Health Condition 1: N189- Chronic kidney disease, unspecified Health Condition 2: null- predialysis patients with chronic renal failure(Part B)
Conditions
Interventions
Intervention1: Pegylated Erythropoietin (Zydus): Dosage:-0.6 mcg/kg, 0.9 mcg/kg, 1.2 mcg/kg and optional dose 1.5mcg/kg).
Route:-Subcutaneous.
Frequency:-Once.
Control Intervention1: NA: NA
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint will be the change from the baseline haemoglobin level during the evaluation periodTimepoint: Time point:-42 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in reticulocyte count, over time for 21 days across various treatment groups 2. Pharmacokinetic evaluation a. Peak serum concentration (Cmax) b. Time to reach peak serum concentration (Tmax) c. Area under serum concentration vs. time curve till the last time point (AUC0-t) d. Area under serum concentration vs. time curve extrapolated to the infinity (AUC0- ) e. The residual area in percentage (AUC_% Extrap) f. Serum elimination half-life (t1/2) g. Elimination rate constant ( z)Timepoint: 1. Time point:-Day 21 across various treatment group. 2.predose and 1.00, 2.00, 4.00, 8.00 (optional), 12.00 (optional), 24.00 (optional), 48.00 (optional), 72.00, 144.00 (optional), 216.00 (optional), 288.00, 360.00, 504.00, 672.00, 840.00 and 1008.00 hours following dose of drug administration . | — |
Countries
India
Contacts
Public ContactDr R H Jani
Cadila Healthcare Limited
Outcome results
None listed