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Washington Dc site if eligible
  4. 4Begin participation

About This Polycystic Kidney Disease Study in Washington Dc

To evaluate the safety of tolvaptan in pediatric subjects with ARPKD

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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.
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 (≤ 32 weeks gestational age) for infants 28 days to \< 12 weeks of age.
Anuria or RRT defined as intermittent or continuous hemodialysis, peritoneal dialysis, hemofiltration, hemodiafiltration or history of kidney transplantation.
Evidence of syndromic conditions associated with renal cysts (other than ARPKD).
Abnormal liver function tests including ALT and AST, \> 1.2 × ULN (upper limit of normal).
Has splenomegaly or portal hypertension (HTN).
Parents with renal cystic disease.
Receiving chronic diuretic that could not be adjusted after tolvaptan initiation.
Cannot be monitored for fluid balance.
Has or at risk of having sodium and potassium electrolyte imbalances, as determined by the investigator.
Has or at risk of having significant hypovolemia as determined by investigator.
Clinically significant anemia, as determined by investigator.
Platelets \< 50000 µL.
Severe systolic dysfunction defined as ejection fraction \< 14%.
Serum sodium levels \< 130 mmol/L or \>145 mmol/L.
Taking any other experimental medications.
Require ventilator support.
Taking medications known to induce CYP3A4 (CYP = Cytochrome P).
Having an infection including viral that would require therapy disruptive to IMP (Investigational Medicinal Product) dosing.
Females who are breast-feeding or who have a positive pregnancy test result prior to receiving IMP.
Subjects with a history of substance abuse (within the last 6 months).
Subjects who have bladder dysfunction and/or difficulty voiding.
Subjects taking a vasopressin agonist (eg, desmopressin).
Subjects with a history of persistent noncompliance with antihypertensive or other important medical therapy.
Subjects taking medications or having concomitant illnesses likely to confound endpoint assessments, including taking approved (ie, marketed) therapies for the purpose of affecting PKD cysts such as tolvaptan, vasopressin antagonists, anti-sense ribonucleic acid (RNA) therapies, rapamycin, sirolimus, everolimus, or somatostatin analogs (ie, octreotide, sandostatin).
Received or are scheduled to receive a liver transplant.
History of cholangitis within the last 6 months.
Has findings consistent with clinically significant portal hypertension (eg, varices, variceal bleeding, hypersplenism indicated by thrombocytopenia).
Subjects who do not agree to remain abstinent or assent to use a combination of 2 of the following highly effective birth control methods for at least 28 days before the first dose of IMP, during the trial (including during IMP dose interruptions), and for at least 30 days after the last dose of IMP:
Barrier method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide
Intrauterine device
Hormone-based contraceptives which are associated with inhibition of ovulation.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Washington Dc?

Yes, this clinical trial (NCT04782258) has an active research site in Washington Dc, DC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

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

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

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

Polycystic Kidney Disease Treatment Options in Washington Dc, DC

If you're searching for polycystic kidney disease treatment options in Washington Dc, DC, this clinical trial (NCT04782258) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Washington Dc research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced polycystic kidney disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all polycystic kidney disease clinical trials near you to find additional studies recruiting in your area.

More Ankylosing Spondylitis Trials in Washington Dc, DC

See all ankylosing spondylitis clinical trials recruiting in Washington Dc — not just this study.

Browse Ankylosing Spondylitis Trials in Washington Dc →

Browse More Trials by Condition

Ankylosing Spondylitis TrialsInterstitial Cystitis TrialsPolycystic Kidney Disease TrialsAll Conditions →

Ready to Join in Washington Dc?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Washington Dc, DC