A clinical trial to study the effects of Darbepoetin alfa in the treatment of anemia caused by chronic kidney disease.
- Conditions
- Health Condition 1: null- Anemia associated with Chronic Kidney Disease (CKD)Health Condition 2: D631- Anemia in chronic kidney disease
- Registration Number
- CTRI/2012/07/002835
- Lead Sponsor
- Hetero Drugs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 236
•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 <12 gm/dL. using MDRD equation) and Mean baseline Hb 7-10 gm/dL (both inclusive). Patients below 7 gm/dl will not include in the study
•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).
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method