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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: Generic tacrolimus
* Drug: Prograf


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Exclusion Criteria: Multi-organ transplants Re-transplantations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tacrolimus<br>100 patients treated with generic tacrolimus | Drug: Generic tacrolimus<br>* Generic tacrolimus<br>|
| Prograf<br>100 patients treated with Prograf | Drug: Prograf<br>* Prograf, the original tacrolimus<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy-proven acute rejection (BPAR) |  | 1 year | 
| Graft loss |  | 1 year | 
| Death |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the following parameters in the two groups • Graft survival at 6 and 12 months • BPAR at 6 and 12 months • Calculated GFR at 12 months |  | 6 months, and 1 year | 
| Compare serious adverse events at 12 months in the two groups |  | 1 year | 
| Compare the the cost of admissions for rejection treatment in the two groups |  | 1 year | 
| Tacrolimus dose at day of discharge |  | day of discharge, approx 7 days | 
| Tacrolimus levels at day of discharge |  | day of discharge, approx 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biopsy-proven acute rejection, graft loss, graft survival