Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-01-31

Brief Summary

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Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes and determine the proportion of pancreas-kidney transplant recipients who experience any GI complaints under MMF-based immunosuppressive treatment.

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Detailed Description

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Conditions

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Pancreas Transplantation Kidney Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Enteric-coated mycophenolate sodium (EC-MPS)

Intervention Type DRUG

Experimental

Interventions

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Enteric-coated mycophenolate sodium (EC-MPS)

Experimental

Intervention Type DRUG

Other Intervention Names

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myfortic

Eligibility Criteria

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Inclusion Criteria

* Received simultaneous pancreas-kidney (SPK) transplant at least 3 months prior to study enrollment
* Receiving immunosuppressive regimen that includes MMF in combination with other immunosuppressive drugs (i.e., a calcineurin inhibitor, a mTOR inhibitor, steroids at least for three months at time of study enrollment)
* Receiving MMF for at least 1 month prior to enrollment; maximal MMF dose 2000 mg/d.

Exclusion Criteria

* Patients with any known hypersensitivity to mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or other components of the formulations (e.g. lactose; see also SCP of EC-MPS)
* If applicable, GI symptoms assumed or known to be induced by other drugs or infections (e.g. oral biphosphonates induced, infectious diarrhea)
* Acute rejection \< 1 month prior to study enrollment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No