A multi-center non-interventional study (NIS) to assess practicability, effectiveness and tolerability of once daily applied tacrolimus formulations used in kidney transplant patients.
- Conditions
- Immunosuppression after kidney transplantationZ94Transplanted organ and tissue status
- Registration Number
- DRKS00011124
- Lead Sponsor
- Chiesi GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 47
Inclusion Criteria
1. Adult male or female kidney transplant recipients 0-10 days after transplantation with an indication for immunosuppression therapy according to the latest Envarsus®/Advagraf® SmPC.
2. Treatment with once daily tacrolimus at time of inclusion into the study. Patients must have received at least the first dose of once daily tacrolimus prior to giving consent.
3. Patient’s signed informed consent.
Exclusion Criteria
1. Patients will be excluded from the study according to contraindications, restrictions and precautions described in the Envarsus®/Advagraf® SmPC.
2. Recipients of any transplanted organ other than kidney.
3. Recipients positive for HIV.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method