Clinical trial NCT02587052: A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis, GenTac
Official title: A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Transplantation
Keywords: biopsy-proven acute rejection
graft loss
graft survival
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2015-10-27
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Biopsy-proven acute rejection (BPAR)
timeFrame: 1 year
measure: Graft loss
timeFrame: 1 year
measure: Death
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 6 months, and 1 year
measure: Compare serious adverse events at 12 months in the two groups
timeFrame: 1 year
measure: Compare the the cost of admissions for rejection treatment in the two groups
timeFrame: 1 year
measure: Tacrolimus dose at day of discharge
timeFrame: day of discharge, approx 7 days
measure: Tacrolimus levels at day of discharge
timeFrame: day of discharge, approx 7 days
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Transplant Institute, Sahlgrenska University Hospital
Study officials:
affiliation: Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden
name: Per Lindnér, MD
role: PRINCIPAL_INVESTIGATOR
References: