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A Study of Verinurad and Allopurinol in Patients With Chronic Kidney Disease and Hyperuricaemia

NCT03990363 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 861

Last updated 2023-03-02

Study results available
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Summary

The purpose of this clinical research study is to establish the dose of verinurad combined with allopurinol 300 mg once daily that will elicit the desired response; ie, reduction in urinary albumin to creatinine ratio (UACR) at 6 months.

Conditions

Interventions

DRUG

Verinurad

Study treatments will be titrated in 3 steps for target low dose (3 mg), intermediate dose ( 7.5 mg) and High Dose (12 mg) Verinurad. As per Protocol Version 5.0, Patients from 3 mg dose will be switched to 24 mg at visit 9

DRUG

Allopurinol

Study treatments will be titrated in 3 steps: Low dose (100 mg), intermediate (200 mg) and High Dose ( 300 mg) Allopurinol

DRUG

Placebo for Verinurad

Matching Capsule

DRUG

Placebo for Allopurinol

Matching tablet

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-07-23
Primary Completion
2021-11-22
Completion
2021-11-22
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Poland
  • Romania
  • Slovakia
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03990363 on ClinicalTrials.gov