Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Non-interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Renal Graft Rejection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01353417
First received: May 12, 2011
Last updated: April 5, 2017
Last verified: April 2017

May 12, 2011
April 5, 2017
April 2011
August 31, 2015   (Final data collection date for primary outcome measure)
Changes in Adport Sandoz© trough level [ Time Frame: Observation time: 26 weeks ]
Changes in Tacrolimus Sandoz© trough level [ Time Frame: Observation time: 26 weeks ]
Complete list of historical versions of study NCT01353417 on ClinicalTrials.gov Archive Site
  • Efficacy of Adport Sandoz© in prevention of renal graft rejection by observing serum creatinine levels [ Time Frame: Observation time: 26 weeks ]
  • Incidence of serious adverse drug reactions [ Time Frame: Observation time: 26 weeks ]
  • Incidence of adverse drug reactions [ Time Frame: Observation time: 26 weeks ]
  • Incidence of serious adverse events [ Time Frame: Observation time: 26weeks ]
  • Efficacy of Tacrolimus Sandoz© in prevention of renal graft rejection by observing serum creatinine levels [ Time Frame: Observation time: 26 weeks ]
  • Incidence of serious adverse drug reactions [ Time Frame: Observation time: 26 weeks ]
  • Incidence of adverse drug reactions [ Time Frame: Observation time: 26 weeks ]
  • Incidence of serious adverse events [ Time Frame: Observation time: 26weeks ]
Not Provided
Not Provided
 
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.
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Retained types of biospecimen: whole blood, serum, urine
Non-Probability Sample
Patients after renal transplantation who are treated in the general hospital of Vienna on an outpatient basis
Chronic Kidney Insufficiency
Other: 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.
Renal allograft
Intervention: Other: In this observational study no study specific intervention is planned
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
August 31, 2015
August 31, 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT01353417
TAC SAN NIS 2011
Yes
Not Provided
Not Provided
Not Provided
Sandoz
Sandoz
Not Provided
Not Provided
Sandoz
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP