de novo renal transplant Classification code 10023438
Conditions
Interventions
Trade Name: myfortic
Product Name: myfortic
Product Code: ERL080A
Pharmaceutical Form: Tablet
INN or Proposed INN: micofenolato de sodio
Concentration unit: mg milligram(s)
Concentration type: up to
C
Sponsors
Novartis Farmaceútica S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female patients between 18 and 70 years of age 2.Male or female patients who are primary cadaveric, living unrelated or non- Human leukocyte antigen (HLA) identical living related donor renal transplant recipients 3.The renal cold ischemic time (CIT) must be =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria at baseline will be excluded from study participation. 1.Patients who have previously received an organ transplant 2.Patients who are recipients of a multiple organ transplants 3.Recipients of non heart-beating donor organs 4.ABO incompatibility against the donor 5.Patients with panel reactive antibodies (PRA) of >20% at most recent assessment prior to transplantation 6.Patients who are known to have a positive hepatitis C serology, who are human immunodeficiency virus (HIV) or Hepatitis B surface antigen positive. Laboratory results obtained within 6 months prior to first dose of myfortic® are acceptable. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded 7.Patients with thrombocytopenia (< 75,000/mm3), with an absolute neutrophil count of <1,500/mm3, and/or leukocytopenia (< 2,500/mm3), or hemoglobin < 6g/dL prior to randomization. 8.Presence of any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures 9.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 10.Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication, and/or presence of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus 11.Patients with clinically significant systemic infection requiring continued therapy 12.Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin 13.Abnormal physical or laboratory findings of clinical significance within 2 weeks prior to first dose of myfortic® which at investigators discretion would interfere with the objectives of the study 14.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin (hCG) laboratory test 15.Women of child-bearing potential (WOCBP), 16. Patients with symptoms of significant somatic or mental illness. Unresolved history of drug or alcohol abuse 17.Inability to cooperate or communicate with the investigator or unable to complete self administered GI symptoms questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superior renal function at 6 months post-transplant in de novo renal transplant recipients who receive myfortic® and reduced tacrolimus levels (Group A) compared to those who receive myfortic® and reference tacrolimus levels (Group B) as measured by calculated glomerular filtration rate (GFR, Nankivell). Patients will also receive Simulect® (basiliximab) and corticosteroids as concomitant immunosuppressant therapy. ;Secondary Objective: The secondary objectives are to compare the efficacy, safety, and tolerability of the combination of myfortic®, Simulect®, and corticosteroids with reduced levels of tacrolimus (Group A) versus reference levels of tacrolimus (Group B). ;Primary end point(s): Primary endpoint is renal function at 6 months measured by calculated glomerular filtration rate (GFR). | — |
Countries
Italy, Spain, United Kingdom
Outcome results
None listed