NCT00139009

Brief Summary

The primary objective is to investigate intralymphocyte concentrations of CsA in renal and heart transplant recipients to elucidate the association between the intracellular concentration and efficacy (rejection episodes and histology) in transplanted patients on CsA based immunosuppressive therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2005

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

June 15, 2007

Status Verified

September 1, 2006

First QC Date

August 29, 2005

Last Update Submit

June 14, 2007

Conditions

Renal TransplantationHeart Transplantation

Keywords

intracellular concentrationcyclosporine Arenal biopsiesheart biopsiesRenal transplant recipients

Outcome Measures

Primary Outcomes (2)

  • rejection

  • pharmacokinetics

Secondary Outcomes (3)

  • toxicity

  • genotypes

  • metabolites

Interventions

Cyclosporine ADRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Renal or heart transplant recipients scheduled to receive CsA as part of their immunosuppressive therapy at the time of transplantation.
  • years of age or older.
  • Signed informed consent.

You may not qualify if:

  • Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepine, fluconazole, ketoconazole, erythromycin, clarithromycin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet, Section of Nephrology

Oslo, Oslo County, 0027, Norway

Location

Related Publications (1)

  • Loftheim H, Midtvedt K, Hartmann A, Reisaeter AV, Falck P, Holdaas H, Jenssen T, Reubsaet L, Asberg A. Urinary proteomic shotgun approach for identification of potential acute rejection biomarkers in renal transplant recipients. Transplant Res. 2012 Aug 31;1(1):9. doi: 10.1186/2047-1440-1-9.

    PMID: 23369437DERIVED

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Anders Åsberg, MSc

    University of Oslo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

June 1, 2005

Study Completion

September 1, 2006

Last Updated

June 15, 2007

Record last verified: 2006-09

Locations

NO(1)