Albumin, Total and Free Fraction of Mycophenolic Acid, and Measurement of IMPDH Activity in Liver Transplants. (Albumix)
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Quantitative Measurements of Albumin, Total and Free Fraction of Mycophenolic Acid, and Measurement of IMPDH Activity in Liver Transplants.|
Blood for drug analyzes
|Study Start Date:||January 2010|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995956
|Oslo university Hospital, Rikshospitalet|
|Oslo, Norway, 0027|
|Study Chair:||Ulf E Kongsgaard, Prof||Oslo University Hospital Rikshospitalet|