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

Completed

• Conditions: Renal Transplantation
• Interventions: Drug: Generic tacrolimus; Drug: Prograf

• Registration Number: NCT02587052
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-27
• Primary Completion: 2016-09
• Study Completion: 2016-12
• Status Verified: 2020-12
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tacrolimus	Generic tacrolimus	100 patients treated with generic tacrolimus
Prograf	Prograf	100 patients treated with Prograf

Primary Outcome Measures

Name	Time	Method
Graft loss	1 year
Death	1 year
Biopsy-proven acute rejection (BPAR)	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Transplant Institute, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden