NCT01353417
Completed
Not Applicable
A Single-site, Prospective Non-interventional-study With Adport Sandoz© Capsules for Prophylaxis of Graft Rejection in Patients With Stable Kidney Function After Renal Allograft.
ConditionsChronic Kidney Insufficiency
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sandoz
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Changes in Adport Sandoz© trough level
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Changes in Adport Sandoz© trough level
Time Frame: Observation time: 26 weeks
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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