A Prospective Study to Investigate Mycophenolic Acid (MPA) Exposure Through Area Under the Curve (AUC) in Renal Transplants Recipients Treated With Mycophenolate Mofetil (MMF) and After Conversion to Mycophenolate Sodium (EC-MPS)

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is investigate mycophenolic acid exposure through area under the curve in renal transplants recipients treated with mycophenolate mofetil and after conversion to mycophenolate sodium.

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

Details

• Lead Sponsor: Irmandade Santa Casa de Misericórdia de Porto Alegre
• Collaborator: Novartis
• Treatments: Calcineurin Inhibitors; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• Age ≥ 18 years at the time of screening;

• Subjects above the sixth month post renal transplant;

• Subjects receiving mycophenolate mofetil;

• Women of childbearing potential (CBP) with a negative pregnancy test at screening (urine or serum);

• Women of CBP and men with sexual partners of CBP must agree to use a medically acceptable method of contraception throughout the study.

Exclusion Criteria:

• Subjects who, in the opinion of the investigator, are not able to complete the study;

• Recipients of multiple organ transplant (i.e., prior or concurrent transplantation of a non-renal allograft;

• Use of any investigational drug or treatment up to 4 weeks before enrollment;

• Subjects with a calculated GFR < 30ml/min (abbreviated MDRD formula);

• Subjects with a screening total white blood cell count (WBC) ≤ 2000/mm3, hemoglobin ≤ 10g/dL and platelet count ≤ 100000/mm3;

• TGO/AST, TGP/ALT and bilirubin with values three times higher that reference values;

• History of malignancy within 3 years enrollment other than adequately treated basal cell or squamous cell carcinoma of the skin;

• Subjects who are known to be human immunodeficiency virus (HIV), hepatitis B or hepatitis C;

• Chronic hepatic failure;

• Planned treatment with immunosuppressive therapies other than those described in the protocol;

• Recipients who required desensitization protocols.