AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01435291
• Date of registration: 15/09/2011
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Nice
• Public title: AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation AADAPT
• Scientific title: Prospective Pharmacokinetic and Pharmacogenetic Analysis of Advagraf After Transplantation
• Date of first enrolment: October 2011
• Target sample size: 45
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01435291
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Elisabeth CASSUTO, PH
• Affiliation: CHU de Nice

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult recipients aged between 18 to 70

- Primary renal transplantation

- Cadaver or living transplantation or living (non HLA identical) donor with compatible
ABO blood type.

- absence of anti-LHA antibodies in lymphocytotoxicity and Luminex

- Negative cross-match in cytotoxicity

- Negative pregnancy test for female patients of childbearing potential, and agreement
to practice effective birth control during the study

Exclusion Criteria:

- Combined transplantation

- Renal bigraft

- History of any other transplantation

- Receiving a graft from a non-heart-beating donor.

- Requiring ongoing dosing with a systemic immunosuppressive drug prior to
transplantation

- Patient who received within one month prior to study an inductor of CYP50 3A or
requiring during the study an inhibitor of CYP50 3A or of P-gp.

- Significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting,
active upper gastro-intestinal tract malabsorption or active peptic ulcer

- Subject or donor known to be HIV positive

- Active viral hepatitis (VHB, VHC) at randomisation

- Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids,
or mycophenolate mofetil or any of the product excipients

- Diagnosis of new-onset malignancy prior to transplantation, with the exception of
basocellular or squamous cell carcinoma of the skin which had been treated
successfully.

- Current participation in any other clinical study

- Any clinical condition which, in the opinion of the investigator, would not allow
safe completion of the study

- Patient not able to comply with the study procedures

- Breast-feeding mother



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Renal Transplantation

Intervention(s)

Drug: Advagraf Capsule

Drug: Prograf Capsule

Primary Outcome(s)

AUC 0-24h of tacrolimus at Day 8 and Day 84 [Time Frame: 3 months]

Secondary Outcome(s)

AUC 24h of tacrolimus using limited samples strategies (LSS) at Day 8 and Day 84 [Time Frame: 3 months]

Secondary ID(s)

11-PP-07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors