Kidney Transplantation, Pancreas Transplantation
Conditions
Keywords
Simultaneous Pancreas-Kidney Transplantation, mycophenolate, GI problems
Brief summary
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.
Interventions
DRUGEnteric-coated mycophenolate sodium (EC-MPS)
Experimental
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium | weeks 6-8 | The Gastrointestinal symptom rating scale (GSRS) is a 15-item instrument designed to assess the symptoms associated with common gastrointestinal disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation,abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores. The primary analysis examined changes from Visit 1 (baseline) to Visit 2 (6-8 weeks) by computing the difference of GSRS total score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy | week 0 | Assessed by GI complications at baseline. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enteric Coated Mycophenolate-sodium Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks. | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Enteric Coated Mycophenolate-sodium |
|---|---|
| Age Continuous | 48.9 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium
The Gastrointestinal symptom rating scale (GSRS) is a 15-item instrument designed to assess the symptoms associated with common gastrointestinal disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation,abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores. The primary analysis examined changes from Visit 1 (baseline) to Visit 2 (6-8 weeks) by computing the difference of GSRS total score.
Time frame: weeks 6-8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enteric Coated Mycophenolate-sodium | Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium | -0.46 Change in Score of GSRS | Standard Deviation 0.71 |
Secondary
Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy
Assessed by GI complications at baseline.
Time frame: week 0
Population: Baseline population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enteric Coated Mycophenolate-sodium | Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy | Any complication | 19 Participants |
| Enteric Coated Mycophenolate-sodium | Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy | Diarrhea | 12 Participants |
| Enteric Coated Mycophenolate-sodium | Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy | Dyspepsia | 4 Participants |
| Enteric Coated Mycophenolate-sodium | Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy | Nausea | 3 Participants |
| Enteric Coated Mycophenolate-sodium | Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy | Abdominal pain/bloating/fullness | 11 Participants |
| Enteric Coated Mycophenolate-sodium | Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy | Other | 1 Participants |