Dose Adjustment of Tacrolimus Based on Home Sampling in Renal Transplant Recipients

NCT03512431 | Completed

• 1 other identifier: TacDrop
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Repeated 12-hour pharmacokinetic (PK) investigations in renal transplant recipients for parallel sampling of standard venous bloods samples and finger prick micro samples (Mitra tips). Primary aim to validate the micro sampling tacrolimus concentrations against venous blood concentrations.

Conditions

Renal Transplant Rejection

Keywords

analytical method validation; renal transplantation; limited sampling strategy

Outcome Measures

Primary Outcomes (2)

• Absolute bias of micro sample tacrolimus concentrations

  absolute bias (mico- minus vacutainer sampling) over the clinical range (1 to 40 µg/L) of micro sampled, including simulated "home sampled", Tac trough concentrations

  Within one dose interval of 12 hours

• Relative bias of micro sample tacrolimus concentrations

  Relative bias (mico- minus vacutainer sampling divided by vacutainer sampled) over the clinical range (1 to 40 µg/L) of micro sampled, including simulated "home sampled", Tac trough concentrations

  Within one dose interval of 12 hours

Secondary Outcomes (3)

• popPK Bayesian predicted tacrolimus trough concentration

  Within one dose interval of 12 hours

• PK Bayesian predicted tacrolimus AUC0-12

  Within one dose interval of 12 hours

• Tacrolimus tremor PK/PD relation

  Within one dose interval of 12 hours

Study Arms (1)

Study group

Only one arm in the present study

Diagnostic Test: Micro sampling

Interventions

Micro sampling DIAGNOSTIC_TEST

Compare finger prick micro samples with venous blood samples for measuring whole blood tacrolimus concentrations

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Renal transplant recipients in the first two months after transplantation

You may qualify if:

• Renal transplant recipients
• Females and males
• Patients receiving tacrolimus as part of their immunosuppressive therapy (clinical decision not influenced by this study)

You may not qualify if:

• Patients on concomitant drugs with known pharmacokinetic interaction with tacrolimus

Sponsors & Collaborators

• Oslo University Hospital: lead
• Sandoz: collaborator
• The Norwegian association for renal disease and transplants: collaborator

Study Sites (1)

Oslo University Hospital - Rikshospitalet

Oslo, 0424, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

venous blood samples finger prick micro samples DNA extracted from venous whole blood

Study Officials

• Karsten Midtvedt, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Laboratory

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 30, 2018
• Study Start: April 4, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)