A randomized, controlled, open-label, multi-centre, parallel-group study to assess all-cause mortality and cardiovascular morbidity in patients with chronic kidney disease on dialysis and those not on renal replacement therapy under treatment with MIRCERA® or reference ESAs. - Post Authorization Safety Study (PASS)

F.Hoffmann-La Roche Ltd0 个研究点目标入组 2,800 人开始时间: 2008年10月21日最近更新: 2017年9月4日

试验速览

暂无简介。

•1. Written informed consent
•2. Adult patients (=18 years old) with symptomatic anaemia associated with CKD (renal anaemia)
•3. Patients with renal anaemia who are not treated with an ESA:
•– Anaemia defined as Hb concentration < 11.0 g/dL (mean of 2 screening values with at least one day between measurements)
•3. Patients with renal anaemia who are on maintenance ESA therapy:
•– If on dialysis: regular long-term or peritoneal dialysis therapy with the same mode of dialysis for at least 3 months before screening
•– Continuous iv or sc maintenance ESA therapy: darbepoetin alfa (Aranesp®, Nespo®, Aranest®), epoetin alfa (Eprex®, Epogen®, Epopen®, Erypo®) or epoetin beta (NeoRecormon®, Recormon®) administered according to approved label of the same agent and route of administration for at least 2 months before screening
•– Hb concentration between 10 and 12 g/dL (mean of 2 screening values with at least one day between measurements)
•4. Patients with adequate iron status defined as: serum ferritin above or equal to 100 µg/l or transferrin saturation above or equal to 20% (See section 4.4 of the SmPC).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1680
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1120

•Contraindications to ESA treatment (See Section 4.3 of SmPC):
•1. Uncontrolled hypertension
•2. Hypersensitivity to the active substance or any of the excipients of MIRCERA® and other ESAs
•3. Any other contraindication to ESA therapy
•Conditions known to cause inadequate response to ESA treatment or anaemia other than symptomatic anaemia associated with CKD, including (See Section 4.4. of the SmPC):
•4. Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types)
•5. Anaemia due to hemolysis
•6. Pure red cell aplasia (PRCA)
•7. High likelihood of early withdrawal (e.g. within 1 year) or interruption of the study
•8. Pregnancy or breast-feeding
•9. Women of childbearing potential without effective contraception
•10. Administration of another investigational drug within 1 month before screening or planned during the study period

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