Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus | 100 patients treated with generic tacrolimus |
| |
| Prograf | 100 patients treated with Prograf |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Generic tacrolimus | Drug | Generic tacrolimus |
| |
| Prograf |
| Measure | Description | Time Frame |
|---|---|---|
| Biopsy-proven acute rejection (BPAR) | 1 year | |
| Graft loss | 1 year | |
| Death | 1 year |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Per Lindnér, MD | Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Transplant Institute, Sahlgrenska University Hospital | Gothenburg | 41345 | Sweden |
Not provided
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Prograf, the original tacrolimus |
|
| 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 |