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

Sandoz

Status: Completed

Conditions: Chronic Kidney Insufficiency

Treatments: Other: In this observational study no study specific intervention is planned

Study type: Observational

Funder types: Industry

Identifiers

NCT01353417

TAC SAN NIS 2011

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

102 participants in 1 patient group

Renal allograft

Treatment:

Other: In this observational study no study specific intervention is planned