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
- 试验地点
- 15
- 主要终点
- 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.
研究概览
简要总结
This study is a phase III, randomized, open label, two arm, multi-center trial comparing the safety and efficacy of Darbepoetin alfa and Erythropoietin alfa in the treatment of anemia in chronic kidney disease in 236 predialysis and dialysis patients from India. Patients will be randomized in 1:1 ratio between treatment arms and based on previous erythropoietin status (treated or naïve) dose for Darbepoetin alfa and Erythropoietin alfa are administered by subcutaneous injection. The primary outcome will be to assess mean change in hemoglobin between baseline and first evaluation period between the two treatment arms. The secondary outcomes will be to assess the hemoglobin variability, proportion of patients achieving hemoglobin increase ≥1 g/dl from baseline and target of 10-12 g/dl at the end of first evaluation period and time to achieve hemoglobin target range. Pharmacokinetic and immunogenicity will also be evaluated in these patients. The total treatment duration may vary depending on the hemoglobin response and dose titrations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Patients/ Patient’s legally acceptable representative are willing to sign and date written informed consent to participate in the study.
- •In c/o illiterate patients/patient’s LAR, the impartial witness would sign the ICF.
- •â€¢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.
- •â€¢Have adequate Transferrin saturation (≥ 20%) and serum Ferritin (≥100 ng/mL-Predialysis and ≥ 200 ng/mL-Dialysis).
- •â€¢Have expected survival of at least 6 months from time of enrollment (at the discretion of Principal Investigator).
排除标准
- •â€¢Patients on peritoneal dialysis with double lumen catheter within1 month of screening •Hypertension not amenable to standard drugs over 2 weeks of screening period.
- •â€¢Patients treated with Darbepoetin alfa in the past 3 months of screening.
- •â€¢Uncontrolled diabetes mellitus with Hb A1C of 10 or greater.
- •â€¢Congestive Heart Failure of any grade as per New York Heart Association classification.
- •â€¢History of unstable angina or myocardial infarction in last 6 months.
- •â€¢History of Grand mal seizures in last 2 years.
- •â€¢Present with severe hyperparathyroidism (iPTH 1000 pg/mL for Dialysis and iPTH 400 pg/mL for Pre-dialysis).
- •â€¢History of major surgery within 12 weeks of screening.
- •â€¢Systemic hematological diseases including sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma and hemolytic anemia.
- •â€¢Systemic infection, active inflammatory disease and malignancy.
- •â€¢Active liver disease or hepatic enzymes elevated more than 2 times the upper limit of normal.
- •â€¢Pregnant or suspected to be pregnant and breast-feeding women.
- •â€¢Patients scheduled for renal transplant within last 3 months of screening.
- •â€¢Patients who are hypersensitive to any of the active study drug substances and their excipients.
- •â€¢Have occult blood in stool or any other known source of internal bleeding and confirmed gastrointestinal bleeding by endoscopy.
- •â€¢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.
- •â€¢Patients malnourished patients with serum albumin 3.0 gm/dL (on HD and Predialysis) and 2.8 gm/dL (on PD).
- •â€¢Patients who have history of immunosuppressive therapy within 1 month of screening.
- •â€¢Patients having history of previous renal transplantation.
- •â€¢Predialysis- patients who have received dialysis or patients on dialysis and patients who are expected to receive dialysis in next 6 months (as per investigator’s discretion) •Patients who are judged to be ineligible for participation in this study.
结局指标
主要结局
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.
时间窗: First evaluation period-Last 4 weeks of correction phase
次要结局
- Mean change in Hb & its variability in correction phase(Mean Darbepoetin alfa dose during evaluation periods)
研究者
研究点 (15)
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