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Polycystic Liver Disease in Kidney Transplant

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ClinicalTrials.gov Identifier: NCT00934791
Recruitment Status : Terminated (Terminated due to inadequate enrollment)
First Posted : July 8, 2009
Results First Posted : March 8, 2013
Last Update Posted : March 8, 2013
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Patrick G. Dean, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Polycystic Liver Disease
Interventions Drug: Tacrolimus
Drug: Sirolimus
Drug: Mycophenolate Mofetil
Drug: Prednisone
Enrollment 2
Recruitment Details Two participants were enrolled in the study in Rochester, Minnesota. One participant withdrew before doing any part of the study; he was not randomized to a group.
Pre-assignment Details  
Arm/Group Title Control Group Sirolimus Group
Hide Arm/Group Description Tacrolimus, mycophenolate mofetil, and prednisone Sirolimus, mycophenolate mofetil, and prednisone
Period Title: Overall Study
Started 1 0
Completed 0 0
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Control Group Sirolimus Group Total
Hide Arm/Group Description Tacrolimus, mycophenolate mofetil, and prednisone Sirolimus, mycophenolate mofetil, and prednisone Total of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
<=18 years 0 0
Between 18 and 65 years 1 1
>=65 years 0 0
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female 0 0
Male 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 1 participants
1 1
1.Primary Outcome
Title Liver Volume at 2 Years After Kidney Transplantation
Hide Description Liver volume at 2 years will be compared between the sirolimus and control (tacrolimus) groups using analysis of covariance (ANCOVA).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated due to inadequate enrollment, no data was collected on the participant.
Arm/Group Title Control Group Sirolimus Group
Hide Arm/Group Description:
Tacrolimus, mycophenolate mofetil, and prednisone
Sirolimus, mycophenolate mofetil, and prednisone
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Sirolimus Group
Hide Arm/Group Description Tacrolimus, mycophenolate mofetil, and prednisone Sirolimus, mycophenolate mofetil, and prednisone
All-Cause Mortality
Control Group Sirolimus Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group Sirolimus Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group Sirolimus Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
This study was terminated due to inadequate enrollment, no data was collected on the participant.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Patrick G. Dean
Organization: Mayo Clinic
Phone: 507-266-6953
EMail: dean.patrick2@mayo.edu
Layout table for additonal information
Responsible Party: Patrick G. Dean, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00934791     History of Changes
Other Study ID Numbers: 08-004315
First Submitted: July 6, 2009
First Posted: July 8, 2009
Results First Submitted: February 4, 2013
Results First Posted: March 8, 2013
Last Update Posted: March 8, 2013