Chronic Kidney Insufficiency
Conditions
Keywords
Grafting, kidney, Transplantation, kidney
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.
Interventions
OTHERIn this observational study no study specific intervention is planned
Patients with stable kidney function who already receive Tacrolimus Sandoz© capsules before being included in this non-interventional study, are being observed for 6 months by their attending physicians. Routine medical treatment is provided.
Sponsors
Sandoz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Adport Sandoz© trough level | Observation time: 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 adverse drug reactions | Observation time: 26 weeks |
| Incidence of serious adverse events | Observation time: 26weeks |
Countries
Austria
Outcome results
None listed