Kidney TransplantPhase 1TODAYNCT03978494
Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients.
A Phase 1 study testing Advagraf® and Generic tacrolimus in people with Kidney Transplant, run by Sandoz at 13 sites in 2 countries.
Trial summary
Study to compare pharmacokinetics of tacrolimus prolonged-release (PR) capsules and Advagraf® PR capsules in stable kidney transplant patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Advagraf® and Generic tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 2 Sep 2019to 3 May 2020
- Phase
- Phase 1
- 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
Who may be able to join
- Male or female patients aged ≥18 years;
- Patients with a Body Mass Index (BMI) included in the interval [18.5-33.0] kg/m²;
- Patients who received a primary kidney transplant at least 12 months prior to study entry
Who cannot join
- Evidence or suspicion of ongoing or persistent, acute or chronic rejection;
- Requirement for dialysis within the six months prior to study entry;
- Glomerular filtration rate (GFR) <30 mL/min
- Pregnant or breastfeeding women, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test;
- Intolerance to tacrolimus, excipients (including lactose, fructose or galactose), or similar products;
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
France7 sites
Sandoz Investigative Site
Grenoble
Sandoz Investigative Site
Limoges
Sandoz Investigative Site
Nantes
Sandoz Investigative Site
Strasbourg
Sandoz Investigative Site
Suresnes
Sandoz Investigative Site
Toulouse
Sandoz Investigative Site
Tours
Germany6 sites
Sandoz Investigative Site
Berlin
Sandoz Investigative Site
Bochum
Sandoz Investigative Site
Essen
Sandoz Investigative Site
Hanover
Sandoz Investigative Site
Kaiserslautern
Sandoz Investigative Site
Kiel
About this study
Official title: Randomized, Multicenter, Open-Label, Two-period, Two-sequence Crossover Comparative Pharmacokinetic Study of Generic Tacrolimus (Sandoz) and Advagraf® in Stable Renal Transplant Patients (TODAY)
Study to compare pharmacokinetics of tacrolimus prolonged-release (PR) capsules and Advagraf® PR capsules in stable kidney transplant patients.
Read the detailed description
Initially, patients will enter a short screening period, and those who continue to meet the inclusion and exclusion criteria will be randomized to receive either test or reference medicinal product in Period 1. In period 2 they will switch to the other formulation. During the whole treatment period four full-pharmacokinetics profiles will be established.
- Conditions
- Kidney Transplant
- Being tested
- Advagraf®, Generic tacrolimus
- Keywords
- Kidney transplant; Renal transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advagraf®Drug
Advagraf®1 mg and 5 mg prolonged-release hard capsules once daily (reference medicinal product).
Generic tacrolimusDrug
Tacrolimus 1 mg and 5 mg prolonged release hard capsules (Sandoz) once daily (test medicinal product)
| Study group | Role | What they receive |
|---|---|---|
| Period 1: Advagraf®; Period 2: Generic tacrolimus | Experimental | In Period 1 patients will receive branded tacrolimus (Advagraf®) orally once-a-day and in Period 2 patients will receive the generic tacrolimus (Sandoz) orally once-a-day. Receives: Drug: Advagraf®; Drug: Generic tacrolimus |
| Period 1: Generic tacrolimus; Period 2: Advagraf® | Experimental | In Period 1 patients will receive the generic tacrolimus (Sandoz) orally once-a-day and in Period 2 patients will receive branded tacrolimus (Advagraf®) orally once-a-day. Receives: Drug: Advagraf®; Drug: Generic tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-τ)ss
Area under the whole blood concentration curve during a dosage interval (τ=24 hours) at steady state
Measured: Day 21 of each treatment period
Cmax,ss
Maximum whole blood concentration at steady state
Measured: Day 21 of each treatment period
Secondary outcomes (10)
AUC(0-τ)ss
Area under the whole blood concentration curve during a dosage interval (τ=24 hours) at steady state
Measured: Day 14 of each treatment period
Cmax,ss
Maximum whole blood concentration at steady state
Measured: Day 14 of each treatment period
Cmin,ss
Minimum whole blood concentration at steady state
Measured: Days 14 and 21 of each treatment period
Cτ,ss
Concentration at the end of the dosing interval at steady state
Measured: Days 14 and 21 of each treatment period
Cav
Average concentration during a dosing interval: AUC(0-τ)/τ
Measured: Days 14 and 21 of each treatment period
Tmax,ss
Time to reach maximum (peak) plasma concentration at steady state
Measured: Days 14 and 21 of each treatment period
AUC(0-τ)ss coefficient of variation
Intra-patient pharmacokinetics variability evaluated by calculating AUC(0-τ)ss coefficient of variation
Measured: Days 14 and 21 of each treatment period
Cmax,ss coefficient of variation
Intra-patient pharmacokinetics variability evaluated by calculating Cmax,ss coefficient of variation
Measured: Days 14 and 21 of each treatment period
% Fluctuation
Degree of fluctuation of the analyte concentration levels over one dosing interval: 100*(Cmax,ss - Cmin,ss)/Cav.
Measured: Days 14 and 21 of each treatment period
%Swing
Degree of change of the analyte concentration levels over one dosing interval: 100*(Cmax,ss - Cτ,ss)/Cτ,ss.
Measured: Days 14 and 21 of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start2 Sep 2019 (estimated)
- Primary completion3 May 2020 (estimated)
- Study completion3 May 2020 (estimated)
Why it stopped: company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandoz, Study director, Sandoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978494
- Sponsor's protocol ID
- 1829-TAC-1
- Other IDs
- 2018-002672-40, 2018
- Acronym
- TODAY
- Status last verified
- Sep 2019
- First submitted
- 5 Jun 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter, Open-Label, Two-period, Two-sequence Crossover Comparative Pharmacokinetic Study of Generic Tacrolimus (Sandoz) and Advagraf® in Stable Renal Transplant Patients (TODAY)
- ClinicalTrials.gov ID
- NCT03978494
- Acronym / sponsor ID
- TODAY / 1829-TAC-1
- Conditions
- Kidney Transplant
- Keywords
- Kidney transplant; Renal transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: company decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2019 (estimated)
- Primary completion
- 3 May 2020 (estimated)
- Study completion
- 3 May 2020 (estimated)
- First posted
- 7 Jun 2019 (actual)
- 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.
Study to compare pharmacokinetics of tacrolimus prolonged-release (PR) capsules and Advagraf® PR capsules in stable kidney transplant patients.
Detailed description
Initially, patients will enter a short screening period, and those who continue to meet the inclusion and exclusion criteria will be randomized to receive either test or reference medicinal product in Period 1. In period 2 they will switch to the other formulation. During the whole treatment period four full-pharmacokinetics profiles will be established.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1: Advagraf®; Period 2: Generic tacrolimus | Experimental | Drug: Advagraf®, Drug: Generic tacrolimusIn Period 1 patients will receive branded tacrolimus (Advagraf®) orally once-a-day and in Period 2 patients will receive the generic tacrolimus (Sandoz) orally once-a-day. |
| Period 1: Generic tacrolimus; Period 2: Advagraf® | Experimental | Drug: Advagraf®, Drug: Generic tacrolimusIn Period 1 patients will receive the generic tacrolimus (Sandoz) orally once-a-day and in Period 2 patients will receive branded tacrolimus (Advagraf®) orally once-a-day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients aged ≥18 years;
- Patients with a Body Mass Index (BMI) included in the interval [18.5-33.0] kg/m²;
- Patients who received a primary kidney transplant at least 12 months prior to study entry
Key exclusion criteria (5 listed)
- Evidence or suspicion of ongoing or persistent, acute or chronic rejection;
- Requirement for dialysis within the six months prior to study entry;
- Glomerular filtration rate (GFR) <30 mL/min
- Pregnant or breastfeeding women, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test;
- Intolerance to tacrolimus, excipients (including lactose, fructose or galactose), or similar products;
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 |
|---|---|---|
| Advagraf®Advagraf®1 mg and 5 mg prolonged-release hard capsules once daily (reference medicinal product). | Drug | Period 1: Advagraf®; Period 2: Generic tacrolimus, Period 1: Generic tacrolimus; Period 2: Advagraf® |
| Generic tacrolimusTacrolimus 1 mg and 5 mg prolonged release hard capsules (Sandoz) once daily (test medicinal product) | Drug | Period 1: Advagraf®; Period 2: Generic tacrolimus, Period 1: Generic tacrolimus; Period 2: Advagraf® |
Primary outcome
AUC(0-τ)ss
Time frame: Day 21 of each treatment period
Area under the whole blood concentration curve during a dosage interval (τ=24 hours) at steady state
Cmax,ss
Time frame: Day 21 of each treatment period
Maximum whole blood concentration at steady state
10 secondary outcomes
AUC(0-τ)ss
Time frame: Day 14 of each treatment period
Cmax,ss
Time frame: Day 14 of each treatment period
Cmin,ss
Time frame: Days 14 and 21 of each treatment period
Cτ,ss
Time frame: Days 14 and 21 of each treatment period
Cav
Time frame: Days 14 and 21 of each treatment period
Tmax,ss
Time frame: Days 14 and 21 of each treatment period
AUC(0-τ)ss coefficient of variation
Time frame: Days 14 and 21 of each treatment period
Cmax,ss coefficient of variation
Time frame: Days 14 and 21 of each treatment period
% Fluctuation
Time frame: Days 14 and 21 of each treatment period
%Swing
Time frame: Days 14 and 21 of each treatment period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Sandoz study director
Sandoz
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Advagraf® and Generic tacrolimus in people with Kidney Transplant, run by Sandoz at 13 sites in 2 countries.
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 5 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: withdrawn, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
AUC(0-τ)ss (time frame: Day 21 of each treatment period). The study lists 2 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 17 Sep 2019.