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

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ClinicalTrials.gov Identifier: NCT01353417
Recruitment Status : Completed
First Posted : May 13, 2011
Last Update Posted : April 7, 2017
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.
Study Start Date : April 2011
Primary Completion Date : August 31, 2015
Study Completion Date : August 31, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Changes in Adport Sandoz© trough level [ Time Frame: Observation time: 26 weeks ]

Secondary Outcome Measures :
  1. Efficacy of Adport Sandoz© in prevention of renal graft rejection by observing serum creatinine levels [ Time Frame: Observation time: 26 weeks ]
  2. Incidence of serious adverse drug reactions [ Time Frame: Observation time: 26 weeks ]
  3. Incidence of adverse drug reactions [ Time Frame: Observation time: 26 weeks ]
  4. Incidence of serious adverse events [ Time Frame: Observation time: 26weeks ]

Biospecimen Retention:   Samples Without DNA
Retained types of biospecimen: whole blood, serum, urine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353417

General Hospital
Vienna, Austria, 1090
Sponsors and Collaborators
More Information

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01353417     History of Changes
Other Study ID Numbers: TAC SAN NIS 2011
First Posted: May 13, 2011    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017

Keywords provided by Sandoz:
Grafting, kidney
Transplantation, kidney

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action