CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
Roxadustat +1 moredrug
Likely dose
Roxadustat 100 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/NCT04655027
NCT04655027Phase 4Completed
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ALTAI: An Open-Label, Randomized, Active-Controlled, Parallel Design, Multicenter Phase IV Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)

AstraZeneca·interventional·Posted Dec 4, 2020·Updated Apr 22, 2024

In Brief

A Phase 4 clinical trial evaluating Roxadustat and rHuEPO for Anemia of Chronic Kidney Disease. Completed, enrolled 25 participants across 8 sites.

Detailed Summary

This is a Phase IV, randomized, active-controlled, open-label, parallel design, multicenter prospective study to evaluate the effect of roxadustat versus rHuEPO treatment on the gastrointestinal (GI) iron absorption in patients with anemia of Stage 4 and Stage 5 CKD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia of Chronic Kidney Disease
CountriesChina
CollaboratorsParexel

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedDec 4, 2020
Enrollment StartFeb 22, 2021
Primary CompletionOct 12, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.6 years ago

Interventions

Roxadustatdrug

The starting dose of roxadustat will be in accordance with the China package insert, and will depend on the body weight of the patient: 100 mg (45 to \< 60 kg) or 120 mg (≥ 60 kg) in patients on dialysis; 70 mg (40 to \< 60 kg) or 100 mg (≥ 60 kg) in non-dialysis patients.

rHuEPOdrug

The starting dose of rHuEPO will be in accordance to the dosage approved in rHuEPO China package insert (patients on weekly dose of 6000 IU \[dosing will BIW\], and patients on weekly dose of \>6000 IU \[dosing will TIW\]) and on patient's haemoglobin levels.