A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis, GenTac

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-12-31

Brief Summary

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This is a retrospective analysis of two different cohorts of patients that has undergone renal transplantation. This is a matched pair analysis of 100 patients treated with generic tacrolimus that will be compared with 100 matched controls treated with Prograf. Data will be obtained from patients' charts, from the Swedish National Kidney Registry and from a local registry at Transplantationscentrum. Patients included in the study are patients receiving a first single kidney transplant from a deceased or a living donor, treated with Prograf or Tacni and transplanted between transplanted January 2012 and August 2014. The 1-year-outcome of patients following renal transplantation, including BPAR, serious adverse effects and graft survival will be analysed.

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Detailed Description

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Conditions

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Renal Transplantation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Tacrolimus

100 patients treated with generic tacrolimus

Generic tacrolimus

Intervention Type DRUG

Generic tacrolimus

Prograf

100 patients treated with Prograf

Prograf

Intervention Type DRUG

Prograf, the original tacrolimus

Interventions

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Generic tacrolimus

Intervention Type DRUG

Prograf

Prograf, the original tacrolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients receiving a first single kidney transplant from a deceased or a living donor.
* Patients treated with Prograf or or generic tacrolimus
* Patients transplanted between 1 October 2012 and 1 August 2014