Albumin, Total and Free Fraction of Mycophenolic Acid, and Measurement of IMPDH Activity in Liver Transplants. (Albumix)

September 13, 2012 updated by: Pål Aarstrand Reine, Oslo University Hospital

Quantitative Measurements of Albumin, Total and Free Fraction of Mycophenolic Acid, and Measurement of IMPDH Activity in Liver Transplants.

In this study we aim to investigate to what extent the serum albumin concentration in liver transplant patients treated with mycophenolic acid (MPA) affect the free fraction of MPA. Furthermore we will investigate if a change in free fraction has implications for the immunosuppressive effect of MPA by measuring the IMPDH activity. This might in the future provide opportunity for further individualisation of the treatment with MPA. We will also investigate if the stabilizers present in pharmaceutical-grade albumin have a displacement effect on MPA in Vitro (ref).

Study Overview

Status

Completed

Conditions

Liver Transplant

Detailed Description

This is a prospective, open, non randomised study without intervention. Our main goal is to find out what effect the albumin concentration has on the free fraction MPA and IMPDH activity in the lymphocytes.

There will be taken blood samples on day 2, 3 or 4 after transplantation. There will be taken one sample before intake of MPA then another 8 samples during the next 4 hours. The samples will be analyzed with regards to MPA and IMPDH. We will follow the progress of free fraction MPA and IMPDH activity (variables; area under the curve, maximum value, minimum value, time to max and min)

The results will be correlated with the other laboratory results and clinical data. In addition to our main aim, to find correlation between free fraction MPA and albumin values, we will describe the relationship between free fraction MPA and IMPDH activity. We will also study the effect on free fraction MPA after adding stabilizers present in pharmaceutical-grade albumin to our serum samples.

The samples will be taken from an indwelling central venous catheter routinely introduced during the transplant surgery. The drug analyses will be performed by the Section for analytic pharmacology and endocrinology. MPA concentrations will be measured by a method based on HPLC with UV-detection. Enzymatic activity for IMPDH will be analysed by a validated method developed in-house (ref). Other biochemical analyzes included in this study is routinely analyzed in liver transplant patients

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Norway
- - Oslo, Norway, 0027
    - Oslo University Hospital, Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Liver transplant pations from Rikshospitalet HF

Description

Inclusion Criteria:

Liver transplant, MPA treatment

Exclusion Criteria:

malignant disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

Study Chair: Ulf E Kongsgaard, Prof, Oslo University Hospital

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

October 15, 2009

First Posted (Estimate)

October 16, 2009

Study Record Updates

Last Update Posted (Estimate)

September 14, 2012

Last Update Submitted That Met QC Criteria

September 13, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

2009/716a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.