Efficacy and safety study of an Epoetin alfa in Thai patients under CAPD.

Phase 4

Recruiting

• Conditions: Renal anemia; renal anemia; anemia in chronic kidney disease

• Registration Number: TCTR20140128002
• Lead Sponsor: Apexcela, Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-28
• Study Completion: 2016-07-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Patients who have consented to participate in the study in writing
2.Patients with chronic renal disease whose GFR is less than 15 ml/min/1.73 m2 and are identified to start peritoneal dialysis
3.Age between 18-70 years on the day of consent
4.Hemoglobin < 9.5 g/dL
5.Serum ferritin level > 100 ng/ml and serum transferrin saturation (TSAT) > 20%

Exclusion Criteria

Main exclusion criteria
1.Patients who have previously used Epoetin
2.Patients who are pregnant or breastfeeding or women of childbearing potential who are not willing to use an effective method of birth control
3.Participation in any drug trial in which the patient received an investigational drug within 3 months prior to screening visit.
4.Patients who have the underlying conditions
-had blood transfusion within 8 weeks prior to screening visit
-Poorly controlled hypertension with diastolic blood pressure greater than 110 mmHg at screening visit.
-History of seizure disorder
-Previous diagnosis with malignant tumor or patients who had residual tumor after anti-cancer therapy elicited by medical history
-Patients with signs and symptoms or laboratory assessment associated with EPO-resistant bone marrow disease such as aplastic anemia, myelodysplastic syndrome, myelofibrosis, myelopthistic anemia or Pure Red Cell Aplasia (PRCA)
-Known hypersensitivity to the mammalian cell-derived product or human albumin products
5.Patients who are using concomitant androgens or immunosuppressive therapy
6. Patients who have Secondary hyperparathyroidism as evaluated by serum parathyroid hormone (PTH) level greater than 800 pg/ml at screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified