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OpenTrials
Completed

NCT Number: NCT01353417

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

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.

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Key information

Conditions

Chronic Kidney Insufficiency Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In this observational study no study specific intervention is planned

Other

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.

Primary outcomes

  1. Changes in Adport Sandoz© trough level

    Time frame: Observation time: 26 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 13, 2011
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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