NCT04655027

A 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)

Completed Phase 4 Results posted Last updated 22 April 2024

What this trial tests

Phase 4 trial testing Roxadustat in Anemia of Chronic Kidney Disease in 25 participants. Completed in 12 October 2021.

Timeline

22 February 2021

Primary endpoint
12 October 2021

12 October 2021

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	22 February 2021
Primary completion	12 October 2021
Estimated completion	12 October 2021
Sites	8 locations across China

Drugs / interventions tested

• Roxadustat (ROXADUSTAT) — full drug profile →
• rHuEPO — full drug profile →

Conditions studied

• Anemia of Chronic Kidney Disease — all drugs for Anemia of Chronic Kidney Disease →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Anemia of Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours) Primary · From Baseline (Day 1) to Day 15

The main effect of roxadustat versus rHuEPO on GI iron absorption was evaluated.

Change from baseline

Group	Value	95% CI
Roxadustat	11.288	± 28.1506
rHuEPO	-0.259	± 9.7369

Hemodialysis (HD) group- Change from baseline

Group	Value	95% CI
Roxadustat	20.125	± 29.9536
rHuEPO	-1.625	± 10.2189

Peritoneal dialysis (PD)- Change from baseline

Group	Value	95% CI
Roxadustat	-2.408	± 19.4973
rHuEPO	-2.263	± 6.7321

Non-dialysis-dependent (NDD)- Change from baseline

Group	Value	95% CI
Roxadustat	34.700	± 39.8808
rHuEPO	15.950	± NA

Difference From Baseline to Day 15 in Area Under Curve (AUC) of Iron Absorption (0-3 Hours) Secondary · From Baseline (Day 1) to Day 15

The effect and interaction with key baseline variables of roxadustat versus rHuEPO on iron absorption was assessed.

Group	Value	95% CI
Roxadustat	11.288	± 28.1506
rHuEPO	-0.259	± 9.7369

Difference From Baseline to Day 15 in Serum Iron Secondary · From baseline (Day 1) to Day 15

The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: serum iron was assessed.

Group	Value	95% CI
Roxadustat	2.077	± 7.9263
rHuEPO	-0.845	± 7.6225

Difference From Baseline to Day 15 in Ferritin Secondary · From baseline (Day 1) to Day 15

The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Ferritin was assessed.

Group	Value	95% CI
Roxadustat	-49.354	± 175.3039
rHuEPO	-43.536	± 79.3449

Difference From Baseline to Day 15 in Total Iron Binding Capacity (TIBC) Secondary · From baseline (Day 1) to Day 15

The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: TIBC was assessed.

Group	Value	95% CI
Roxadustat	8.638	± 5.1118
rHuEPO	-0.490	± 3.7784

Relative Difference From Baseline to Day 15 in Transferrin Saturation (TSAT) Secondary · From baseline (Day 1) to Day 15

The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: TSAT (fraction of TIBC) was assessed.

Group	Value	95% CI
Roxadustat	-0.024	± 0.1806
rHuEPO	-0.030	± 0.2007

Difference From Baseline to Day 15 in Transferrin Secondary · From baseline (Day 1) to Day 15

The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Transferrin was assessed.

Group	Value	95% CI
Roxadustat	0.452	± 0.3550
rHuEPO	-0.012	± 0.1393

Difference From Baseline to Day 15 in Soluble Transferrin Receptor Secondary · From baseline (Day 1) to Day 15

The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Soluble transferrin receptor was assessed.

Group	Value	95% CI
Roxadustat	1.876	± 3.0627
rHuEPO	0.466	± 0.5556

Difference From Baseline to Day 15 in Hepcidin Secondary · From baseline (Day 1) to Day 15

The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of Hepcidin was assessed.

Group	Value	95% CI
Roxadustat	-78.769	± 87.9264
rHuEPO	-44.239	± 88.2325

Number of Subjects With Adverse Events (AEs) Secondary · From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)

AEs as variables of safety was assessed.

Any AE

Group	Value	95% CI
Roxadustat	5
rHuEPO	2

Any AE with outcome of death

Group	Value	95% CI
Roxadustat	0
rHuEPO	0

Any Serious Adverse event (SAE) (including events with outcome of death)

Group	Value	95% CI
Roxadustat	0
rHuEPO	0

Any AE leading to discontinuation of study treatment

Group	Value	95% CI
Roxadustat	0
rHuEPO	0

Any AE leading to dose interruption

Group	Value	95% CI
Roxadustat	0
rHuEPO	0

Any AE leading to dose reduction

Group	Value	95% CI
Roxadustat	0
rHuEPO	0

Any AE leading to dose escalation

Group	Value	95% CI
Roxadustat	0
rHuEPO	0

Any AE leading to withdrawal from study

Group	Value	95% CI
Roxadustat	0
rHuEPO	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Roxadustat

Serious: 0/13 (0%)

Deaths: 0/13

rHuEPO

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (7 terms — click to expand)

Reaction	System	Roxadustat	rHuEPO
Hyperkalaemia	Metabolism and nutrition disorders	—	—
Abdominal infection	Infections and infestations	—	—
Hypermagnesaemia	Metabolism and nutrition disorders	—	—
Seizure	Nervous system disorders	—	—
Open angle glaucoma	Eye disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT04655027 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The efficacy and safety of roxadustat for the treatment of anemia in non-dialysis dependent chronic kidney disease patients: An updated systematic review and meta-analysis of randomized clinical trials.
   Abdelazeem B, Shehata J, Abbas KS, El-Shahat NA, et al · · 2022 · cited 15× · PMID 35363823 · DOI 10.1371/journal.pone.0266243
2. Roxadustat and Oral Iron Absorption in Chinese Patients with Anemia of Chronic Kidney Disease: A Randomized, Open-Label, Phase 4 Study (ALTAI).
   Wu H, Cheng H, Wang C, Yao L, et al · · 2024 · cited 5× · PMID 38280066 · DOI 10.1007/s12325-023-02741-5
3. A critical review of Roxadustat formulations, solid state studies, and analytical methodology.
   Mahajan R, Samanthula G, Srivastava S, Asthana A. · · 2023 · cited 3× · PMID 37346363 · DOI 10.1016/j.heliyon.2023.e16595