Albumin, Total and Free Fraction of Mycophenolic Acid, an... | NCT00995956

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

NCT00995956

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Sep 14, 2012Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Liver Transplant

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Oct 15, 2009

First Submission Date that Met QC Criteria

Oct 15, 2009

First Posted Date

Oct 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2012

Last Update Posted Date

Sep 14, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Liver transplant, MPA treatment

Exclusion Criteria:

malignant disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Liver transplant pations from Rikshospitalet HF

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulf E Kongsgaard, Prof	Oslo University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo university Hospital, Rikshospitalet		Oslo	Oslo	0027	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18269390	Background	Reine PA, Kongsgaard UE, Andersen A, Thogersen AK, Olsen H. Infusion of albumin attenuates changes in serum protein binding of drugs in surgical patients compared with volume replacement with HAES. Acta Anaesthesiol Scand. 2008 Mar;52(3):406-12. doi: 10.1111/j.1399-6576.2007.01555.x.
17038874	Background