EUCTR2009-011623-31-BE进行中（未招募）1 期
Individually adapted immunosuppression in de novo renal transplantation based on immune function monitoring: a prospective randomised studyExtension study: The impact of magnesium supplementation on posttransplantation insulin resistance in renal transplant recipients: a prospective randomized open label study
niversity Hospital Ghent0 个研究点开始时间: 2009年4月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
入选标准
- •First or second kidney transplantation
- •Males and females, 18 years old or older
- •Women of childbearing potential must have a negative serum or urine pregnancy test with sensitivity equal to at least 50 mIU/ml.
- •Patients must be capable of understanding the purpose and risks of the study and must sign an informed consent form
- •For the extension study:
- •Single renal transplant recipients, aged >18y
- •Triple immunosuppression consisting of corticosteroids (with perioperative bolus of 500mg methylprednisolone, 125mg IV methylprednisolone on day 1 followed by 12mg peroral methylprednisolone from day 2 until the end of the first month with further gradual tapering according to stratified schema), mofetil mycophenolate (Cellcept ®)/mycophenolate acid (Myfortic®) and tacrolimus (Prograft®). Induction with basiliximab (Simulect®).
- •Hypomagnesemia <1.7mg/dl on 2 consecutive blood samples (laboratory normal value between 1.7-2.55mg/dl in our lab)
- •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
- •Multiple organ transplantation (eg. kidney-pancreas, kidney-heart, kidney-liver,…)
- •Transplantation of a patient who recieved another organ transplant previously except one kidney transplantRecipients of HLA-identical living-related renal transplants
- •Patients with PRA > 10%, patients who have lost a first graft from rejection.
- •Pregnant or lactating women
- •WBC =< 2.5 x 109/L (IU), platelet count =< 100 x 109/L (IU), or Hb =< 6 g/dl at the time of entry into the study
- •Active peptic ulcer
- •Severe diarrhea or other gastrointestinal disorders which might interfere with the ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy
- •Known HIV-1 or HTLV-1 positive tests
- •History of malignancy in the past 5 years (with the exception of adequately treated basal or squamous skin cell carcinoma
- •The use of investigational drugs or other immunosuppressive drugs as those specified in this protocol
- •Patients receiving bile acid sequestrants
- •Psychological illness or condition interfering with the patient’s compliance or ability to understand the requirements of the study.
- •For the extension study:
- •additive to exclusion criteria CD4-trial:
- •Pre-existing diabetes mellitus according to American Diabetes Association (ADA)-criteria
- •Biopsy proven acute rejection and consecutive treatment with corticosteroid bolusses
- •Patients already on magnesium supplementation before inclusion.
- •Serum creatinine>2.5mg/dl
- •Active infection (CRP>3mg/dl)
- •Severe hypomagnesemia (<1.2mg/dl)
- •Hypokalemia (<3.5meq/l)
- •Severe hypocalcemia (<7mg/dl)
- •Intake of digoxin
- •QTc elongation on ECG 12 lead measurement (in excess of 0.44 sec)
- •Systolic blood pressure <110mmHg
- •Patients will be excluded from the study if the daily measurements after previous inclusion show Mg values to be less than 1.2mg/dl, if potassium levels are lower than 3.5meq/l or calcium levels lower than 7mg/dl.
- •They will also be excluded if during the course of the study corticosteroid bolusses are needed because of BPAR
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