Status:
COMPLETED
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)
Lead Sponsor:
Irmandade Santa Casa de Misericórdia de Porto Alegre
Collaborating Sponsors:
Novartis
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 mycophenolat...
Detailed Description
A growing body of evidence has shown that mycophenolate acid (MPA) exposure assessment and dosage adjustment are necessary in patients treated with mycophenolate mofetil (MMF), but there is still limi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01822483
Start Date
April 1 2013
End Date
March 1 2015
Last Update
April 3 2015
Active Locations (1)
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1
Irmandade Da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90020090