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A Multicenter Randomized Controlled Trial for Effect of Different rHuEPO Administration Route on Treatment of Anemia and Cardiac Function in Dialysis Patients, MED-route study

A Multicenter Randomized Controlled Trial for Effect of Different rHuEPO Administration Route on Treatment of Anemia and Cardiac Function in Dialysis Patients, MED-route study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022297
Enrollment
Unknown
Registered
2019-04-03
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-05-13

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

Conditions

Chronic Renal Failure

Interventions

IV group:IV EPO
SC group:SC EPO

Sponsors

General Hospital of Ningxia Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: All patients are from the dialysis center of the hospital enrolled in the MED-route study. 1) aged 18 to 70. (Including 18, excluding 70); 2) on regular dialysis for 3 months or over, with stable condition and get the adequate target; 3) for incident patients, 60g/L=Hb<100g/L are requiredfor prevalent patients with or without treatment of EPO, 60g/L=Hb<130g/L are required (the impact of altitude on hemoglobin should be considered); 4) with no plan of changing RRT modality within six months; 5) with good compliance of follow-up; 6) with written informed consent.

Exclusion criteria

Exclusion criteria: 1) suspected for EPO resistance; 2) positive in occult test excluding the causes of oral iron, food ect.; 3) with heart function NYHA class III or IV; 4) with chronic consumptive disease such as tuberculosis, liver cirrhosis, blood system or other malignant tumors; 5) with a diagnosis of systemic or local infection within the latest 4 weeks; 6) primary or complicated with systemic lupus erythematosus, systemic vasculitis and other active autoimmune diseases; 7) allergic to EPO ,intravenous iron or Polyethylene glycol molecule; 8) with uncontrolled severe hypertension ( systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg); 9) with severe hemodynamic abnormalities (such as shock, heart failure); 10) with mental disorders; 11) with severe malnutrition (SGA class C); l2) with a massive hemorrhage (more than 800 ml of hemorrhage) in the latest one month; 13) Pregnant woman or suckling period female or those with pregnancy tests positive. Pregnancy tests could skip if one of the following criteria is satisfied: A. Postmenopausal female (50 years old or over without exogenous hormone replacement therapy at least 12 months). B. younger than 50 years of age without exogenous hormone therapy for at least 12 months and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels at postmenopausal reference range. C. conducted irreversible sterilization surgery, including hysterectomy, bilateral ovariectomy or bilateral salpingectomy, excluding bilateral tubal ligation.

Design outcomes

Primary

MeasureTime frame
Hemoglobin Concentration;Reticulocyte Count;Serum Iron;Ferritin;Transferrin Saturation;Serum Albumin;Cardiac Color Doppler Ultrasound;

Secondary

MeasureTime frame
Mean Corpuscular Volume;intact parathyroid hormone;high sensitive C-reaction protein;Eectrocardiogram;SGA;

Countries

China

Contacts

Public ContactChen Menghua

General Hospital of Ningxia Medical University

nxchenmh@163.com+86 13995083695

Outcome results

None listed

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