SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT01413685

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Interest of Calcineurin Activity for the Therapeutic Tacrolimus Monitoring in Renal Recipients

The purpose is to define if calcineurin activity is a better biological parameter than blood concentration for the therapeutic tacrolimus monitoring.

NCT01413685 Renal Transplant Rejection

1 Interventions

Name: Pharmacokinetics/dynamics

Description: Determination of tacrolimus concentrations in whole blood and of calcineurin activities in lymphocytes at D8, D15, D21 (pharmacokinetics on 4 times samples), D28, M2 and M3 (residual measurement)

Type: Other

Tacrolimus


Primary Outcomes

Measure: Determination of tacrolimus concentrations in whole blood and of calcineurin activities in lymphocytes

Time: at day 8, day15, day21 (pharmacokinetics on 4 times samples), day 28, month 2 and month 3 (residual measurement)

Secondary Outcomes

Description: Genotyping of CYP3A5 * 3 (A6986G) and mdr-1: mutations of these proteins could explain the changes of absorption of tacrolimus. For each patient, during the first month of treatment, 5 ml of blood will be collected on EDTA tube. Genotyping is realized by the allelic discrimination technique Taqman, on a ABI Prism 7000 (TaqMan ®) in the Molecular Biology unit, Pharmacogenetics and Hormonology Bicêtre Hospital

Measure: Pharmacogenetics (3A5)

Time: at day 8, day 15, day 21, day 28, month 2 and month 3

Purpose: Diagnostic

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 A6986G

Genotyping of CYP3A5 * 3 (A6986G) and mdr-1: mutations of these proteins could explain the changes of absorption of tacrolimus. --- A6986G ---



HPO Nodes