Trial Outcomes & Findings for 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) (NCT NCT04655027)
NCT ID: NCT04655027
Last Updated: 2024-04-22
Results Overview
The main effect of roxadustat versus rHuEPO on GI iron absorption was evaluated.
COMPLETED
PHASE4
25 participants
From Baseline (Day 1) to Day 15
2024-04-22
Participant Flow
The study was conducted in 25 subjects at 8 clinical sites in China, of which 5 sites enrolled patients from 17 March 2021 (first subject first randomized) to 12 October 2021 (last subject last visit).
The screening period was up to 3 weeks. All the study assessments were performed as per the schedule of assessment. Eligible patients were randomized at a 1:1 ratio to receive either Roxadustat or rHuEPO \[Recombinant Human Erythropoietin\] for 14 days starting from Day 1.
Participant milestones
| Measure |
Roxadustat
Patients received oral dose of Roxadustat tablets three times a week (TIW) for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
rHuEPO
Patients received uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Roxadustat
Patients received oral dose of Roxadustat tablets three times a week (TIW) for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
rHuEPO
Patients received uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
|---|---|---|
|
Overall Study
Failure to meet inclusion/exclusion criteria/ Due to COVID-19 pandemic
|
1
|
0
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Roxadustat
n=13 Participants
Patients received oral dose of Roxadustat tablets three times a week (TIW) for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
rHuEPO
n=12 Participants
Patients received uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 Years
STANDARD_DEVIATION 12.09 • n=5 Participants
|
52.8 Years
STANDARD_DEVIATION 12.64 • n=7 Participants
|
55.1 Years
STANDARD_DEVIATION 12.32 • n=5 Participants
|
|
Age, Customized
≥ 18 to < 50 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Customized
≥ 50 to < 65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 to < 75 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Customized
≥ 75 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) to Day 15Population: The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis. Here, the number analyzed signified only the subjects with available data that were evaluated on that specific group.
The main effect of roxadustat versus rHuEPO on GI iron absorption was evaluated.
Outcome measures
| Measure |
Roxadustat
n=12 Participants
Patients received oral dose of Roxadustat tablets three times a week (TIW) for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
rHuEPO
n=11 Participants
Patients received uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
|---|---|---|
|
Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours)
Change from baseline
|
11.288 gram*3hours/deciliter (g*3hr/dL)
Standard Deviation 28.1506
|
-0.259 gram*3hours/deciliter (g*3hr/dL)
Standard Deviation 9.7369
|
|
Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours)
Hemodialysis (HD) group- Change from baseline
|
20.125 gram*3hours/deciliter (g*3hr/dL)
Standard Deviation 29.9536
|
-1.625 gram*3hours/deciliter (g*3hr/dL)
Standard Deviation 10.2189
|
|
Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours)
Peritoneal dialysis (PD)- Change from baseline
|
-2.408 gram*3hours/deciliter (g*3hr/dL)
Standard Deviation 19.4973
|
-2.263 gram*3hours/deciliter (g*3hr/dL)
Standard Deviation 6.7321
|
|
Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours)
Non-dialysis-dependent (NDD)- Change from baseline
|
34.700 gram*3hours/deciliter (g*3hr/dL)
Standard Deviation 39.8808
|
15.950 gram*3hours/deciliter (g*3hr/dL)
Standard Deviation NA
As only 1 participant was evaluable, hence SD was not calculable.
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Day 15Population: The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis. Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure. The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing.
The effect and interaction with key baseline variables of roxadustat versus rHuEPO on iron absorption was assessed.
Outcome measures
| Measure |
Roxadustat
n=12 Participants
Patients received oral dose of Roxadustat tablets three times a week (TIW) for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
rHuEPO
n=11 Participants
Patients received uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
|---|---|---|
|
Difference From Baseline to Day 15 in Area Under Curve (AUC) of Iron Absorption (0-3 Hours)
|
11.288 gram*3hours/deciliter (g*3hr/dL)
Standard Deviation 28.1506
|
-0.259 gram*3hours/deciliter (g*3hr/dL)
Standard Deviation 9.7369
|
SECONDARY outcome
Timeframe: From baseline (Day 1) to Day 15Population: The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis. Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure. The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing.
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: serum iron was assessed.
Outcome measures
| Measure |
Roxadustat
n=13 Participants
Patients received oral dose of Roxadustat tablets three times a week (TIW) for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
rHuEPO
n=11 Participants
Patients received uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
|---|---|---|
|
Difference From Baseline to Day 15 in Serum Iron
|
2.077 micromole/Liter (µmol/L)
Standard Deviation 7.9263
|
-0.845 micromole/Liter (µmol/L)
Standard Deviation 7.6225
|
SECONDARY outcome
Timeframe: From baseline (Day 1) to Day 15Population: The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis. Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure. The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing.
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Ferritin was assessed.
Outcome measures
| Measure |
Roxadustat
n=13 Participants
Patients received oral dose of Roxadustat tablets three times a week (TIW) for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
rHuEPO
n=11 Participants
Patients received uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
|---|---|---|
|
Difference From Baseline to Day 15 in Ferritin
|
-49.354 microgram/Liter (µg/L)
Standard Deviation 175.3039
|
-43.536 microgram/Liter (µg/L)
Standard Deviation 79.3449
|
SECONDARY outcome
Timeframe: From baseline (Day 1) to Day 15Population: The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis. Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure. The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing.
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: TIBC was assessed.
Outcome measures
| Measure |
Roxadustat
n=13 Participants
Patients received oral dose of Roxadustat tablets three times a week (TIW) for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
rHuEPO
n=10 Participants
Patients received uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
|---|---|---|
|
Difference From Baseline to Day 15 in Total Iron Binding Capacity (TIBC)
|
8.638 micromole/Liter (µmol/L)
Standard Deviation 5.1118
|
-0.490 micromole/Liter (µmol/L)
Standard Deviation 3.7784
|
SECONDARY outcome
Timeframe: From baseline (Day 1) to Day 15Population: The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis. Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure. The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing.
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: TSAT (fraction of TIBC) was assessed.
Outcome measures
| Measure |
Roxadustat
n=13 Participants
Patients received oral dose of Roxadustat tablets three times a week (TIW) for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
rHuEPO
n=10 Participants
Patients received uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
|---|---|---|
|
Relative Difference From Baseline to Day 15 in Transferrin Saturation (TSAT)
|
-0.024 Ratio
Standard Deviation 0.1806
|
-0.030 Ratio
Standard Deviation 0.2007
|
SECONDARY outcome
Timeframe: From baseline (Day 1) to Day 15Population: The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis. Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure. The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing.
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Transferrin was assessed.
Outcome measures
| Measure |
Roxadustat
n=13 Participants
Patients received oral dose of Roxadustat tablets three times a week (TIW) for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
rHuEPO
n=12 Participants
Patients received uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
|---|---|---|
|
Difference From Baseline to Day 15 in Transferrin
|
0.452 gram/Liter (g/L)
Standard Deviation 0.3550
|
-0.012 gram/Liter (g/L)
Standard Deviation 0.1393
|
SECONDARY outcome
Timeframe: From baseline (Day 1) to Day 15Population: The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis. Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure. The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing.
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Soluble transferrin receptor was assessed.
Outcome measures
| Measure |
Roxadustat
n=13 Participants
Patients received oral dose of Roxadustat tablets three times a week (TIW) for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
rHuEPO
n=12 Participants
Patients received uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
|---|---|---|
|
Difference From Baseline to Day 15 in Soluble Transferrin Receptor
|
1.876 milligram/Liter (mg/L)
Standard Deviation 3.0627
|
0.466 milligram/Liter (mg/L)
Standard Deviation 0.5556
|
SECONDARY outcome
Timeframe: From baseline (Day 1) to Day 15Population: The FAS was the primary efficacy analysis set and included all randomized patients who completed baseline (Day 1) measurements for any efficacy analysis. Here, the number analyzed signified only the subjects with available data that were evaluated for this specific outcome measure. The change from baseline reported uses observed values only, which is only defined when both Baseline and Day 15 values are non-missing.
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of Hepcidin was assessed.
Outcome measures
| Measure |
Roxadustat
n=13 Participants
Patients received oral dose of Roxadustat tablets three times a week (TIW) for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
rHuEPO
n=12 Participants
Patients received uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
|---|---|---|
|
Difference From Baseline to Day 15 in Hepcidin
|
-78.769 microgram/Liter (µg/L)
Standard Deviation 87.9264
|
-44.239 microgram/Liter (µg/L)
Standard Deviation 88.2325
|
SECONDARY outcome
Timeframe: From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)Population: The Safety analysis set included all randomized patients who received at least 1 dose of study treatment, with patients being analyzed as treated, rather than as randomized.
AEs as variables of safety was assessed.
Outcome measures
| Measure |
Roxadustat
n=13 Participants
Patients received oral dose of Roxadustat tablets three times a week (TIW) for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
rHuEPO
n=12 Participants
Patients received uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
|---|---|---|
|
Number of Subjects With Adverse Events (AEs)
Any AE
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Any AE with outcome of death
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Any Serious Adverse event (SAE) (including events with outcome of death)
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Any AE leading to discontinuation of study treatment
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Any AE leading to dose interruption
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Any AE leading to dose reduction
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Any AE leading to dose escalation
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Any AE leading to withdrawal from study
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Any AE possibly related to study treatment
|
1 Participants
|
0 Participants
|
Adverse Events
Roxadustat
rHuEPO
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Roxadustat
n=13 participants at risk
Patients received oral dose of Roxadustat tablets three times a week (TIW) for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
rHuEPO
n=12 participants at risk
Patients received uniform brand of short acting intravenous or subcutaneous dose of rHuEPO two times a week (BIW) or TIW based upon their previous dose of rHuEPO for 2 weeks during treatment period and followed 4 weeks of follow up period.
|
|---|---|---|
|
Infections and infestations
Abdominal infection
|
7.7%
1/13 • From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
|
0.00%
0/12 • From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.7%
1/13 • From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
|
16.7%
2/12 • From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
7.7%
1/13 • From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
|
0.00%
0/12 • From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
|
|
Nervous system disorders
Seizure
|
7.7%
1/13 • From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
|
0.00%
0/12 • From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
|
|
Eye disorders
Open angle glaucoma
|
7.7%
1/13 • From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
|
0.00%
0/12 • From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
|
0.00%
0/12 • From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
1/13 • From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
|
0.00%
0/12 • From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical study Information Center
Results disclosure agreements
- Principal investigator is a sponsor employee This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
- Publication restrictions are in place
Restriction type: OTHER