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NCT02587052 Clinical Trial

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

Renal Transplantation Clinical Trial

— GenTac  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02587052
Other study ID # 2015-08-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2015
Est. completion date December 2016

Study information
Verified date December 2020
Source Vastra Gotaland Region
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 186
Est. completion date December 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Generic tacrolimus
Generic tacrolimus
• Prograf
Prograf, the original tacrolimus

Locations
Country Name City State
Sweden Transplant Institute, Sahlgrenska University Hospital Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Biopsy-proven acute rejection (BPAR) 1 year
Primary Graft loss 1 year
Primary Death 1 year
Secondary 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
Secondary Compare serious adverse events at 12 months in the two groups 1 year
Secondary Compare the the cost of admissions for rejection treatment in the two groups 1 year
Secondary Tacrolimus dose at day of discharge day of discharge, approx 7 days
Secondary Tacrolimus levels at day of discharge day of discharge, approx 7 days
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