Tolvaptan Tablets for Autosomal Recessive Polycystic Kidney Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Autosomal Recessive Polycystic Kidney DiseaseTolvaptan Tablets - Drug
Eligibility
28 - 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety of tolvaptan, a drug used to treat ARPKD, in children.

Eligible Conditions
  • Autosomal Recessive Polycystic Kidney Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 1 month, 6 months, 12 months, and 18 months

Month 18
Change from baseline of eGFR (by Schwartz formula) while on treatment at Months 1, 6, 12, and 18
Day 7
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Month 18
Annual rate of change of eGFR (by Schwartz formula) from baseline to post-treatment after 18 months of treatment
Rate of change of eGFR (by Schwartz formula) from baseline to post-treatment after 18 months of treatment
The percentage of subjects that will receive renal replacement therapy (RRT) by 18 months.
Month 18
The amount of time between enrollment and 18 months that a subject requires renal replacement therapy (RRT).

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Tolvaptan Suspension
1 of 2
Tolvaptan Tablets
1 of 2

Experimental Treatment

10 Total Participants · 2 Treatment Groups

Primary Treatment: Tolvaptan Tablets · No Placebo Group · Phase 3

Tolvaptan Suspension
Drug
Experimental Group · 1 Intervention: Tolvaptan Suspension · Intervention Types: Drug
Tolvaptan Tablets
Drug
Experimental Group · 1 Intervention: Tolvaptan Tablets · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month, 6 months, 12 months, and 18 months

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
243 Previous Clinical Trials
164,612 Total Patients Enrolled
Rosa Real, MDStudy DirectorRosa.Real@otsuka-us.com
3 Previous Clinical Trials
117 Total Patients Enrolled
Natalia Agafonova, MDStudy Directornataliya.agafonova@otsuka-us.com
Olga Sergeyeva, MDStudy DirectorOlga.Sergeyeva@otsuka-us.com
1 Previous Clinical Trials
20 Total Patients Enrolled

Eligibility Criteria

Age 28 - 18 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a male or female minor between 28 days and 18 years old who exhibits the telltale signs of ARPKD.
You or your parent/legal guardian must provide written, informed consent before starting any trial-related activities, and you must be able to comply with all of the requirements of the trial