Albumin, Total and Free Fraction of Mycophenolic Acid, and Measurement of IMPDH Activity in Liver Transplants. (Albumix)
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|ClinicalTrials.gov Identifier: NCT00995956|
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : September 14, 2012
|Condition or disease|
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|
|Actual Enrollment :||20 participants|
|Official Title:||Quantitative Measurements of Albumin, Total and Free Fraction of Mycophenolic Acid, and Measurement of IMPDH Activity in Liver Transplants.|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995956
|Oslo university Hospital, Rikshospitalet|
|Oslo, Norway, 0027|
|Study Chair:||Ulf E Kongsgaard, Prof||Oslo University Hospital|