Computer Guided Doing of Tacrolimus in Renal Transplantation

NCT02010320 | Completed Phase 4

• 1 other identifier: OPTIMAL-13
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Dosing of tacrolimus is challenging due to the large inter-individual variation in its pharmacokinetics. The investigators have developed a pharmacokinetics population model that can be used to estimate individual doses of tacrolimus in renal transplant recipients. The model will be prospective tested in a randomized clinical trial. The hypothesis is that the computer model is superior to experienced transplant physicians in reaching and keeping the patients in the target range of tacrolimus.

Conditions

Renal Transplantation

Keywords

population model; pharmacokinetic; tacrolimus; therapeutic drug monitoring; individualized dosing

Outcome Measures

Primary Outcomes (2)

• Predictive error (Cpred-Cobs)

  Predictive error will be calculated as the computer predicted concentration minus the measured concentration over the first 8 to 12 weeks post-transplant in the computer group. The calculations will be binned into weekly assessments.

  8 to 12 weeks

• Reaching the target concentration

  In each arm the deviation of the observed concentration front he preset target concentration will be calculated for each measured concentration. The deviations will be compared between the two arms.

  8 to 12 weeks post-transplant

Other Outcomes (1)

• Influence of CYP3A5 genotyping

  8 to 12 weeks post-transplant

Study Arms (2)

Computer dosed

EXPERIMENTAL

Patients for which the computer model will calculate the individual doses

Other: Computer dosing

Control

ACTIVE COMPARATOR

Patients which will get their tacrolimus doses determined by experience transplant physicians

Other: Standard dose determination

Interventions

Computer dosing OTHER

Pharmacokinetic population model for individual dose estimations of tacrolimus based on concentrations measurements and inclusion of relevant covariates

Computer dosed

Standard dose determination OTHER

Tacrolimus dose determination according to trough concentrations and standard TDM at the clinic

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• renal transplant recipients using tacrolimus as part of their immunosuppression
• above 18 years
• signed informed consent

You may not qualify if:

• no specific

Sponsors & Collaborators

• University of Oslo School of Pharmacy: lead
• Rikshospitalet University Hospital: collaborator

Study Sites (1)

Olso university hospital - Rikshospitalet

Oslo, 0424, Norway

Location

Related Publications (1)

• Storset E, Asberg A, Skauby M, Neely M, Bergan S, Bremer S, Midtvedt K. Improved Tacrolimus Target Concentration Achievement Using Computerized Dosing in Renal Transplant Recipients--A Prospective, Randomized Study. Transplantation. 2015 Oct;99(10):2158-66. doi: 10.1097/TP.0000000000000708.

  PMID: 25886918 DERIVED

Study Officials

• Anders Åsberg, PhD

  OUS-Rikshospitalet and University of Oslo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: January 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

NO (1)