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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02587052

Acronym

GenTac

Enrollment

186

Registered

2015-10-27

Start date

2015-10-31

Completion date

2016-12-31

Last updated

2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplantation

Keywords

biopsy-proven acute rejection, graft loss, graft survival

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.

Interventions

DRUGGeneric tacrolimus

Generic tacrolimus

DRUGPrograf

Prograf, the original tacrolimus

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Biopsy-proven acute rejection (BPAR)	1 year
Graft loss	1 year
Death	1 year

Secondary

Measure	Time frame
Tacrolimus dose at day of discharge	day of discharge, approx 7 days
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
Tacrolimus levels at day of discharge	day of discharge, approx 7 days
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026