Health Condition 1: null- Anemia associated with Chronic Kidney Disease (CKD) Health Condition 2: D631- Anemia in chronic kidney disease
Conditions
Interventions
Intervention1: Darbepoetin alfa: 0.45 mcg/kg, subcutaneous injection for not more than 36 weeks.
Control Intervention1: Erythropoietin alfa: 50 IU/kg, subcutaneous injection for not more than 36 weeks
Sponsors
Hetero Drugs Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Patients/ Patientâ??s legally acceptable representative are willing to sign and date written informed consent to participate in the study. In c/o illiterate patients/patientâ??s LAR, the impartial witness would sign the ICF. • Are of either sex aged 18 to 65 years (both inclusive) • Predialysis stage of CKD (Stage 3 and 4 with GFR between 15-59 mL/min/1.73 m2 • Dialysis patients- Hemodialysis (with AV fistula) or peritoneal dialysis for last 4 weeks and have baseline Hb • Clinically stable patients, who are erythropoietin-naïve or patients treated with erythropoietin but not within one week prior to screening. • Have adequate Transferrin saturation (>= 20%) and serum Ferritin (>=100 ng/mL-Predialysis and >= 200 ng/mL-Dialysis). • Have expected survival of at least 6 months from time of enrollment (at the discretion of Principal Investigator).
Exclusion criteria
Exclusion criteria: • Patients on peritoneal dialysis with double lumen catheter within1 month of screening • Hypertension not amenable to standard drugs over 2 weeks of screening period. • Patients treated with Darbepoetin alfa in the past 3 months of screening. • Uncontrolled diabetes mellitus with Hb A1C of 10 or greater. • Congestive Heart Failure of any grade as per New York Heart Association classification. • History of unstable angina or myocardial infarction in last 6 months. • History of Grand mal seizures in last 2 years. • Present with severe hyperparathyroidism (iPTH 1000 pg/mL for Dialysis and iPTH 400 pg/mL for Pre-dialysis). • History of major surgery within 12 weeks of screening. • Systemic hematological diseases including sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma and hemolytic anemia. • Systemic infection, active inflammatory disease and malignancy. • Active liver disease or hepatic enzymes elevated more than 2 times the upper limit of normal. • Are treated with androgen therapy within 8 weeks of screening. • Pregnant or suspected to be pregnant and breast-feeding women. • Patients scheduled for renal transplant within last 3 months of screening. • Patients who are hypersensitive to any of the active study drug substances and their excipients. • Have occult blood in stool or any other known source of internal bleeding and confirmed gastrointestinal bleeding by endoscopy. • Patients with seropositivity to Human Immunodeficiency Virus, Hepatitis B and/or Hepatitis C infection (in c/o liver enzymes-AST and ALT raised 2-times of laboratory normal values) • Patients having active tuberculosis or any other active infection for previous one month. • Patients malnourished patients with serum albumin 3.0 gm/dL (on HD and Predialysis) and 2.8 gm/dL (on PD). • Patients undergoing blood transfusions within 2 weeks prior to screening. • Patients who have history of immunosuppressive therapy within 1 month of screening. • Patients having history of previous renal transplantation. • Patients having participated in any other clinical trial within one month prior to screening. • Predialysis- patients who have received dialysis or patients on dialysis and patients who are expected to receive dialysis in next 6 months (as per investigatorâ??s discretion) • Patients who are judged to be ineligible for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Hemoglobin between baseline and First evaluation period with minimum 12 weeks of treatment for correction of anemia in both predialysis and dialysis patients.Timepoint: First evaluation period-Last 4 weeks of correction phase | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Hb & its variability in correction phase Mean Darbepoetin alfa dose during evaluation periods Evaluate the pharmacokinetics and immunogenicity Proportion of patients achieving the Hb target defined as Hb increase of â?¥1 gm/dL from baseline and Hb concentration of 10-12 gm/dL at the end of First evaluation period. Time to initial achievement of Hb target as specified in the protocol. Treatment emergent adverse events Timepoint: Baseline to Week 4 Correction phase not more than 24 weeks Evaluation periods: Last 4 weeks of correction and maintenance phase | — |
Countries
India
Contacts
Public ContactDr Rudolph Julius D Almeida
Hetero Group
Outcome results
None listed