Fixed Dose MMF vs Concentration Controlled MMF After Renal Transplantation

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center
• Collaborator: Hoffmann-La Roche
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• Renal transplant recipients who have completed their second birthday,

• Recipients from living (related or unrelated), cadaveric (non-heart beating or heart beating) donors,

• Single organ recipient (kidney only),

• Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/ml within 1 week prior to beginning MMF treatment. Effective contraception must be used before beginning therapy, during therapy and for 6 weeks following discontinuation of therapy, even where there has been a history of infertility, unless due to hysterectomy,

• Patients or patient's parent/guardian providing written informed consent,

• Patients co-operative and able to complete all the assessment procedures.

Exclusion Criteria:

• Patients receiving immunosuppressive therapy (except steroid treatment) within the preceding 28 days, except that immunosuppressive medication may be initiated up to 48 hours before transplantation. Furthermore, all patients should receive 1 g [adults] or 600 mg/m2 [paediatric patients] of MMF therapy within 6 hours prior to transplantation,

• PRA > 50% within 6 months prior to enrolment,

• Cold ischaemia time >48 hours,

• History of malignancy (except localised non-melanotic skin cancer) or the presence of any active malignancy at the time of transplant,

• Active peptic ulcer disease,

• Active infection,

• Mandatory intake of prohibited drugs or it is probable that the patient will require treatment with such drugs after transplant,

• Pregnant or lactating females,

• Women of child-bearing potential not willing to use a reliable form of contraception,

• Patient is allergic or intolerant to polysorbate 80 (TWEEN), phenylalanine (aspartame), steroids, MMF, MPA, tacrolimus or cyclosporin,

• Patient or donor with positive tests for HIV or hepatitis B surface antigen,

• Patients with liver cirrhosis or clinical evidence of portal hypertension or other indication of moderate or severe liver disease. (Note: it is strongly recommended that patients with hepatitis C have a liver biopsy performed prior to transplantation),

• Incompatible ABO blood type and/or positive crossmatch,

• Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication with the investigator or with study procedures,

• Patients whose laboratory results reveal severe anaemia (as defined by a haemoglobin value <6 mmol/L [9.7 g/dL] for adults receiving erythropoietin, <4.1 mmol/L [6.6 g/dL] for paediatric patients [regardless of erythropoietin treatment]), leukopenia (as defined by a WBC value of <2500/mm3) or thrombocytopenia (as defined by a platelet count of <75,000/mm3).