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.
This is an open-label study, after eligibility confirmation patients will be randomized in a 1:1 ratio to either roxadustat or rHuEPO arms for 2 weeks. The study will enroll eligible dialysis and non-dialysis patients ≥18 years of age, who have anemia of CKD, and are either dialysis-dependent (DD) and on a stable dose of rHuEPO within 4 weeks prior to screening, or are non-dialysis-dependent (NDD) and are being treated with rHuEPO (ie, on a stable dose of rHuEPO within 4 weeks prior to screening), or are rHuEPO -naïve at the time of screening. Each patient will be contacted before the first Screening Visit (Visit 1) for the symptoms of coronavirus disease of 2019 (COVID-19) and for any contact with COVID-19 positive person within the past 14 days. For each patient, the duration of participation in the study will be approximately 8 to 9 weeks divided into 3 periods: Screening Period (approximately 2-3 weeks); Treatment Period (2 weeks) and Post-Treatment Follow-up Period (4 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
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.
Research Site
Baotou, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours)
The main effect of roxadustat versus rHuEPO on GI iron absorption was evaluated.
Time frame: From Baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Area Under Curve (AUC) of Iron Absorption (0-3 Hours)
The effect and interaction with key baseline variables of roxadustat versus rHuEPO on iron absorption was assessed.
Time frame: From Baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Serum Iron
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: serum iron was assessed.
Time frame: From baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Ferritin
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Ferritin was assessed.
Time frame: From baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Total Iron Binding Capacity (TIBC)
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: TIBC was assessed.
Time frame: From baseline (Day 1) to Day 15
Relative Difference From Baseline to Day 15 in Transferrin Saturation (TSAT)
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: TSAT (fraction of TIBC) was assessed.
Time frame: From baseline (Day 1) to Day 15
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Research Site
Guangzhou, China
Research Site
Jinan, China
Research Site
Shenyang, China
Research Site
Wuhan, China
Difference From Baseline to Day 15 in Transferrin
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Transferrin was assessed.
Time frame: From baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Soluble Transferrin Receptor
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of iron metabolism: Soluble transferrin receptor was assessed.
Time frame: From baseline (Day 1) to Day 15
Difference From Baseline to Day 15 in Hepcidin
The effect and interaction with baseline variables of roxadustat versus rHuEPO on the indices of Hepcidin was assessed.
Time frame: From baseline (Day 1) to Day 15
Number of Subjects With Adverse Events (AEs)
AEs as variables of safety was assessed.
Time frame: From screening (Starting on Day -21) until follow up (28 days) (approximately 7 weeks)