Non-interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Renal Graft Rejection
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.
1 other identifier
observational
102
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 12, 2011
CompletedFirst Posted
Study publicly available on registry
May 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2015
CompletedApril 7, 2017
April 1, 2017
4.4 years
May 12, 2011
April 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Adport Sandoz© trough level
Observation time: 26 weeks
Secondary Outcomes (4)
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
Study Arms (1)
Renal allograft
Interventions
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
Patients after renal transplantation who are treated in the general hospital of Vienna on an outpatient basis
You may qualify if:
- 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)
- Written and oral informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sandozlead
Study Sites (1)
General Hospital
Vienna, 1090, Austria
Biospecimen
Retained types of biospecimen: whole blood, serum, urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2011
First Posted
May 13, 2011
Study Start
April 1, 2011
Primary Completion
August 31, 2015
Study Completion
August 31, 2015
Last Updated
April 7, 2017
Record last verified: 2017-04