Renal TransplantationGenTacNCT02587052
A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis, GenTac
An observational study of Renal Transplantation, run by Vastra Gotaland Region at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Generic tacrolimus and Prograf
- How many people
- 186 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Multi-organ transplants
- Re-transplantations
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Transplant Institute, Sahlgrenska University Hospital
Gothenburg, 41345
About this study
Official title: A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis
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
- Being tested
- Generic tacrolimus, Prograf
- Keywords
- biopsy-proven acute rejection, graft loss, graft survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic tacrolimusDrug
Generic tacrolimus
PrografDrug
Prograf, the original tacrolimus
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus | 100 patients treated with generic tacrolimus Receives: Drug: Generic tacrolimus | |
| Prograf | 100 patients treated with Prograf Receives: Drug: Prograf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy-proven acute rejection (BPAR)
Measured: 1 year
Graft loss
Measured: 1 year
Death
Measured: 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
Measured: 6 months, and 1 year
Compare serious adverse events at 12 months in the two groups
Measured: 1 year
Compare the the cost of admissions for rejection treatment in the two groups
Measured: 1 year
Tacrolimus dose at day of discharge
Measured: day of discharge, approx 7 days
Tacrolimus levels at day of discharge
Measured: day of discharge, approx 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Per Lindnér, MD, Principal investigator, Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587052
- Sponsor's protocol ID
- 2015-08-01
- Acronym
- GenTac
- Status last verified
- Dec 2020
- First submitted
- 19 Oct 2015
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis
- ClinicalTrials.gov ID
- NCT02587052
- Acronym / sponsor ID
- GenTac / 2015-08-01
- Conditions
- Renal Transplantation
- Keywords
- biopsy-proven acute rejection, graft loss, graft survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus | – | Drug: Generic tacrolimus100 patients treated with generic tacrolimus |
| Prograf | – | Drug: Prograf100 patients treated with Prograf |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Multi-organ transplants
- Re-transplantations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Generic tacrolimusGeneric tacrolimus | Drug | Tacrolimus |
| PrografPrograf, the original tacrolimus | Drug | Prograf |
Primary outcome
Biopsy-proven acute rejection (BPAR)
Time frame: 1 year
Graft loss
Time frame: 1 year
Death
Time frame: 1 year
5 secondary outcomes
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
Time frame: 6 months, and 1 year
Compare serious adverse events at 12 months in the two groups
Time frame: 1 year
Compare the the cost of admissions for rejection treatment in the two groups
Time frame: 1 year
Tacrolimus dose at day of discharge
Time frame: day of discharge, approx 7 days
Tacrolimus levels at day of discharge
Time frame: day of discharge, approx 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
Related trials for Renal Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Lindnér, MD principal investigator
Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplantation, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biopsy-proven acute rejection (BPAR) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.