Non-interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Renal Graft Rejection
NCT ID: NCT01353417
Last Updated: 2017-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
102 participants
OBSERVATIONAL
2011-04-30
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Renal allograft
In 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.
Interventions
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In 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Acute rejection reaction within the past 3 months or antibody-therapy because of rejection within the past 6 months
18 Years
ALL
No
Sponsors
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Sandoz
INDUSTRY
Responsible Party
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Locations
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General Hospital
Vienna, , Austria
Countries
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Other Identifiers
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TAC SAN NIS 2011
Identifier Type: -
Identifier Source: org_study_id
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