Efficacy and safety of rosastatin capsules in hemodialysis patients with erythropoietin resistance

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900026596

Enrollment

Unknown

Registered

2019-10-15

Start date

2019-10-22

Completion date

Unknown

Last updated

2019-10-21

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

Conditions

Hemodialysis combined with anemia

Interventions

experimental group:Oral rostastat capsule

control group:Recombinant human erythropoietin

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Aged 18-75 years; maintenance hemodialysis patients with erythropoietin resistance; voluntary informed consent. The erythropoietin resistance is defined as: when the iron reserve is sufficient, the hemoglobin is less than 100 g/L after 3 months of intravenous EPO > 450 IU/(kg.week) or subcutaneous injection of EPO > 300 IU/(kg.week).

Exclusion criteria

Exclusion criteria: Recently had upper digestive hemorrhage or other acute hemorrhagic disease; patients with hypersplenism; combined with blood system diseases such as myelodysplastic syndrome, multiple myeloma.

Design outcomes

Primary

Measure	Time frame
Monthly changes in hemoglobin;Hemoglobin compliance rate;Hemoglobin;	—

Secondary

Measure	Time frame
Ferritin;Transferrin saturation;Blood calcium;Blood phosphorus;Parathyroid hormone;albumin;Prealbumin;	—

Countries

China

Contacts

Public ContactZang Li

The First Affiliated Hospital of Chengdu Medical College

zangli2005917@163.com+86 18980661565

Outcome results

None listed

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