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

Sandoz102 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

102

Conditions

Chronic Kidney Insufficiency

Interventions

In this observational study no study specific intervention is plannedOTHER

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

General Hospital

Vienna, Austria

Outcomes

Primary Outcomes

Changes in Adport Sandoz© trough level

Time frame: Observation time: 26 weeks

Secondary Outcomes

Time frame: Observation time: 26 weeks

Incidence of serious adverse drug reactions

Time frame: Observation time: 26 weeks

Incidence of adverse drug reactions

Time frame: Observation time: 26 weeks

Incidence of serious adverse events

Time frame: Observation time: 26weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.