Kidney TransplantNCT03228576
Prospective Cohort of Kidney Transplanted Patients Receiving an Extended Releasing Tacrolimus-Everolimus Association
An observational study of Kidney Transplant and Immunosuppression, run by Poitiers University Hospital at 9 sites in France.
Trial summary
The tacrolimus-Everolimus association is used as an immunospressive treatment after a kidney transplant. It combined immunosupressive properties of both products and reduce the nephrotoxicity of tacrolimus by lowering the dosage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Immunosuppression
- What is being tested?
- Extended release Tacrolimus-Everolimus association
- How many people
- 16 participants
- Where
- 9 sitesFrance
- Study dates
- 14 Apr 2017to 18 Dec 2018
- 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: Patients over 18 years old with kidney transplantation for at least one year.
Who may be able to join
- Patients over 18 years old
- Patients informed and giving his agreement to the use of every collected data
- Patients with kidney transplantation for at least one year and being treated with the immunosppressive assiociation of Tacrolimus (Prograf ®)-Everolimus
- Patients whose investigators decides to switch from Prograf ® to an Envarsus ®-Everolimus association
Who cannot join
- Other transplantation
- Drug or alcohol abuse
- Patients unable to understand the purpose or modalities of this study, unable to give his agreement or unable to stick to the protocol
- Patients on an interventionnal protocol when included
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Amiens University Hospital
Amiens, 80000
Angers University Hospital
Angers, 49100
Caen University Hospital
Caen, 14033
Clermont Ferrand University Hospital
Clermont-Ferrand, 63000
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86000
Rennes University Hospital
Rennes, 35000
Rouen University Hospital
Rouen, 76000
Strasbourg University Hospital
Strasbourg, 67000
Tours University Hospital
Tours, 37000
About this study
Official title: Observationnal Multicenter Study on a Prospective Cohort of Kidney Transplanted Patients Receiving a Year After Transplant an Extended Releasing Tacrolimus-Everolimus Association
The tacrolimus-Everolimus association is used as an immunospressive treatment after a kidney transplant. It combined immunosupressive properties of both products and reduce the nephrotoxicity of tacrolimus by lowering the dosage.
The commercialisation of a new extended release Tacrolimus pharmaceutical form and the lack of information justify a modality of use and tolerence evaluation of this new association, commonly used.
- Conditions
- Kidney Transplant, Immunosuppression
- Being tested
- Extended release Tacrolimus-Everolimus association
- Keywords
- Tacrolimus, Envarsus, Everolimus, kidney, Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended release Tacrolimus-Everolimus associationCombination product
Envarsus® will be used as Tacrolimus Certican® will be used as Everolimus
| Study group | Role | What they receive |
|---|---|---|
| TREVISE | Not described Receives: Combination Product: Extended release Tacrolimus-Everolimus association |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of the Certican®-Envarsus® association
Assess clinical and biological tolerance of the Certican®-Envarsus® association on kidney transplanted patient, one year after transplant : study of adverse events with biological results (biochimy, hematology).
Study of incidence of Treatment-Emergent Adverse Events.
Measured: During 1 year, between each visit (J0, M3, M6, M9, M12)
Secondary outcomes (6)
Patients description
Describe the profil of included patients
Measured: 1 year
clinical evolution
Describe the patients clinical evolution after a one year follow up : adverse events, renal function (creatinine)...
Measured: 1 year
Treatment
Describe treatments and switch modalities : tolerability with adverse events, conversion value between Prograf® and Envarsus®
Measured: 1 year
Renal function
Describe the evolution of renal function during follow up : creatinine value during the study
Measured: 1 year
Graft Rejections and survival rates
Assess acute graft rejections (confirmed by a biopsy with the Banff classification and creatinine value) and transplants survival rates a year after the switch : all renal biopsies will be reported, with the reason for the biopsy.
Measured: 1 year
Medication compliance
Assess medication compliance during the switch and by the end of the study, to evaluated by doctor by asking the patient and with pharmacological concentrations (used in nephrology)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start14 Apr 2017
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Why it stopped: No recruitment
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.
- More trials run by Poitiers University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228576
- Sponsor's protocol ID
- TREVISE
- Status last verified
- Aug 2019
- First submitted
- 23 Jun 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observationnal Multicenter Study on a Prospective Cohort of Kidney Transplanted Patients Receiving a Year After Transplant an Extended Releasing Tacrolimus-Everolimus Association
- ClinicalTrials.gov ID
- NCT03228576
- Acronym / sponsor ID
- TREVISE
- Conditions
- Kidney Transplant, Immunosuppression
- Keywords
- Tacrolimus, Envarsus, Everolimus, kidney, Transplant
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No recruitment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Study start
- 14 Apr 2017 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 25 Jul 2017 (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.
The tacrolimus-Everolimus association is used as an immunospressive treatment after a kidney transplant. It combined immunosupressive properties of both products and reduce the nephrotoxicity of tacrolimus by lowering the dosage.
The commercialisation of a new extended release Tacrolimus pharmaceutical form and the lack of information justify a modality of use and tolerence evaluation of this new association, commonly used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TREVISE | – | Combination Product: Extended release Tacrolimus-Everolimus association |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years old with kidney transplantation for at least one year.
Key inclusion criteria (4 listed)
- Patients over 18 years old
- Patients informed and giving his agreement to the use of every collected data
- Patients with kidney transplantation for at least one year and being treated with the immunosppressive assiociation of Tacrolimus (Prograf ®)-Everolimus
- Patients whose investigators decides to switch from Prograf ® to an Envarsus ®-Everolimus association
Key exclusion criteria (4 listed)
- Other transplantation
- Drug or alcohol abuse
- Patients unable to understand the purpose or modalities of this study, unable to give his agreement or unable to stick to the protocol
- Patients on an interventionnal protocol when included
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 |
|---|---|---|
| Extended release Tacrolimus-Everolimus associationEnvarsus® will be used as Tacrolimus Certican® will be used as Everolimus | Combination product | TREVISE |
Primary outcome
Tolerance of the Certican®-Envarsus® association
Time frame: During 1 year, between each visit (J0, M3, M6, M9, M12)
Assess clinical and biological tolerance of the Certican®-Envarsus® association on kidney transplanted patient, one year after transplant : study of adverse events with biological results (biochimy, hematology). Study of incidence of Treatment-Emergent Adverse Events.
6 secondary outcomes
Patients description
Time frame: 1 year
clinical evolution
Time frame: 1 year
Treatment
Time frame: 1 year
Renal function
Time frame: 1 year
Graft Rejections and survival rates
Time frame: 1 year
Medication compliance
Time frame: 1 year
Results and safety
The study was stopped early (reason given: No recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant and Immunosuppression, run by Poitiers University Hospital at 9 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 was stopped early (reason given: No recruitment). Results are not available in the source record.
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?
Tolerance of the Certican®-Envarsus® association (time frame: During 1 year, between each visit (J0, M3, M6, M9, M12)). 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 28 Aug 2019.