CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 861 enrolled
Drug / intervention
Verinurad +3 moredrug
Likely dose
Verinurad 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03990363
NCT03990363Phase 2Completed

A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled Study of Verinurad and Allopurinol in Patients With Chronic KIdney Disease and Hyperuricaemia

AstraZeneca·interventional·Posted Jun 19, 2019·Updated Mar 2, 2023

In Brief

A Phase 2 clinical trial evaluating Verinurad, Allopurinol, and 2 other interventions for Chronic Kidney Disease. Completed, enrolled 861 participants across 165 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia, France, Hungary, Israel, Italy, Mexico, Poland, Romania, Slovakia, South Africa, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 19, 2019
Enrollment StartJul 23, 2019
Primary CompletionNov 22, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.0 years ago

Interventions

Verinuraddrug

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

Allopurinoldrug

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

Placebo for Verinuraddrug

Matching Capsule

Placebo for Allopurinoldrug

Matching tablet