A clinical trial to study the effects of epoetin in patients with chronic renal failure
- Conditions
- Health Condition 1: N189- Chronic kidney disease, unspecifiedHealth Condition 2: null- Maintaining hemoglobin level in chronic renal failure
- Registration Number
- CTRI/2008/091/000257
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in hemoglobin level from baselineTimepoint: 6 weeks
- Secondary Outcome Measures
Name Time Method Change in hematocrit levels from baselineTimepoint: upto 6 weeks