Health Condition 1: null- Treatment of anemia associated with chronic kidney disease
Conditions
Interventions
Intervention1: Polysialylated Erythropoietin: Single dose of either 0.5 mcg/kg or 1 mcg/kg or 2 mcg/kg body weight
Control Intervention1: NIL: NIL
Sponsors
Serum Institute of India LtdPune
Eligibility
Inclusion criteria
Inclusion criteria: 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 µg/L and transferrin saturation greater than or equal to 20% within 14 days prior to administration of study drug.
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reticulocyte, Haemoglobin, RBC, HematocritTimepoint: Pre-dose and 24, 48, 72, 96,168, 240, 336, 504 and 672 hours post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity - Estimation of Anti-polysialylated erythropoietin, Anti-erythropoietin, anti-polysialic acid antibodiesTimepoint: Pre-dose and on Day 28 post-dose.;Pharmacokinetics- Estimation of polysialylated erythropoietinTimepoint: Pre-dose and 24, 48, 72, 96, 168., 240, 336, 504 and 672 hours post-dose.;Safety parameters - AEs, Laboratory analysis, Physical examination, Vital signs.Timepoint: On Day 7, Day 14 and Day 28 post dose. | — |
Countries
India
Contacts
Public ContactDr Sajjad Desai
Deputy Medical Director
Outcome results
None listed