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

• Sponsor: Vastra Gotaland Region (Other)
• Overall Status: Completed
• CT.gov ID: NCT02587052
• Collaborator: (none)
• Enrollment: 186
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 13.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Transplantation	Drug: Generic tacrolimus; Drug: Prograf

Study Design

• Study Type: Observational
• Actual Enrollment: 186 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Tacrolimus 100 patients treated with generic tacrolimus	Drug: Generic tacrolimus; Generic tacrolimus
Prograf 100 patients treated with Prograf	Drug: Prograf; Prograf, the original tacrolimus

Outcome Measures

Primary Outcome Measures

1. Biopsy-proven acute rejection (BPAR) [1 year]

2. Graft loss [1 year]

3. Death [1 year]

Secondary Outcome Measures

1. 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]

2. Compare serious adverse events at 12 months in the two groups [1 year]

3. Compare the the cost of admissions for rejection treatment in the two groups [1 year]

4. Tacrolimus dose at day of discharge [day of discharge, approx 7 days]

5. Tacrolimus levels at day of discharge [day of discharge, approx 7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Transplant Institute, Sahlgrenska University Hospital	Gothenburg		Sweden	41345

Sponsors and Collaborators

• Vastra Gotaland Region

Investigators

• Principal Investigator: Per Lindnér, MD, Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vastra Gotaland Region
• ClinicalTrials.gov Identifier: NCT02587052
• Other Study ID Numbers: 2015-08-01
• First Posted: Oct 27, 2015
• Last Update Posted: Feb 3, 2021
• Last Verified: Dec 1, 2020

• Keywords provided by Vastra Gotaland Region: biopsy-proven acute rejection; graft loss; graft survival
• Additional relevant MeSH terms: Tacrolimus

Study Results

No Results Posted as of Feb 3, 2021