Health Condition 1: N189- Chronic kidney disease, unspecified Health Condition 2: null- Maintaining hemoglobin level in chronic renal failure
Conditions
Interventions
Intervention1: Epoetin: 50 I.U./kg i.v. or s.c.
Intervention2: Folic acid: 1mg/day (Concomitant therapy)
Intervention3: Vitamin B Complex: Oral (Concomitant therapy)
Intervention4: Iron: 200mg Oral o
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Medically stable CRF patients of either gender with age ≥ 18 years. 2.History of EPO alpha therapy for at least 6 weeks at the time of enrolment. 3.Haemoglobin level more than or equal to 9 g/dL. 4.Given written informed consent for participating in the trial.
Exclusion criteria
Exclusion criteria: 1.Pregnancy or nursing mothers. 2.History of adverse drug reaction related with EPO alpha treatment. 3.History of uncontrolled hypertension (Diastolic blood pressure more than or equal to 110 mmHg and/or Systolic blood pressure; more than or equal to 180 mm Hg) despite at least one anti-hypertensive therapy during past three weeks. 4.Clinically unstable patients in the judgement of the investigator [immediate post-myocardial infarction, severe congestive heart failure (NYHA Class IV), unstable coronary artery disease] 5. History of epilepsy or seizures. 6. History of hypersensitivity to mammalian cell derived protein or any of the components of this product and human albumin. 7. History of malignancies. 8. History of anaemia due to other causes like acute or chronic blood loss, infections in last six weeks, iron deficiency anaemia (TSAT < 16%), Vitamin B12 or folic acid deficiency anaemia, untreated menorrhagia, hypothyroidism etc. 9. History of haemoglobinopathies. 10. Thrombocytopenia (platelet count <100,000/UL) or leukopenia (WBC < 2000/UL). 11. History of any other serious concurrent illness like systemic lupus erythematosus, Porphyria etc. 12. History of complications related with dialysis such as Osteitis fibrosa cystica, aluminum toxicity etc. 13. History of blood transfusion in past six weeks. 14. History of major surgery in last 12 weeks or planned surgery in next 6 weeks. 15. History of severe hepatic dysfunction. 16. Participation in any other trial in the past 3 months or concommitant participation in any other trial. 17. Not willing to give informed consent. 18. Patient, who according to the attending physician, is not able to understand and follow the instructions for follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hemoglobin level from baselineTimepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in hematocrit levels from baselineTimepoint: upto 6 weeks | — |
Countries
India
Contacts
Public ContactDr R H Jani
Cadila Healthcare Ltd.
Outcome results
None listed