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Polycystic Liver Disease in Kidney Transplant

NCT00934791 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2013-03-08

Study results available
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Summary

The purpose of this study is to see if one kind of immunosuppressive drug has better effects for the patient's polycystic liver disease than another type. Tacrolimus and Sirolimus are the two immunosuppressive drugs that will be compared for this study. Both drugs have been commonly prescribed to prevent rejection.

Conditions

  • Polycystic Liver Disease

Interventions

DRUG

Tacrolimus

Tacrolimus 6-10 mg/day (maintain trough levels of 8-10 ng/mL)

DRUG

Sirolimus

Sirolimus 3-5 mg/day (maintain high-performance liquid chromatography (HPLC) blood level 10-15 ng/mL)

DRUG

Mycophenolate Mofetil

Mycophenolate Mofetil 750 mg twice daily

DRUG

Prednisone

Prednisone tapered to 5 mg/day by day 92

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Patrick Dean, M.D. · Mayo Clinic

  • QI Qian, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00934791 on ClinicalTrials.gov