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
- Conditions
- de novo renal transplantation
- Registration Number
- EUCTR2009-011623-31-BE
- Lead Sponsor
- niversity Hospital Ghent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
• 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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method