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

NCT02587052 | Completed

• 1 other identifier: 2015-08-01
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplantation

Keywords

biopsy-proven acute rejection; graft loss; graft survival

Outcome Measures

Primary Outcomes (3)

• Biopsy-proven acute rejection (BPAR)

  1 year

• Graft loss

  1 year

• Death

  1 year

Secondary Outcomes (5)

• 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

Study Arms (2)

Tacrolimus

100 patients treated with generic tacrolimus

Drug: Generic tacrolimus

Prograf

100 patients treated with Prograf

Drug: Prograf

Interventions

Generic tacrolimus DRUG

Generic tacrolimus

Tacrolimus

Prograf DRUG

Prograf, the original tacrolimus

Prograf

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Multi-organ transplants
• Re-transplantations

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Transplant Institute, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Per Lindnér, MD

  Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 27, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 3, 2021

Record last verified: 2020-12

Locations

SE (1)