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Completed

NCT Number: NCT02587052

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

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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Key information

Conditions

Renal Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Transplant Institute, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Generic Tacrolimus

Drug

Generic tacrolimus

Prograf

Drug

Prograf, the original tacrolimus

Primary outcomes

  1. Biopsy-proven acute rejection (BPAR)

    Time frame: 1 year

  2. Graft loss

    Time frame: 1 year

  3. Death

    Time frame: 1 year

Secondary outcomes

  1. 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

    Time frame: 6 months, and 1 year

  2. Compare serious adverse events at 12 months in the two groups

    Time frame: 1 year

  3. Compare the the cost of admissions for rejection treatment in the two groups

    Time frame: 1 year

  4. Tacrolimus dose at day of discharge

    Time frame: day of discharge, approx 7 days

  5. Tacrolimus levels at day of discharge

    Time frame: day of discharge, approx 7 days

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Acronym: GenTac

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 27, 2015
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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