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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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This study is designed to define groups of patients (among patients with a heart or kidney graft or a glomerular disease and nephrotic range proteinuria) who would either not profit from a therapy with mycophenolate-mofetil (MMF) or need a higher than conventional dose to respond.
Mainly there are 2 possible explanations for inter-patient differences in responsiveness to MMF therapy:
To study the significance of these possible explanations there are 4 objectives in this study:
Objective 1: Since there are no data on SNPs with functional relevance in IMPDH 2 transcript, we will first sequence all 14 exons of this gene in their entirety in 100 gender and age matched healthy individuals.
Objective 2: The functional relevance of a detected SNP will be tested in vitro in a lymphocyte proliferation assay using various MPA concentrations.
Objective 3: These functionally relevant SNPs will be searched in patients with kidney graft in a retrospective as well as prospective manner.
Objective 4: Parallel to the genotyping experiments, IMPDH 2 activity and MPA plasma levels will be measured in all patients recruited in the study prospectively.
An association between these SNPs or various IMPDH 2 activity / MPA plasma levels with MMF responsiveness will be examined.
Objective 5: Strongyloides IgG titers are screened to evaluate the prevalence of helminth carriers in patients with immunosuppressive therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MPA SNP | Genetic | Functional relevant MPA SNP will be sought in patients DNA isolated from leucocytes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of functionally relevant SNPs in IMPDH 2 gene. | 6 months | |
| The association of detected SNPs in inosine monophosphate dehydrogenase-2 transcript or high IMPDH 2 activity with the lack of response to MPA therapy defined as - number of biopsy proven acute rejections in the first year after transplantation | 12 months per patient |
| Measure | Description | Time Frame |
|---|---|---|
| Screening for strongyloides IgG titers | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a de novo kidney transplantation
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| Name | Affiliation | Role |
|---|---|---|
| Gürkan Sengölge, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine III, Division of Nephrology | Vienna | A-1090 | Austria |
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