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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Transplantation
• Intervention / Treatment: Drug: Generic tacrolimus; Drug: Prograf

• Study Type: Observational
• Enrollment (Actual): 186

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Transplant Institute, Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

It is a retrospective analysis of two different cohorts of patients that have undergone renal transplantation at Transplanationscentrum in Gothenburg, Sweden. Approximately 100 patients treated with generic tacrolimus will be compared with 100 matched controls. The controls will be selected among 200 patients that are treated with Prograf. The matching will be based upon living/deceased, age of the donor, age of the patient and number of previous transplantations.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tacrolimus; 100 patients treated with generic tacrolimus	Drug: Generic tacrolimus; Generic tacrolimus
Prograf; 100 patients treated with Prograf	Drug: Prograf; Prograf, the original tacrolimus

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Per Lindnér, MD, Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 19, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: graft survival; biopsy-proven acute rejection; graft loss
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: 2015-08-01