Skip to content

Safety and efficacy of oral roxastat in the treatment of renal anemia after allogeneic kidney transplantation

A randomized controlled study of oral roxastatin in the treatment of renal anemia after allogeneic kidney transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063657
Enrollment
Unknown
Registered
2022-09-14
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Kidney transplant

Interventions

Test group:Rosastat,oral
Control group:Injection of erythropoietin

Sponsors

Renji Hospital affiliated to Shanghai Jiao Tong University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) 18-65 years old; 2) There are indications for kidney transplantation, and kidney transplantation is performed in three kidney transplantation centers; 3) The patients were diagnosed as renal anemia according to the Chinese clinical practice guide for the diagnosis and treatment of renal anemia (2021 Edition); ? Anemia is confirmed: hemoglobin (HB) of male is less than 130 g/l, and Hb of female is less than 120 g / L ? Ischemic or hemorrhagic diseases other than renal anemia are excluded, including dystrophic anemia, hemolytic anemia, hemorrhagic anemia, and blood system diseases 4) Patients' postoperative prescription data were complete; 5) Sign the informed consent form; 6) Regular follow-up; 7) Normal liver function; 8) Weight 40-100kg (included) 9) The subjects must agree not to use any new anemia drugs from the beginning of enrollment to the end of the follow-up period, nor change the dose, administration plan or brand of any anemia drugs used before enrollment.

Exclusion criteria

Exclusion criteria: 1) Combined multiple organ transplantation; 2) Those who use drugs in combination outside the specified range, especially those that have a great impact on the test results, such as intravenous iron, blood transfusion, etc., which affect the judgment of effectiveness and safety; 3) Participants in other clinical trials; 4) Previous history of other organ transplantation; 5) Failing to sign the informed consent; 6) Any clinically significant infection or active tumor, evidence of infection (including bacteria and viruses); 7) Chronic liver disease; 8) Patients who are expected to need blood transfusion; 9) Pregnant and lactating women; 10) The expected life is less than 12 months; Other circumstances that the researcher believes are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Scr;Hb;BUN;Urine protein;

Secondary

MeasureTime frame
Red blood cell count;Fe;eticulocyte count;ALT;AST;Direct bilirubin;total bilirubin;uric acid;LDL;HDL;TG;Incidence of rejection reactions and infections;

Countries

China

Contacts

Public ContactZhang Ming

Renji Hospital affiliated to Shanghai Jiao Tong University Medical College

15736875970@163.com02153882042

Outcome results

None listed

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