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)

Conditions

• Autosomal Recessive Polycystic Kidney (ARPKD)

Eligibility Criteria

Sex

ALL

Age

28 Days - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Tolvaptan Suspension — DRUG
  Syrup
• Tolvaptan Tablets — DRUG
  Tolvaptan (OPC-41061) Tolvaptan tablets will be administered orally as split-dose regimens (15/7.5 mg, 30/15 mg, and 45/15 mg) upon awakening and 8 hours later (twice daily) based on weight if able to swallow tablets.

Study Details

To evaluate the safety of tolvaptan in pediatric subjects with ARPKD

Key Dates

Start date

Jan 23, 2023

Status verified

Feb 2026

Primary completion

Jul 31, 2028

Completion

Aug 14, 2028

Study Design

Enrollment

20 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tolvaptan Suspension
  Tolvaptan suspension will be administered orally or via feeding/nasogastric tube at doses of 0.15 mg/kg once daily in the AM, 0.30 mg/kg once daily in the AM, 0.5 mg/kg once daily in the AM, 0.75 mg/kg split dose (0.5 mg/kg AM and 0.25 mg/kg 8 hours later), and 1 mg/kg split dose (0.67 mg/kg AM and 0.33 mg/kg 8 hours later) based on age. Treatment duration is 18 months.
• Experimental: Tolvaptan Tablets
  Tolvaptan tablets will be administered orally as split-dose regimens (15/7.5 mg, 30/15 mg, and 45/15 mg) upon awakening and 8 hours later (twice daily) based on weight if able to swallow tablets. Treatment duration is 18 months.

Primary Outcome Measure

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Enrollment up to 7 days post last dose ]

Central Contacts

• Otsuka Call Center
  844-687-8522
  [email protected]

Locations (12)

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