de novo renal transplantation
Conditions
Interventions
Trade Name: Cellcept
Product Name: Mycophenolate Mofetil
Pharmaceutical Form: Tablet
INN or Proposed INN: MYCOPHENOLATE MOFETIL
CAS Number: 115007346
Concentration unit: mg milligram(s)
Concentration
Sponsors
University Hospital Ghent
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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 =2.5mg/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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate difference in • measured glomerular filtration rate (mGFR) and estimated glomerular filtration (eGFR) between study groups • chronic alloimmune injury/rejection and nonimmune injury according to BANFF 2005 • terms of cardiovascular risk scores,and New Onset Diabetes After Transplantation(NODAT) • terms of cardiovascular mortality • To evaluate safety in terms a) of acute rejection rate b) of infection rate and cancer For the extension study - to investigate whether • intravenous Mg supplementation in patients with profound hypomagnesemia (<1.7mg/dl) in the immediate post-transplantation period results in a) higher serum Mg levels; b)improvement of insulin resistance and c)less NODAT post transplantation (defined by the ADA-criteria). • Peroral Mg supplementation in patients with hypomagnesemia over a 3 month course might beneficially impact on insulin resistance measured by validated parameters.;Secondary Objective: For the extension study: To check whether there is a cross-sectional relation between insulin resistance and posttransplantation hypomagnesemia;Primary end point(s): • Difference in measured glomerular filtration rate (mGFR) and estimated glomerular filtration (eGFR) between study groups • Difference in chronic alloimmune injury/rejection and nonimmune injury according to BANFF 2005 • Difference in terms of cardiovascular risk scores,and New Onset Diabetes After Transplantation(NODAT) • Difference in terms of cardiovascular mortality • Safety in terms of acute rejection rate • Safety in terms of infection rate and cancer For the extension study: • higher serum Mg levels; • improvement of insulin resistance and • less NODAT the first year post transplantation | — |
Countries
Belgium
Outcome results
None listed