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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
  Purpose

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 Adport 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 Adport Sandoz© trough level [ Time Frame: Observation time: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353417

Locations
Austria
General Hospital Recruiting
Vienna, Austria, 1090
Contact: Gere Sunder-Plassmann, Professor, M.D.    +0043 (0) 1 40400 ext 4390    gere.sunder-plassmann@meduniwien.ac.at   
Contact: Alice Schmidt, Professor, M.D.       alice.schmidt@meduniwien.ac.at   
Sponsors and Collaborators
Sandoz GmbH
  More Information

No publications provided

Responsible Party: Sandoz GmbH
ClinicalTrials.gov Identifier: NCT01353417     History of Changes
Other Study ID Numbers: TAC SAN NIS 2011
Study First Received: May 12, 2011
Last Updated: June 6, 2014
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
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014