Non-interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Renal Graft Rejection
Completed
- Conditions
- Chronic Kidney Insufficiency
- Interventions
- Other: In this observational study no study specific intervention is planned
- Registration Number
- NCT01353417
- Lead Sponsor
- Sandoz
- Brief Summary
This non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the approved indication.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
Inclusion Criteria
- Age: ≥ 18
- Post renal transplantation time: ≥ 6 months
- Stable kidney function ( serum creatinine < 3.0mg/dl; variation < 0.5mg/dl at 2 appointments in minimum distance of 6 days)
- Stable Tacrolimus Sandoz© dose > 2 weeks before inclusion in this Non Interventional Study (NIS)
- Written and oral informed consent
Exclusion Criteria
- Well-known poor compliance with immunosuppressives
- Acute rejection reaction within the past 3 months or antibody-therapy because of rejection within the past 6 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Renal allograft In this observational study no study specific intervention is planned -
- Primary Outcome Measures
Name Time Method Changes in Adport Sandoz© trough level Observation time: 26 weeks
- Secondary Outcome Measures
Name Time Method Incidence of adverse drug reactions Observation time: 26 weeks Efficacy of Adport Sandoz© in prevention of renal graft rejection by observing serum creatinine levels Observation time: 26 weeks Incidence of serious adverse drug reactions Observation time: 26 weeks Incidence of serious adverse events Observation time: 26weeks
Trial Locations
- Locations (1)
General Hospital
🇦🇹Vienna, Austria