NCT00995956

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 14, 2012

Status Verified

September 1, 2012

Enrollment Period

8 months

First QC Date

October 15, 2009

Last Update Submit

September 13, 2012

Conditions

Liver Transplant

Keywords

AlbuminMycophenolic acidIMPDHFree fraction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Liver transplant pations from Rikshospitalet HF

You may qualify if:

  • Liver transplant, MPA treatment

You may not qualify if:

  • malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo university Hospital, Rikshospitalet

Oslo, Oslo County, 0027, Norway

Location

Related Publications (2)

  • 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.

    PMID: 18269390BACKGROUND

  • Vethe NT, Bergan S. Determination of inosine monophosphate dehydrogenase activity in human CD4+ cells isolated from whole blood during mycophenolic acid therapy. Ther Drug Monit. 2006 Oct;28(5):608-13. doi: 10.1097/01.ftd.0000245680.38143.ca.

    PMID: 17038874BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for drug analyzes

Study Officials

  • Ulf E Kongsgaard, Prof

    Oslo University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 16, 2009

Study Start

January 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

September 14, 2012

Record last verified: 2012-09

Locations

NO(1)