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A Randomized, controlled, open multicenter clinical trial for Recombinant Human Erythropoietin Injection (CHO cells) comparing for different doses weekly administration of renal anemia in maintenance hemodialysis

A Randomized, controlled, open multicenter clinical trial for Recombinant Human Erythropoietin Injection (CHO cells) comparing for different doses weekly administration of renal anemia in maintenance hemodialysis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022471
Enrollment
Unknown
Registered
2019-04-12
Start date
2019-04-12
Completion date
Unknown
Last updated
2019-04-15

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

Conditions

Renal anemia

Interventions

Treatment group:rhEPO 12000IU, once a week, was administered by i.v. injection
Control group:rhEPO 4000IU, three times a week, was administered by i.v. injection

Sponsors

First Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with maintenance hemodialysis, weekly dialysis time 12 h or more; 2) 60 g/L or less Hb 200 ng/ml, transferrin saturation > 20%; 4) The age of 18 (including) - 70) years of age, gender not limited; 5) Weight 45-100 kg; 6) Voluntary subjects, have signed informed consent.

Exclusion criteria

Exclusion criteria: 1) the hemodialysis patients without renal anemia; 2) known or suspected to test drugs and its composition has a history of allergy or intolerance, or allergic constitution; 3) after treatment is still not effectively control severe hypertension (SP 180 or higher/mmHg, DP 110 mmHg or higher); 4) complicating acute infection, acute or combined with chronic infectious disease author or included in the four weeks before checking c-reactive protein (CRP) > 20 mg/L; 5) parathyroid hormone (iPTH) > normal maximum of 9 times; 6) was centrifuged sediment; 7) combined NYHA heart function class for ? - ? congestive heart failure, myocardial infarction; 8) with severe liver disease, or abnormal liver function examination (ALT, AST, upper limit of normal or 2 times, SCr st13 upper limit of normal); 9) with malignant tumor and blood system diseases (myelodysplastic syndrome, hemolytic anemia, etc.) or a variety of causes hemorrhagic and hemolytic disease, neurological and psychiatric disorders to cooperation or not let collaborators; 10) with a lot of bleeding received within three months of surgery patients or clinical trial plan during surgery is (except artificial blood vessels, arteriovenous internal fistula); 11) history, function organ transplantation or stroke due to organ or no kidney transplants, application of immunosuppressant, the splenic function or splenectomy; 12) received within three months of anabolic hormones, heptanoic acid testosterone or beautiful male silane dosage; 13) has a history of blood transfusion within three months; 14) always alcohol and drug abuse; 15) serum albumin < 25% normal lower limit; 16) expected lifetime < 6 months; 17) for nearly three months participated in other clinical trials; 18) during pregnancy, nursing mothers, or a year have fertility planners; 19) researchers think that should not be involved in the other cases of this study.

Design outcomes

Secondary

MeasureTime frame
Reticulocyte Count;Red blood cell specific volume;rhEPO of average weekly dose, injection frequency and total number of injections and total dose comparison;

Primary

MeasureTime frame
Hemoglobin Concentration;

Countries

China

Contacts

Public ContactYao Li
liyao_cmu@163.com+86 13904035673

Outcome results

None listed

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