Health Condition 1: null- Patients for correction of anemia due to Chronic Kidney Disease
Conditions
Interventions
Intervention1: R-TPR-026: Dose:0.75 mcg/kg,
Frequency: Once every 2 weeks during 24 weeks,
Mode of administration: Subcutaneous
Control Intervention1: Aranesp®: Dose:0.75 mcg/kg,
Frequency: Once e
Sponsors
Reliance Life sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Diagnosed with anemia due to Chronic Kidney Disease (CKD) 2 On hemodialysis or peritoneal dialysis prior to enrollment in the study 3 ESA therapy naive or ESA therapy-free for at least 3 months 4 Hb 5 TSAT >= 20% 6 Females of childbearing potential should be willing to use an approved method of double-barrier contraception and should have a negative pregnancy test. 7 Able to understand the study procedures, the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
Exclusion criteria
Exclusion criteria: 1. Current severe, uncontrolled systemic disease (e.g., clinically significant hematological disease such as sickle cell anemia, myelodysplasia, hematological malignancy, hemolytic anemia, inflammatory, infectious, psychiatric or other conditions interfering with erythropoietic response) 2. RBC transfusion to treat anemia within 8 weeks before enrollment or scheduled to receive RBC transfusion 3. New York Heart Association class III or IV Congestive Heart Failure 4. Uncontrolled hypertension (Diastolic BP 110 mmHg or systolic BP 180 mmHg) during screening 5. Major surgical procedure in last 12 weeks before enrollment or anticipation of the need for major surgery during the course of study treatment 6. Androgen therapy within 12 weeks prior to start of study 7. Scheduled to receive a renal transplant 8. Cardiovascular disease (Acute myocardial infarction or hospitalization for CHF within 12 weeks before enrollment) 9. Evidence of conditions like deep vein thrombosis, cerebrovascular event (stroke or transient ischemic attack) within 12 weeks before enrollment 10. Uncontrolled hyper parathyroidism 1500 pg/ml during last 12 months 11. Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia 12. History of intolerance or hypersensitivity to darbepoetin alfa 13. Pregnant or breast-feeding women 14. Women of child bearing potential who are not using effective contraception during participation in the study and do not agree to do so for at least 28 days after final dose of investigational product. 15. Subjects with HIV, HBsAg, HCV test positive. 16. Participation in any study within 30 days before enrollment or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study 17. Any other condition which investigator feels would pose a significant hazard to subject if IP is administered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy will be assessed by Hemoglobin responder rate i.e., proportion of patients achieving 1 g/dL rise in Hb from baseline at Week 8Timepoint: week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients maintaining mean Hb within target range (9-12 g/dL) at Week 24Timepoint: week 24;Average dose of R-TPR-026/Aranesp® administered for achievement of rise of hemoglobin in the target range (9-12 g/dL) at Week 24Timepoint: week 24;Proportion of patients achieving rise in hemoglobin i.e., 1 g/dL rise from baseline, at Week 24Timepoint: week 24;Evaluation of safetyTimepoint: week 24;Mean change in Hb level between the screening/baseline period and end of the studyTimepoint: week 24;Pharmacodynamic parameter o Reticulocyte count assessed at Day 2 and Day 4 of Week 0, every week from Week 1 to Week 8, every alternate week from Week 10 to Week 20 and every week from Week 21 to Week 24 Timepoint: week 24;Pharmacokinetic parameters (Cmax and AUC0-168) will be calculated for single dose of R-TPR-026 and Aranesp®Timepoint: week 24 | — |
Countries
India
Contacts
Public ContactDr Prashant Pandya
Reliance Life Sciences Pvt.Ltd
Outcome results
None listed