End Stage Renal DiseasePhase 4GenTacNCT01698541
Generic Tacrolimus in the Elderly - Prograf® vs Tacni®
A Phase 4 study testing Tacrolimus in people with End Stage Renal Disease, run by University of Oslo School of Pharmacy at 1 site in Norway.
Trial summary
Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as comparator, in elderly (>60 yr) renal transplant recipients Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2013to Nov 2013
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal transplant recipients that will receive Tac as part of their immunosuppressive therapy.
- Recipients 60 years of age or older.
- Signed informed consent.
Who cannot join
- Diabetes mellitus (WHO criteria).
- Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepin, fluconazole, ketoconazole, voriconazole, erythromycin, clarithromycin.
Trial locations and contacts
1 site in 1 country.
About this study
Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as comparator, in elderly (>60 yr) renal transplant recipients
Read the detailed description
12-hour pharmacokinetic investigations performed on each formulation in each patient at steady-state. Patients will be randomized with regards to which formulation to start with. 1-2 weeks between each PK investigation.
- Conditions
- End Stage Renal Disease
- Being tested
- Tacrolimus
- Keywords
- Renal, Transplantation, Elderly
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Tacrolimus formualted as the generic Tacni
Tested generic
TacrolimusDrug
Also called Tacrolimus formualted as the original Prograf
Original formulation used as comparator
| Study group | Role | What they receive |
|---|---|---|
| Tacni | Experimental | Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center Receives: Drug: Tacrolimus |
| Prograf | Active comparator | Tacrolimus administered as Prograf in according to standard protocol at the transplant center Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Bioequivalence will be assessed at steady-state by comparing both AUC(0-12) and Cmax ratios for generic:original-ratios and applying the stricter 90-111% bioequivalence criteria.
AUC(0-12) will be assessed by trapezoidal rule and Cmax will be the highest actually measured concentration.
Measured: 10 weeks
Secondary outcomes (1)
Population model validation
Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startFeb 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo School of Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Anders Åsberg, University of Oslo School of Pharmacy
- Investigators
- Anders Åsberg, PhD, Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698541
- Sponsor's protocol ID
- GenTac-12
- Acronym
- GenTac
- Status last verified
- Dec 2014
- First submitted
- 21 Sep 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generic Tacrolimus in the Elderly - Prograf® vs Tacni®
- ClinicalTrials.gov ID
- NCT01698541
- Acronym / sponsor ID
- GenTac / GenTac-12
- Conditions
- End Stage Renal Disease
- Keywords
- Renal, Transplantation, Elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Oslo School of PharmacyUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Feb 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 3 Oct 2012 (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.
Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as comparator, in elderly (>60 yr) renal transplant recipients
Detailed description
12-hour pharmacokinetic investigations performed on each formulation in each patient at steady-state. Patients will be randomized with regards to which formulation to start with. 1-2 weeks between each PK investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacni | Experimental | Drug: TacrolimusTacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center |
| Prograf | Active comparator | Drug: TacrolimusTacrolimus administered as Prograf in according to standard protocol at the transplant center |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Renal transplant recipients that will receive Tac as part of their immunosuppressive therapy.
- Recipients 60 years of age or older.
- Signed informed consent.
Key exclusion criteria (2 listed)
- Diabetes mellitus (WHO criteria).
- Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepin, fluconazole, ketoconazole, voriconazole, erythromycin, clarithromycin.
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 |
|---|---|---|
| TacrolimusAlso: Tacrolimus formualted as the generic TacniTested generic | Drug | Prograf, Tacni |
| TacrolimusAlso: Tacrolimus formualted as the original PrografOriginal formulation used as comparator | Drug | Prograf, Tacni |
Primary outcome
Bioequivalence
Time frame: 10 weeks
Bioequivalence will be assessed at steady-state by comparing both AUC(0-12) and Cmax ratios for generic:original-ratios and applying the stricter 90-111% bioequivalence criteria. AUC(0-12) will be assessed by trapezoidal rule and Cmax will be the highest actually measured concentration.
1 secondary outcome
Population model validation
Time frame: 10 weeks
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 Dec 2014.
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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.
Anders Åsberg, PhD study chair
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus in people with End Stage Renal Disease, run by University of Oslo School of Pharmacy at 1 site in Norway.
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 Dec 2014. 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 Norway. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bioequivalence (time frame: 10 weeks). 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 Dec 2014.