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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Sandoz GmbH.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Sandoz GmbH Identifier:
First received: May 12, 2011
Last updated: March 12, 2012
Last verified: March 2012

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.

Condition Intervention
Chronic Kidney Insufficiency
Other: In this observational study no study specific intervention is planned

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Single-site, Prospective Non-Interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Graft Rejection in Patients With Stable Kidney Function After Renal Allograft.

Resource links provided by NLM:

Further study details as provided by Sandoz GmbH:

Primary Outcome Measures:
  • Changes in Tacrolimus Sandoz© trough level [ Time Frame: Observation time: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Retained types of biospecimen: whole blood, serum, urine

Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Study Completion Date: February 2013
Groups/Cohorts Assigned Interventions
Renal allograft 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients after renal transplantation who are treated in the general hospital of Vienna on an outpatient basis


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
  Contacts and Locations
Please refer to this study by its identifier: NCT01353417

General Hospital Recruiting
Vienna, Austria, 1090
Contact: Gere Sunder-Plassmann, Professor, M.D.    +0043 (0) 1 40400 ext 4390   
Contact: Alice Schmidt, Professor, M.D.   
Sponsors and Collaborators
Sandoz GmbH
  More Information

No publications provided

Responsible Party: Sandoz GmbH Identifier: NCT01353417     History of Changes
Other Study ID Numbers: TAC SAN NIS 2011
Study First Received: May 12, 2011
Last Updated: March 12, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Sandoz GmbH:
Grafting, kidney
Transplantation, kidney

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014