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

April 5, 2017 updated by: Sandoz

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Adport Sandoz© trough level
Time Frame: Observation time: 26 weeks
Observation time: 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy of Adport Sandoz© in prevention of renal graft rejection by observing serum creatinine levels
Time Frame: Observation time: 26 weeks
Observation time: 26 weeks
Incidence of serious adverse drug reactions
Time Frame: Observation time: 26 weeks
Observation time: 26 weeks
Incidence of adverse drug reactions
Time Frame: Observation time: 26 weeks
Observation time: 26 weeks
Incidence of serious adverse events
Time Frame: Observation time: 26weeks
Observation time: 26weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

August 31, 2015

Study Completion (Actual)

August 31, 2015

Study Registration Dates

First Submitted

May 12, 2011

First Submitted That Met QC Criteria

May 12, 2011

First Posted (Estimate)

May 13, 2011

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAC SAN NIS 2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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