# 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)

> **NCT04782258** · PHASE3 · RECRUITING · sponsor: **Otsuka Pharmaceutical Development & Commercialization, Inc.** · enrollment: 20 (estimated)

## Conditions studied

- Autosomal Recessive Polycystic Kidney (ARPKD)

## Interventions

- **DRUG:** Tolvaptan Suspension
- **DRUG:** Tolvaptan Tablets

## Key facts

- **NCT ID:** NCT04782258
- **Lead sponsor:** Otsuka Pharmaceutical Development & Commercialization, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2023-01-23
- **Primary completion:** 2028-07-31
- **Final completion:** 2028-08-14
- **Target enrollment:** 20 (ESTIMATED)
- **Last updated:** 2026-02-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04782258

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04782258, "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)". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT04782258. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*