An open-label multi-center, multiple dose study to determine the optimum starting dose of intravenous MIRCERA® for maintenance treatment of anemia in pediatric patients with chronic kidney disease on hemodialysis

F. Hoffmann-La Roche Ltd0 个研究点目标入组 41 人开始时间: 2008年6月6日最近更新: 2016年7月4日

适应症

试验速览

暂无简介。

•1. Written informed consent
•2. Pediatric patients 5 -17 years old with clinically stable chronic renal anemia
•3. Hemodialysis treatment for at least 8 weeks
•4. Body weight = 10 kg
•5. Adequate hemodialysis: URR of > 65% or Kt/V >1.2 for patients on thrice weekly HD. Patients with fewer or with more HD sessions per week should have a weekly Kt/V = 3.6
•6. Baseline pre-dialysis Hb concentration 10.0 – 12.0 g/dL determined from the mean of weekly Hb values measured between weeks -2 to -1
•7. Intravenous maintenance epoetin alfa, epoetin beta, or darbepoetin alfa with same dosing interval for at least 8 weeks before screening
•8. Stable maintenance epoetin alfa, epoetin beta, or darbepoetin alfa treatment with no weekly dose change = 25% (increase or decrease) during the 2-weeks of screening. Patients who had been previously treated by the sc route could only
•participate if they have been receiving their ESA by the iv route for at least 8 weeks before screening.
•9. Adequate iron status defined as serum ferritin = 100 ng/mL or TSAT = 20% (or percentage of hypochromic red cells <10%); mean of two values measured during screening
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
•2. RBC transfusions within 8 weeks before screening or during the screening period
•3. Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types)
•4. Hemolysis
•5. Active malignant disease
•6. Chronic, uncontrolled or symptomatic inflammatory disease (e.g. systemic lupus erythematosus)
•7. Poorly controlled hypertension (e.g. BP >95th percentile for age and sex on two consecutive hemodialysis sessions) despite adequate ultrafiltration
•8. Epileptic seizures within 3 months prior to screening and during the screening period
•9. Administration of any investigational drug within 4 weeks prior to screening and planned during the study
•10. Severe hyperparathyroidism (Intact PTH = 1000 pg/ml or whole PTH = 500 pg/ml) or biopsy-proven bone marrow fibrosis
•11. Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol, or to any constituent of the study drug formulation
•12. Pure red cell aplasia (PRCA) or history of PRCA
•13. High likelihood of early withdrawal or interruption of the study (e.g. planned living donor kidney transplant within 16 weeks after randomization)
•14. Planned elective surgery during the entire study period (except hemodialysis access surgery)

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