Calcineurin Activity in Renal Recipients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01413685
• Date of registration: 24/06/2011
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Calcineurin Activity in Renal Recipients
• Scientific title: Interest of Calcineurin Activity for the Therapeutic Tacrolimus Monitoring in Renal Recipients
• Date of first enrolment: January 2009
• Target sample size: 23
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01413685
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Philippe GRIMBERT
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

Inclusion Criteria:

- adult renal transplant recipients

- treated by tacrolimus (Prograf or ADVAGRAF), corticoids, Cellcept,

Exclusion Criteria:

- patients with a high risk of bad compliance (toxicomania, severe psychiatric
troubles)

- multiorgan transplant patients with mTOR inhibitors treatments

- HIV infected patients

- lack of consent for this study



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Renal Transplant Rejection

Intervention(s)

Other: Pharmacokinetics/dynamics

Primary Outcome(s)

Determination of tacrolimus concentrations in whole blood and of calcineurin activities in lymphocytes [Time Frame: at day 8, day15, day21 (pharmacokinetics on 4 times samples), day 28, month 2 and month 3 (residual measurement)]

Secondary Outcome(s)

Pharmacogenetics (3A5) [Time Frame: at day 8, day 15, day 21, day 28, month 2 and month 3]

Secondary ID(s)

P071004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors