A Phase II, Randomised, Open label, single subcutaneous dose study of Polysialylated erythropoietin to assess safety, pharmacodynamics and pharmacokinetics in chronic kidney disease patients not on dialysis.

Serum Institute of India LtdPune0 个研究点目标入组 30 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)Patient is informed of the investigational nature of this study and has given written informed consent in accordance with institutional, local, and national guidelines.
•2)Male age greater than or equal to 18 and less than or equal to 70 years of age and Post-menopausal Female age less than or equal to 70 years of age..
•3)Chronic kidney disease stage 3 or 4 (glomerular filtration rate [GFR] of 15-60 mL/min within 14 days prior to administration of study drug,) not requiring dialysis.
•4)Hemoglobin value of less than or equal to 11 g/dL within 14 days prior to administration of study drug.
•5)Serum ferritin level greater than or equal to 100 Âµg/L and transferrin saturation greater than or equal to 20% within 14 days prior to administration of study drug.

•1)Prior treatment with any erythropoiesis stimulating agent .
•2)Overt gastrointestinal bleeding or any other bleeding episode necessitating transfusion within 8 wks before screening or during the screening period .
•3)RBC transfusions within 8 wks before screening or during the screening period .
•4)Nonrenal causes of anemia (e.g., Hemoglobinopathy [e.g., homozygous sickle cell disease, thalassemia of all types], hemolysis, vitamin B12 or folic acid deficiency).
•5)Active malignant disease (except non-melanoma skin cancer).
•6)History suggestive of pure red cell aplasia (PRCA).
•7)C Reactive Protein (CRP) greater than 30 mg/L within 14 days prior to administration of study drug.
•8)Poorly controlled hypertension within 4 wks prior to study drug administration, per Investigators clinical judgment (e.g. systolic greater than or equal to 170 mm Hg, diastolic greater than or equal to 100 mm Hg on repeat readings).

发起方

Serum Institute of India LtdPune