Trial Outcomes & Findings for Polycystic Liver Disease in Kidney Transplant (NCT NCT00934791)

Results Overview

Liver volume at 2 years will be compared between the sirolimus and control (tacrolimus) groups using analysis of covariance (ANCOVA).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

2 years

Results posted on

2013-03-08

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Control Group Tacrolimus, mycophenolate mofetil, and prednisone	Sirolimus Group Sirolimus, mycophenolate mofetil, and prednisone
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Tacrolimus, mycophenolate mofetil, and prednisone	Sirolimus Group Sirolimus, mycophenolate mofetil, and prednisone
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Polycystic Liver Disease in Kidney Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=1 Participants Tacrolimus, mycophenolate mofetil, and prednisone	Sirolimus Group Sirolimus, mycophenolate mofetil, and prednisone	Total n=1 Participants Total of all reporting groups
Age Categorical <=18 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age Categorical Between 18 and 65 years	1 participants n=5 Participants	—	1 participants n=5 Participants
Age Categorical >=65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Gender Female	0 participants n=5 Participants	—	0 participants n=5 Participants
Gender Male	1 participants n=5 Participants	—	1 participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: This study was terminated due to inadequate enrollment, no data was collected on the participant.

Liver volume at 2 years will be compared between the sirolimus and control (tacrolimus) groups using analysis of covariance (ANCOVA).

Outcome measures

Outcome data not reported

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sirolimus Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Patrick G. Dean

Mayo Clinic

Phone: 507-266-6953

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place