Polyomavirus BK nephropathy after renal transplantation: Randomized clinical trial to demonstrate that switching to mTOR inhibitor is more effective than a reduction of immunosuppressive therapy - POLYOMA STUDY
Phase 1
- Conditions
- Polyoma BK-virus nephropathy is a viral complication after renal transplantation attacking up to 10% of renal transplants and causing transplant failure in 45% of cases. No virustatic treatment exists. Modifying the infection is usually tried by lowering immunosuppression, which may lead to transplant failure by rejection as well. A randomized switch of immunosuppression to everolimus vs general lowering of immunosuppression has to be tested (prospect. random. parallel group comparison).
- Registration Number
- EUCTR2008-005925-12-DE
- Lead Sponsor
- Medizinische Hochschule Hannover
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Preceding transplantation;
functioning graft with a permanent glomerular filtration rate of >30mL/min; bioptically confirmed polyomavirus BK nephropathy;
age of 19 - 75 years;
written consent of the patient.
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
Pregnancy;
known intolerance of the planned medication (e.g. severe diarrhea, angioedema, severe wound healing problem, uncontrolled infectious diseases other than BK virus);
leucopenia <2000/µL;
permanent glomerular filtration rate of <30mL/min.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method