â??A multicentre, prospective, study to evaluate the safety and efficacy of PEGEPO(Pegylated Erythropoietin) in healthy volunteers and patients with chronic renalfailure.â??

Cadila Healthcare Limited0 个研究点目标入组 36 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male or female patients diagnosed with chronic renal failure (GFR 15-60 mL/min/1.73
•m2), aged 18 to 65 years (including both).
•2. Pre-dialysis patients (Part B) and patients receiving regular haemodialysis two to three
•times per week for at least 8 weeks (Part C).
•3. Patients having haemoglobin level 6.5-10 gm/dL at screening visit.
•4. Patients with at least 20% of TSAT and >=200 ng/mL of ferritin at screening.
•5. Subject has given informed consent for participation in this trial

•1.Pregnancy and lactation.
•2. Patients with uncontrolled hypertension (patients with over 100 mm Hg of diastolic
•blood pressure)
•3. Acute Renal Failure
•4. Evidence of Vitamin B12 or folic acid deficiency anaemia,
•5. Subjects having any other known cause of anaemia.
•6. Patients with congestive heart failure (CHF) of grade III or higher (as per New York
•Heart Association Class III)
•7. Patients with malignancy (including hematologic malignancy), systemic blood disorder
•(myelodysplastic syndrome, pure red cell aplasia, haemolytic anaemia etc.)
•8. Patients who have known human immunodeficiency virus (HIV) infection
•9. Patients who have received an administration of anabolic hormone/ Conventional
•erythropoietin within last 7-10 days.
•10. Patients who had received administration of another study drug within 12 weeks.
•11. Patients who have previously received an administration of darbepoetin or MIRCERA
•12. Patients who are confirmed to have a serious allergy or serious drug allergy
•13. Patients who are hypersensitive to r-HuEPO or Pegylated products
•14. Patients whose aspartate transaminase (AST) or alanine transaminase (ALT) is 2 times
•the institutional upper normal limit.

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