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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Sandoz GmbH
Sponsor:
Information provided by (Responsible Party):
Sandoz GmbH
ClinicalTrials.gov Identifier:
NCT01353417
First received: May 12, 2011
Last updated: June 6, 2014
Last verified: June 2014

May 12, 2011
June 6, 2014
April 2011
December 2014   (final data collection date for primary outcome measure)
Changes in Adport Sandoz© trough level [ Time Frame: Observation time: 26 weeks ] [ Designated as safety issue: No ]
Changes in Tacrolimus Sandoz© trough level [ Time Frame: Observation time: 26 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Incidence of serious adverse drug reactions [ Time Frame: Observation time: 26 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of adverse drug reactions [ Time Frame: Observation time: 26 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of serious adverse events [ Time Frame: Observation time: 26weeks ] [ Designated as safety issue: Yes ]
  • Efficacy of Tacrolimus Sandoz© in prevention of renal graft rejection by observing serum creatinine levels [ Time Frame: Observation time: 26 weeks ] [ Designated as safety issue: No ]
  • Incidence of serious adverse drug reactions [ Time Frame: Observation time: 26 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of adverse drug reactions [ Time Frame: Observation time: 26 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of serious adverse events [ Time Frame: Observation time: 26weeks ] [ Designated as safety issue: Yes ]
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.
 
Recruiting
50
December 2014
December 2014   (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 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
Both
18 Years and older
No
Austria
 
NCT01353417
TAC SAN NIS 2011
Yes
Sandoz GmbH
Sandoz GmbH
Not Provided
Not Provided
Sandoz GmbH
June 2014

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