Renal TransplantationOPALENCT02147938
A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)
An observational study of Renal Transplantation, run by Astellas Pharma S.A.S. at 26 sites in France.
Trial summary
Assessment in a real situation of the conversion conditions, the efficacy and the safety of the treatment with tacrolimus in renal transplant patients converted from the tacrolimus twice per day form (Prograf®) to the tacrolimus once per day form (Advagraf®) with follow-up at one year. 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?
- Tacrolimus
- Type of treatment
- Pill or oral medicine
- How many people
- 578 participants
- Where
- 26 sitesFrance
- Study dates
- 17 Jul 2014to 15 May 2017
- 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: Renal transplant patients
Who may be able to join
- Renal transplant patient for less than one year
- Patient where the conversion from Prograf® to Advagraf® has been decided by the doctor
Who cannot join
- Patient participating in an interventional clinical trial at the time of inclusion
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
Site
Amiens
Site
Angers
Site
Besançon
Site
Brest
Site
Caen
Site
Clermond-Ferrand
Site
Créteil
Site
Dijon
Site
Le Krémlin-Bicêtre
Site
Lille
Site
Limoges
Site
Lyon 03
Site
Marseille
Site
Montpellier
Site
Nancy
Site
Nantes
Site
Nice
Site
Paris
Site
Poitiers
Site
Rennes
Site
Rouen
Site
Saint-Etienne
Site
Strasbourg
Site
Suresnes
Site
Toulouse
Site
Tours
About this study
Official title: French Multicentre Observational Study of a Prospective Cohort of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)
Assessment in a real situation of the conversion conditions, the efficacy and the safety of the treatment with tacrolimus in renal transplant patients converted from the tacrolimus twice per day form (Prograf®) to the tacrolimus once per day form (Advagraf®) with follow-up at one year.
Analysis of two groups of patients: patients converted from Prograf® to Advagraf® early (during the first 6 months post-transplantation) or late (between 6 and 12 months post-transplantation).
- Conditions
- Renal Transplantation
- Being tested
- Tacrolimus
- Keywords
- France, Tacrolimus, Prograf, Observational, Advagraf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Advagraf®, Prograf®, FK506
oral
| Study group | Role | What they receive |
|---|---|---|
| 1: early conversion from Prograf® to Advagraf® | patients converted during the first 6 months post-transplantation Receives: Drug: Tacrolimus | |
| 2: late conversion from Prograf® to Advagraf® | patients converted between 6 and 12 months post-transplantation Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tacrolimus daily dose conversion ratio (mg Prograf® / mg Advagraf®)
Percentage of patients with a tacrolimus dose conversion ratio of 1mg / 1mg and percentage of patients with a ratio ≠ 1mg / 1mg
Measured: At baseline (i.e. time of conversion)
Time to measurement of the first trough tacrolimus blood concentration (C0) after conversion
number of days between the date of conversion and the date of first assay of C0 after conversion
Measured: From baseline (conversion) to first determination of C0 assessed up to one year
Number of additional visits that the doctor considers to be due to the conversion (if applicable)
percentage of patients with additional visit(s) and percentage of patients without additional visit
Measured: At 6 months and at 1 year follow-up visit
Secondary outcomes (10)
Reasons for the conversion
number of capsules, poor treatment compliance, requested by patient, safety, centre practice, other
Measured: At baseline
Profile of the patients in both groups
sociodemographic data, transplantation history, comorbidities, post-transplantation complications, risk factors and concomitant treatments (Immunosuppressive protocols (IS) and others) at the time of conversion and changes, if applicable, at 6 months and 1 year post-conversion
Measured: At baseline
Time to reach steady state
Measured: Time from baseline (conversion) to steady state C0 assessed up to one year
Dose ratio at steady state
calculation of the tacrolimus daily dose ratio once the steady state is reached: mg Prograf® at conversion / mg Advagraf® once the steady state is reached. Percentage of patients with a ratio of 1mg / 1mg and percentage of patients with a ratio ≠ 1mg / 1mg.
Measured: At baseline (conversion) and up to 6 months post-baseline
The intra-patient variability (IPV) of tacrolimus
Measured: At baseline and up to 6 months post-baseline
Latest available laboratory data with Prograf® before conversion and with Advagraf®
Values and dates for blood and urine renal parameters, blood glucose
Measured: At baseline, 6 months and 1 year follow-up visit
Compliance with the treatment at conversion and at 1 year post-conversion
Compliance with the treatment at conversion (taking Prograf®) and at 1 year post-conversion (taking Advagraf®) only in group 2 (late conversion) will be assessed using the Morisky questionnaire, from which a score will be calculated
Measured: At baseline and 1 year follow-up visit
The quality of life of the patient at conversion and at 1 year post-conversion
The quality of life of the patient at conversion (taking Prograf®) and at 1 year post-conversion (taking Advagraf®) only in group 2 (late conversion) will be assessed using the EQ5D-5L questionnaire
Measured: At baseline and 1 year follow-up visit
Incidence of biopsy proven acute rejections (BPAR) and survival of the graft and of the patient
Measured: At 1 year follow-up visit
Occurrence of adverse effects
Measured: From baseline until 1 year follow-up visit after baseline (conversion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study start17 Jul 2014
- Primary completion15 May 2017
- Study completion15 May 2017
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical and Scientific Affairs Manager, Transplantation, Study director, Astellas Pharma S.A.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147938
- Sponsor's protocol ID
- FR-ADV-NI-003
- Acronym
- OPALE
- Status last verified
- Oct 2024
- First submitted
- 15 May 2014
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Multicentre Observational Study of a Prospective Cohort of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)
- ClinicalTrials.gov ID
- NCT02147938
- Acronym / sponsor ID
- OPALE / FR-ADV-NI-003
- Conditions
- Renal Transplantation
- Keywords
- France, Tacrolimus, Prograf, Observational, Advagraf
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- Astellas Pharma S.A.S.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2014 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 28 May 2014 (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.
Assessment in a real situation of the conversion conditions, the efficacy and the safety of the treatment with tacrolimus in renal transplant patients converted from the tacrolimus twice per day form (Prograf®) to the tacrolimus once per day form (Advagraf®) with follow-up at one year.
Analysis of two groups of patients: patients converted from Prograf® to Advagraf® early (during the first 6 months post-transplantation) or late (between 6 and 12 months post-transplantation).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: early conversion from Prograf® to Advagraf® | – | Drug: Tacrolimuspatients converted during the first 6 months post-transplantation |
| 2: late conversion from Prograf® to Advagraf® | – | Drug: Tacrolimuspatients converted between 6 and 12 months post-transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal transplant patients
Key inclusion criteria (2 listed)
- Renal transplant patient for less than one year
- Patient where the conversion from Prograf® to Advagraf® has been decided by the doctor
Key exclusion criteria (1 listed)
- Patient participating in an interventional clinical trial at the time of inclusion
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: Advagraf®, Prograf®, FK506oral | Drug | 1: early conversion from Prograf® to Advagraf®, 2: late conversion from Prograf® to Advagraf® |
Primary outcome
Tacrolimus daily dose conversion ratio (mg Prograf® / mg Advagraf®)
Time frame: At baseline (i.e. time of conversion)
Percentage of patients with a tacrolimus dose conversion ratio of 1mg / 1mg and percentage of patients with a ratio ≠ 1mg / 1mg
Time to measurement of the first trough tacrolimus blood concentration (C0) after conversion
Time frame: From baseline (conversion) to first determination of C0 assessed up to one year
number of days between the date of conversion and the date of first assay of C0 after conversion
Number of additional visits that the doctor considers to be due to the conversion (if applicable)
Time frame: At 6 months and at 1 year follow-up visit
percentage of patients with additional visit(s) and percentage of patients without additional visit
10 secondary outcomes
Reasons for the conversion
Time frame: At baseline
Profile of the patients in both groups
Time frame: At baseline
Time to reach steady state
Time frame: Time from baseline (conversion) to steady state C0 assessed up to one year
Dose ratio at steady state
Time frame: At baseline (conversion) and up to 6 months post-baseline
The intra-patient variability (IPV) of tacrolimus
Time frame: At baseline and up to 6 months post-baseline
Latest available laboratory data with Prograf® before conversion and with Advagraf®
Time frame: At baseline, 6 months and 1 year follow-up visit
Compliance with the treatment at conversion and at 1 year post-conversion
Time frame: At baseline and 1 year follow-up visit
The quality of life of the patient at conversion and at 1 year post-conversion
Time frame: At baseline and 1 year follow-up visit
Incidence of biopsy proven acute rejections (BPAR) and survival of the graft and of the patient
Time frame: At 1 year follow-up visit
Occurrence of adverse effects
Time frame: From baseline until 1 year follow-up visit after baseline (conversion)
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 1 Nov 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Medical and Scientific Affairs Manager, Transplantation study director
Astellas Pharma S.A.S.
26 sites 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 Astellas Pharma S.A.S. at 26 sites in France.
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 2 inclusion and 1 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. 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?
Tacrolimus daily dose conversion ratio (mg Prograf® / mg Advagraf®) (time frame: At baseline (i.e. time of conversion)). 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 1 Nov 2024.