NCT03006445

Brief Summary

The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and ascending dose regimen.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2018

Completed
Last Updated

December 6, 2018

Status Verified

September 1, 2017

Enrollment Period

1.7 years

First QC Date

December 28, 2016

Last Update Submit

December 4, 2018

Conditions

Hyperuricemia With or Without Gout

Outcome Measures

Primary Outcomes (1)

  • Percent reduction from baseline in serum urate level at the final visit

    34 or 58 weeks

Study Arms (1)

FYU-981

EXPERIMENTAL
Drug: FYU-981

Interventions

FYU-981DRUG
FYU-981

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hyperuricemic or gout patients
  • Serum urate level:
  • \>= 7.0mg/dL in patients with history of gout, or \>= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or \>= 9.0mg/dL

You may not qualify if:

  • Gouty arthritis within two weeks before start of study treatment
  • Secondary hyperuricemia
  • HbA1c: \>= 8.4%
  • Uric acid-overproduction type in the classification of hyperuricemia
  • History of, clinically significant cardiac, hematologic and hepatic disease
  • Kidney calculi or clinically significant urinary calculi
  • eGFR: \< 30mL/min/1.73m\^2
  • Systolic blood pressure: \>= 180 mmHg
  • Diastolic blood pressure: \>= 110 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

Related Publications (2)

  • Takahashi T, Beppu T, Hosoya T, Yokota N. Changes in urinary albumin levels with dotinurad oral administration in hyperuricemic patients with microalbuminuria: a post hoc analysis. Clin Exp Nephrol. 2025 Oct;29(10):1384-1393. doi: 10.1007/s10157-025-02750-4. Epub 2025 Aug 21.

    PMID: 40839334DERIVED

  • Hosoya T, Fushimi M, Okui D, Sasaki T, Ohashi T. Open-label study of long-term administration of dotinurad in Japanese hyperuricemic patients with or without gout. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):80-91. doi: 10.1007/s10157-019-01831-5. Epub 2019 Dec 26.

    PMID: 31875931DERIVED

MeSH Terms

Interventions

dotinurad

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2016

First Posted

December 30, 2016

Study Start

December 1, 2016

Primary Completion

August 23, 2018

Study Completion

October 24, 2018

Last Updated

December 6, 2018

Record last verified: 2017-09

Locations

JP(1)