Health Condition 1: null- Patients with chronic kidney disease who are on haemodialysis
Conditions
Interventions
Intervention1: Polysialylated Erythropoietin: Polysialylated erythropoietin formulation, which is a performance-enhanced polysialylated form of erythropoietin. It is being developed for the treatment
Sponsors
Serum Institute of India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects willing to give voluntary written informed consent. 2. Males >= 18 and 3. Clinically stable on hemodialysis for >= 3 months before screening (3 sessions per week). 4. Subjects with adequate dialysis ( as determined by Kt/V>=1.2 or URR>=65%) before enrollment. 5. Hemoglobin value of >=8g/dL and 6. Serum ferritin level >= 200 µg/L and transferrin saturation >= 20% within 14 days prior to administration of study drug 7. RBC folate level and Vitamin B12 level above the lower limit of normal within 14 days prior to administration of study drug.
Exclusion criteria
Exclusion criteria: 1. Has received erythropoiesis stimulating agent in the last 6 weeks. 2. Blood transfusions within 4 weeks before screening or during the screening period or anticipated blood transfusion within one month after start of the study. 3. Nonrenal causes of anemia (e.g., Hemoglobinopathy [e.g., homozygous sickle cell disease, thalassemia of all types] , hemolysis, vitamin B12 or folic acid deficiency) 4. History suggestive of pure red cell aplasia (PRCA) 5. C Reactive Protein (CRP) greater than 15 mg/dL within 14 days prior to administration of study drug 6. Secondary hyperparathyroidism as evaluated by serum parathormone (PTH) level greater than 800pg/ml at screening. 7. Poorly controlled hypertension within 4 weeks prior to study drug administration, as per Investigators clinical judgment (e.g. systolic >= 170 mm Hg, diastolic >= 100 mm Hg on repeat readings) 8. Known intolerance to parenteral iron supplementation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Safety (Vital signs, physical examination & ECG, Monitoring of adverse events, Clinical laboratory assessments) of polysialylated erythropoietin administered through IV route.Timepoint: On Day 1, Day 7, Day 14 and Day 28 post dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetic Endpoints Cmax, Tmax, AUC0-t, AUC0-â??, t1/2 and Kel 2. Pharmacodynamic Endpoints â?¢ Absolute & percent Reticulocyte count â?¢ Reticulocyte hemoglobin(CHr) â?¢ Haemoglobin, â?¢ RBC count â?¢ Hematocrit 3. Immunogenicity Endpoints â?¢ Anti-polysialylated erythropoietin antibodies â?¢ Anti-erythropoietin antibodies â?¢ Anti-polysialic acid antibodies.Timepoint: Pharmacokinetics : Pre-dose and 0.25, 1, 2,6,24, 48, 72, 96, 168, 240, 336, 504 and 672 hours post-dose. Pharmacodynamics: Pre-dose and 24, 48, 72, 96, 168, 240, 336, 504 and 672 hours post-dose. Immunogenicity: Pre-dose and on Day 28 post-dose. | — |
Countries
India
Contacts
Public ContactDr Sajjad Desai
Serum Institute of India Pvt. Ltd.
Outcome results
None listed