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Recombinant human erythropoietin injection (CHO cells) in the treatment of persistent peritoneal dialysis renal anemia: a randomized, positive parallel control, open multicenter clinical trial

A randomized, positive parallel control, open multicenter clinical trial of recombinant human erythrotropin injection (CHO cell)(Ji Mai Xin ) in the treatment of persistent peritoneal dialysis renal anemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034705
Enrollment
Unknown
Registered
2020-07-15
Start date
2020-08-31
Completion date
Unknown
Last updated
2020-07-20

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

Conditions

renal anemia

Interventions

experimental group:12000 IU/ piece, hypodermic injection
control group:10000 IU/ piece, hypodermic injection

Sponsors

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 90 = 10.0g/dL and = 1.7) in the past 6 months, have no plan to change the approach of renal replacement therapy for nearly half a year.

Exclusion criteria

Exclusion criteria: 1) Patients with uncontrolled severe hypertension (SP >= 180mmHg, DP >=110mmhg); 2) Severe malnutrition grade C assessed by SGA; 3) Patients who had any clinically diagnosed severe systemic or local infection or evidence of active potential infection 4 weeks before selection, such as blood hsCRP > 15mg/L before selection; 4) Patients with congestive heart failure [New York Heart Association grade III or above]; 5) Those with AST or ALT value 3 times the upper limit of > standard value and Alb< 2.5g /dL in 4 weeks before selection; 6) Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (anti-HCV Ab), positive for tuberculin test; 7) Patients with past history of stroke, who are on immunosuppressive drugs/primary or associated with autoimmune diseases such as systemic lupus erythematosus, systemic vasculitis and are in the active stage, or associated with other severe wasting, systemic disease cirrhosis, malignant tumors; 8) Patients with malignant tumors (including hematologic malignancies), hematologic diseases (myelodysplastic syndrome, hemolytic anemia, hypersplenism, etc.) or obvious hemorrhagic diseases; 9) Patients who had received surgical operations with massive bleeding in the previous 3 months or who planned to receive surgical operations during the clinical trial (except for arteriovenous shunt); 10) Patients with chronic blood loss (those with positive occult blood test 4 weeks before inclusion) and those who need to complete elective surgery leading to significant blood loss during the test; 11) Previous functional organ transplant or scheduled organ transplant or no kidney; 12) Severe hemodynamic abnormalities (e.g. shock); 13) Those who received anabolic protein hormone, testosterone heptanate or meandrosterone within 3 months; 14) A past alcohol and drug abuser; 15) Unable to cooperate or unwilling to cooperate due to the combination of neurological and mental disorders; 16) Those who are known to be allergic to the known ingredients of test or control drugs and intravenous iron agents; 17) Those who are pregnant, breastfeeding, or have recently had a family planning or of childbearing age; 18) Blood transfusion history within 3 months; 19) Those who have participated in other clinical trials in recent 3 months; 20) The investigator considers that he/she has any other medical conditions unsuitable to participate in the study.

Design outcomes

Primary

MeasureTime frame
Blood routine;

Countries

China

Contacts

Public ContactYang Hongtao

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

tjtcmpeiming@126.com+86 022-27986563

Outcome results

None listed

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