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Trial record 59 of 1164 for:    MYCOPHENOLIC ACID

Mycophenolic Acid (MPA) Monotherapy in Liver Transplantation

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ClinicalTrials.gov Identifier: NCT01230502
Recruitment Status : Terminated (insufficient study population to meet study objective)
First Posted : October 29, 2010
Results First Posted : May 7, 2014
Last Update Posted : May 7, 2014
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Liver Transplant
Interventions Drug: Group 1 Donor Specific Regulation (DSR) +, Mycophenolic acid (MPA) monotherapy
Other: data and sample collection
Enrollment 11
Recruitment Details  
Pre-assignment Details 11 participants consented and were enrolled in the study. However, 2 of the subjects screen failed and did not participate in the study beyond providing their consent to participate. Thus only 9 subjects consented to and "started" the study and these 9 subjects are analyzed in the results.
Arm/Group Title Group 3: Donor Specific Regulation (DSR) -, Standard of Care Group 2 Donor Specific Regulation (DSR) +; Standard of Care Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy
Hide Arm/Group Description

Subjects who test Donor specific regulation (DSR) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.

data and sample collection: Group 3 : DSR (-) standard of care:

These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months.

Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.

data and sample collection: Group 2 : DSR (+)standard of care:

These subjects will be maintained on standard of care immunosuppression consisting of Tacrolimus and Mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.

Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples

Subjects that are Donor specific regulation (DSR) positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive

Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:

Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.

Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.

Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples.

Period Title: Overall Study
Started 9 0 0
Completed 9 0 0
Not Completed 0 0 0
Arm/Group Title Group 3: Donor Specific Regulation DSR -, Standard of Care Group 2 Donor Specific Regulation DSR +; Standard of Care Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy Total
Hide Arm/Group Description

Subjects who test DSR (donor specific regulation) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.

data and sample collection: Group 3 : DSR(-) standard of care:

These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months.

Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.

data and sample collection: Group 2 : DSR(+) standard of care:

These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.

Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples

Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive

Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:

Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.

Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.

Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples.

Total of all reporting groups
Overall Number of Baseline Participants 9 0 0 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 0 participants 0 participants 9 participants
51  (14.757) 51  (14.76)
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 0 participants 0 participants 9 participants
<=18 years 0 0
Between 18 and 65 years 8 8
>=65 years 1 1
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 0 participants 0 participants 9 participants
Female 3 3
Male 6 6
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 0 participants 0 participants 9 participants
9 9
1.Primary Outcome
Title Modification of Diet in Renal Disease (MDRD) Estimation of Glomerular Filtration Rate (GFR)
Hide Description

This outcome measure is used to determine if the reduction of calcineurin inhibitor immunosuppression leads to improved native kidney function. Native kidney function is assessed using the Modification of Diet in Renal Disease (MDRD) estimation of glomerular filtration rate (GFR) from serum or plasma creatinine samples at the reported time points.

Reference intervals include:

Healthy 18 years and up: 60-120 mL/min/1.73 sqm Chronic kidney disease: GFR < 60 mL/min/1.73 sqm Kidney failure: GFR < 15 mL/min/1.73 sqm

Time Frame 6 months post enrollment/randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 3: DSR (-), Standard of Care Group 2 DSR (+); Standard of Care Group 1 DSR (+), Withdrawal of Tacrolimus to MPA Monotherapy
Hide Arm/Group Description:

Subjects who test DSR negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.

data and sample collection: Group 3 : DSR (-) standard of care:

These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months.

Subjects that are DSR positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.

data and sample collection: Group 2 : DSR (+)standard of care:

These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.

Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples

Subjects that are DSR positive and randomized (1:1)to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive

Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:

Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.

Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.

Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples.

Overall Number of Participants Analyzed 7 0 0
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73 sqm
60.14  (16.39)
2.Primary Outcome
Title Modification of Diet in Renal Disease (MDRD) Estimation of Glomerular Filtration Rate (GFR)
Hide Description

This outcome measure is used to determine if the reduction of calcineurin inhibitor immunosuppression leads to improved native kidney function. Native kidney function is assessed using the Modification of Diet in Renal Disease (MDRD) estimation of glomerular filtration rate (GFR) from serum or plasma creatinine samples at the reported time points.

Reference intervals include:

Healthy 18 years and up: 60-120 mL/min/1.73 sqm Chronic kidney disease: GFR < 60 mL/min/1.73 sqm Kidney failure: GFR < 15 mL/min/1.73 sqm

Time Frame 12 months post enrollment/randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 3: Donor Specific Regulation (DSR) -, Standard of Care Group 2 Donor Specific Regulation (DSR) +; Standard of Care Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy
Hide Arm/Group Description:

Subjects who test DSR negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.

data and sample collection: Group 3 : DSR (-) standard of care:

These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months.

Subjects that are DSR positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.

data and sample collection: Group 2 : DSR (+)standard of care:

These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.

Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples

Subjects that are DSR positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive

Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:

Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.

Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.

Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples.

Overall Number of Participants Analyzed 5 0 0
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73 sqm
82.4  (28.34)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 3: DSR (Donor Specific Regulation) (-), Standard of Care Group 2 DSR (Donor Specific Regulation) (+); Standard of Care Group 1 DSR (Donor Specific Regulation) (+),MPA Monotherapy
Hide Arm/Group Description

Subjects who test Donor specific regulation (DSR) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.

data and sample collection: Group 3 : DSR(-) standard of care:

These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months.

Subjects that are Donor specific regulation (DSR) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.

data and sample collection: Group 2 : DSR(+) standard of care:

These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.

Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples

Subjects that are Donor specific regulation DSR positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive

Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:

Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.

Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.

Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples.

All-Cause Mortality
Group 3: DSR (Donor Specific Regulation) (-), Standard of Care Group 2 DSR (Donor Specific Regulation) (+); Standard of Care Group 1 DSR (Donor Specific Regulation) (+),MPA Monotherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 3: DSR (Donor Specific Regulation) (-), Standard of Care Group 2 DSR (Donor Specific Regulation) (+); Standard of Care Group 1 DSR (Donor Specific Regulation) (+),MPA Monotherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 3: DSR (Donor Specific Regulation) (-), Standard of Care Group 2 DSR (Donor Specific Regulation) (+); Standard of Care Group 1 DSR (Donor Specific Regulation) (+),MPA Monotherapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PI, or his designee, must notify the sponsor at least (10) days, if possible, or as soon as possible, prior to submitting this information.
Results Point of Contact
Name/Title: Professor William Burlingham, PhD
Organization: University of Wisconsin
Phone: (608) 263-0119
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01230502     History of Changes
Other Study ID Numbers: UW H-2010-0121
CERL080AUS80T ( Other Grant/Funding Number: Novartis Pharmaceuticals )
First Submitted: October 27, 2010
First Posted: October 29, 2010
Results First Submitted: February 24, 2014
Results First Posted: May 7, 2014
Last Update Posted: May 7, 2014