NCT00275639

Brief Summary

This research study is being done to study the effects, both good and bad, of calcineurin inhibitors and the drug Cozaar (losartan), on kidney function and kidney scarring following a liver transplant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2004

Typical duration for phase_4

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

December 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

January 6, 2012

Status Verified

January 1, 2012

Enrollment Period

2.7 years

First QC Date

January 10, 2006

Last Update Submit

January 4, 2012

Conditions

Liver Transplant Recipients

Outcome Measures

Primary Outcomes (1)

  • Development of renal dysfunction (measured by iothalamate clearance).

Interventions

CozaarDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Participants who will be undergoing a liver transplant and are between the ages of 18 to 70 years of age.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Losartan

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • K.V. Narayanan Menon, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 12, 2006

Study Start

December 1, 2004

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

January 6, 2012

Record last verified: 2012-01

Locations

US(1)