NCT01413685

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
Last Updated

November 14, 2014

Status Verified

November 1, 2014

Enrollment Period

1.5 years

First QC Date

June 24, 2011

Last Update Submit

November 13, 2014

Conditions

Renal Transplant Rejection

Keywords

tacrolimuscalcineurinpharmacodynamicTDMpharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Determination of tacrolimus concentrations in whole blood and of calcineurin activities in lymphocytes

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

Secondary Outcomes (1)

  • Pharmacogenetics (3A5)

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

Study Arms (1)

Tacrolimus

NO INTERVENTION

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)

Other: Pharmacokinetics/dynamics

Interventions

Pharmacokinetics/dynamicsOTHER

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)

Tacrolimus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult renal transplant recipients
  • treated by tacrolimus (Prograf or ADVAGRAF), corticoids, Cellcept,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Henri Mondor

Créteil, 94000, France

Location

MeSH Terms

Interventions

Pharmacokinetics

Intervention Hierarchy (Ancestors)

MetabolismPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Officials

  • Philippe GRIMBERT

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2011

First Posted

August 10, 2011

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

November 14, 2014

Record last verified: 2014-11

Locations

FR(1)