Identification of patients with high probability of not or poorly responding to therapy with mycophenolic acid pro-drugs.
Phase 1
- Conditions
- Patients with a de novo kidney transplantationMedDRA version: 12.0Level: LLTClassification code 10023438Term: Kidney transplant
- Registration Number
- EUCTR2009-014997-16-AT
- Lead Sponsor
- Medizinische Universität Wien, Abteilung für Nephrologie und Dialyse
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
de novo kidney graft
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
highly immunized patients (due to previous transplantations etc) with PRA levels >40%
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Detection of functionally relevant SNPs in IMPDH 2 gene.;Secondary Objective: The association of detected SNPs in inosine monophosphate dehydrogenase-2 transcript or high IMPDH 2 activity with biopsy proven rejection reactions in the first year after transplantation.;Primary end point(s): Biopsy proven rejection
- Secondary Outcome Measures
Name Time Method