CTRI/2012/07/002835已完成3 期
A randomized, open label, multi-center study to evaluate the efficacy, tolerability and safety of Darbepoetin alfa as compared to Erythropoietin in anemia associated with chronic kidney disease (CKD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 236
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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).
排除标准
- •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.
研究者
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