EUCTR2007-003955-35-ES进行中（未招募）1 期
Estudio abierto, aleatorizado, controlado y de grupos paralelos para evaluar la eficacia, seguridad y tolerabilidad de MIRCERA por vía subcutánea frente a la ausencia de tratamiento con ESA, en el tratamiento de la anemia en pacientes con nefropatía crónica después del trasplante renal. A controlled open label randomised parallel group study to evaluate the efficacy, safety, and tolerability of subcutaneous MIRCERA, versus no ESA therapy, in the treatment of anaemia in CKD patients after kidney transplant.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 318
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Written informed consent
- •Age 18 years or older
- •Renal transplant =6 months and <5 years prior to randomization (including re-transplant patients)
- •Haemoglobin concentration between 9.5 and 10.5 g/dl at Baseline (mean of the two values obtained at week -4 and -2 during screening period).
- •No ESA therapy during the 3 months prior to randomization
- •Adequate iron status (serum ferritin =100 ng/mL AS WELL AS TSAT =20% OR Hypochromic red cells <10% if serum transferrin or TIBC are unavailable) The mean of the two values obtained during screening period, at week -4 and -2, should be considered.
- •GFR (estimated using the aMDRD equation) between 20 and 60 mL/min during screening period (at week -4 and -2).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Requirement for haemodialysis or peritoneal dialysis therapy within 3 months prior to randomization
- •Change in haemoglobin concentration = 1.5 g/dL during the screening period (week -4 and -2)
- •Change in GFR >30% during the screening period
- •Treatment for clinical acute rejection during screening period with GFR stability below 30%
- •Recipients of other solid organs in addition to kidneys
- •Patients planned to be switched from one immunosuppressive agent to another during study participation
- •History of positive Anti-phospholipid antibodies
- •Transfusion of red blood cells during the 3 months prior to randomization
- •Poorly controlled hypertension as judged by the investigator, OR requiring more than 3 antihypertensive drugs (excluding diuretics)
- •Significant acute or chronic bleeding, such as overt gastrointestinal bleeding, i.e. requiring therapy within 3 months prior to randomization
- •Active malignant disease (except non-melanoma skin cancer).
- •Haemolysis
- •Haemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
- •Folic acid deficiency
- •Vitamin B12 deficiency
- •Platelet count >500 x 10 exp9/L or <100 x 10 exp9/L
- •Pure red cell aplasia
- •Epileptic seizure in the 6 months prior to randomization
- •Congestive heart failure (NYHA Class IV)
- •Myelofibrosis
- •Active systemic lupus erythematosus
- •Myocardial infarction or stroke, severe or unstable coronary artery disease, severe liver disease during the 3 months prior to randomization
- •Uncontrolled or symptomatic secondary hyperparathyroidism
- •Women with positive pregnancy tests prior to randomization
- •Women of childbearing potential without effective contraception or women in lactation period
- •Women of childbearing potential without effective contraception
- •Participation in a clinical trial or receipt of investigational compound or treatment within the 3 months prior to randomization
- •Planned elective surgery during the study period Exceptions are:
- •Cataract surgery
- •Vascular access surgery
- •Urethral stent removal
- •Nephrostomy tube replacement
- •Minor surgery not requiring hospitalisation
- •Known HIV infection
- •Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
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