ClinicaliQ Trial Snapshot
- A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD) — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT04782258.
- What is being tested: Tolvaptan (a vasopressin V2-receptor antagonist) is being evaluated for safety and pharmacodynamic effects in infants and children aged 28 days to <18 years with autosomal recessive polycystic kidney disease (ARPKD).
- Patient eligibility overview: The trial includes a broad pediatric population with confirmed ARPKD, spanning from neonates (28 days old) through adolescents, representing the full spectrum of age-related disease presentation in this rare genetic condition.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
To evaluate the pharmacodynamics and safety of tolvaptan in pediatric subjects with ARPKD
Eligibility Snapshot
- : 1. 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.