MedTrace Logo

A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment

NCT03226899 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2021-11-04

Study results available
· View outcomes & findings →

Summary

This study evaluates the safety and efficacy of lesinurad administered with an XOI versus a placebo plus an XOI in gout participants who have moderate renal impairment and who are not at target level of serum urate (sUA).

Conditions

  • Gout
  • Chronic Kidney Disease (CKD)

Interventions

DRUG

Lesinurad

200 mg oral tablet

DRUG

XOI

All participants must be on a stable, medically appropriate dose of XOI as their sole urate-lowering therapy (ULT) indicated for the treatment of gout for at least 4 weeks prior to Screening and throughout the Screening Period. This stable dose of XOI will be maintained throughout the study period.

DRUG

Placebo

matching placebo oral tablet

DRUG

colchicine

Gout flare prophylaxis: commercially available colchicine is provided through the Month 6 study visit. Actual colchicine dose (0.5 or 0.6 mg qd) and frequency were adjusted based on the local label, subject medical history, and clinical judgement.

DRUG

corticosteroids

Gout flare prophylaxis: Participants unable to take colchicine are permitted to take a short course of low-dose oral corticosteroids up to the Month 3 study visit

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Ironwood Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Ironwood Study Chair · Ironwood Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-19
Primary Completion
2019-02-25
Completion
2019-02-25
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Hungary
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03226899 on ClinicalTrials.gov