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Safety assessment of roxadustat in the treatment of renal anemia in dialysis patients: a retrospective study based on the ''Ruixiang Xinsheng'' patient assistance program

Safety assessment of roxadustat in the treatment of renal anemia in dialysis patients: a retrospective study based on the ''Ruixiang Xinsheng'' patient assistance program

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100048276
Enrollment
Unknown
Registered
2021-07-05
Start date
2021-07-05
Completion date
Unknown
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Anemia

Interventions

case series:Null

Sponsors

Beijing University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. All patients participating in the ''Ruixiang Xinsheng'' patient assistance program in the database of China Primary Health Care Foundation. 2. Patients diagnosed with CKD anemia and undergoing dialysis (including peritoneal dialysis and hemodialysis); 3. Hemoglobin <12g/dl; 4. There is no ESA concomitant medication, and patients who are receiving ESA treatment must have an appropriate withdrawal period (Such as ESA three times a week, 3000IU/time, stop for three days, such as ESA once a week, 10000IU/time, stop for 7 days).

Exclusion criteria

Exclusion criteria: 1. Those who participated in the ''Ruixiang Xinsheng'' patient assistance program in the database of China Primary Health Care Foundation without signing the informed consent; 2. Patients who have participated in the ''Ruixiang Xinsheng'' patient assistance program in the database of the China Primary Health Care Foundation without receiving the medicine; 3. Aged = 3 times the upper limit of the normal range (ULN) at the screening visit; 7. Total bilirubin >=2 times ULN at the screening visit; 8. Pregnant and lactating women; 9. Patients with poorly controlled hypertension identified by doctors; 10. A patient who is judged by a doctor to have a serious illness; 11. Patients with existing malignant tumors.

Design outcomes

Primary

MeasureTime frame
Adverse drug reactions during treatment;

Secondary

MeasureTime frame
Adverse effects among different subgroups;Serious adverse reactions;Adverse reactions in special populations;Adverse events of special concern;Hemoglobin level changes from baseline;Hemoglobin treatment compliance;

Countries

China

Contacts

Public ContactDong Jie

Peking University First Hospital

Jie.dong@bimu.edu.cn+86 13911841538

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026