Topics

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

2018-05-07 14:51:11 | BioPortfolio

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.

Description

Renal transplant recipients using Prograf® as part of their immunosuppressive regimen will be included in the study. Patients will receive oral and written study information and sign the informed consent before entering the study. A 12-hour pharmacokinetic investigation will be performed when Tac doses have been stable for at least 7 days (approximately 3-4 weeks posttransplant). They will continue on unchanged doses of tacrolimus as before PK investigation 1 (PK1). After at least another 7 days a second 12h PK-investigation (PK2) will be performed. If Tac doses needs to be changed after PK1 and before PK2 the second PK will not be performed.

Tac doses and blood concentration obtained as part of standard follow-up of the patients will be included in a non-parametric population model to obtain individually optimal sampling times for each patient using the MMopt function in Pmetrics®. During both PK1 and PK2 the patients themselves will be instructed to take two "home sampling" micro samples (Mitra® microsampling device) just prior to the standard vacutainer samples are obtained. Both the micro- and vacutainer samples will be drawn in 2 parallel samples right after each other and one will be mailed to the laboratory via standard mail. During PK1 the sampling times will be the same and standardized for all patients; before (0h) and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 hours after dose administration. During PK2 individually optimized sampling times based on 2, 3 and 4 samples will be determined using the MMopt function in Pmetrics and utilizing all individual dose and concentration information from before PK2, including the rich sampling during PK1. Spread over the entire study period, at least 6 real life home samplings for trough (C0) of Tac will also be performed by the patient and mailed to the hospital.

Tacrolimus induced tremor will be measured with a center-developed method utilizing infrared determined positioning (sampling ever 5 ms) of hand joints in the x-, y, z axis.

Study Design

Conditions

Renal Transplant Rejection

Intervention

Micro sampling

Location

Oslo University Hospital - Rikshospitalet
Oslo
Norway
0424

Status

Recruiting

Source

Oslo University Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-05-07T14:51:11-0400

Clinical Trials [3341 Associated Clinical Trials listed on BioPortfolio]

A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection

This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant rejecti...

IL2 Imaging in Renal Transplantation

After renal transplantation 5 to 10% of patients experience allograft rejection. Rapid and accurate diagnosis is vital for implementation of additional immunosuppressive therapy. Currently...

Urine CXCL10 Chemokine Monitoring Post-renal Transplant

In this study we will investigate whether early treatment of allograft rejection, as detected by urine CXCL10-monitoring, improves outcomes in renal allograft recipients.

CellCept® Dose Adjustment Versus Fixed Dose (Standard Care) in Renal Transplant Recipients

In order to avoid renal transplant rejection, the immune system should be suppressed. After the renal transplant subjects are treated with a combination of two to four different types of i...

Renal Transporters After Renal Transplantation

Previous studies in animals revealed, that the activity of certain transporters along the nephron is changed with acute rejection after renal transplantation. We intend to investigate unde...

PubMed Articles [6835 Associated PubMed Articles listed on BioPortfolio]

Expression Levels of lncRNAs in the Patients with the Renal Transplant Rejection.

Long non-coding RNAs (lncRNAs) include a vast portion of human transcripts. They exert regulatory roles in immune responses and participate in diverse biological functions. Recent studies indicated dy...

High Dimensional Renal Profiling: Towards a Better Understanding or Renal Transplant Immune Suppression.

The goal of this review is to discuss new approaches to avoid CNI/CCS toxicities with a focus on new biologics and new methods to understand transplant rejection at the single-cell level.

Molecular Analysis of Renal Allograft Biopsies: Where Do We Stand and Where Are We Going?

A renal core biopsy for histological evaluation is the gold standard for diagnosing renal transplant pathology. However, renal biopsy interpretation is subjective and can render insufficient precision...

A Multimodal Computer-Aided Diagnostic System for Precise Identification of Renal Allograft Rejection: Preliminary Results.

Early assessment of renal allograft function post-transplantation is crucial to minimize and control allograft rejection. Biopsy-the gold standard-is used only as a last resort due to its invasiveness...

Tacrolimus variability is associated with de novo donor-specific antibody development in pediatric renal transplant recipients.

Donor-specific antibody (DSA) is a risk factor for antibody-mediated rejection and shortened graft survival. We investigated the role of intrapatient variability in tacrolimus trough levels on graft o...

Medical and Biotech [MESH] Definitions

An immune response with both cellular and humoral components, directed against an allogeneic transplant, whose tissue antigens are not compatible with those of the recipient.

A derivative of sirolimus and an inhibitor of TOR SERINE-THREONINE KINASES. It is used to prevent GRAFT REJECTION in heart and kidney transplant patients by blocking cell proliferation signals. It is also an ANTINEOPLASTIC AGENT.

A sampling methodology using small sample sizes when conducting surveys in small geographical or population-based areas or lots.

Sampling of blood levels of the adrenocorticotropic hormone (ACTH) by withdrawal of blood from the inferior petrosal sinus. The inferior petrosal sinus arises from the cavernous sinus and runs to the internal jugular vein. Sampling of blood at this level is a valuable tool in the differential diagnosis of Cushing disease, Cushing syndrome, and other adrenocortical diseases.

A method for diagnosis of fetal diseases by sampling the cells of the placental chorionic villi for DNA analysis, presence of bacteria, concentration of metabolites, etc. The advantage over amniocentesis is that the procedure can be carried out in the first trimester.

More From BioPortfolio on "Dose Adjustment of Tacrolimus Based on Home Sampling in Renal Transplant Recipients"

Quick Search

Relevant Topics

Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...

Transplantation
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...


Searches Linking to this Trial