Kidney DiseasesPhase 4CYRANONCT02311010
Practical Use of Advagraf de Novo After Kidney Transplantation According to Recipient Genetic Polymorphism
A Phase 4 study testing Advagraf in people with Kidney Diseases, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
To optimize the Advagraf (tacrolimus once a day) initial daily dose used in de novo after kidney transplantation in combination with MMF (or MPA) and corticosteroids (CS) regarding of the genetic Cyp 450 3A5 polymorphism of the recipient. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Advagraf
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Jan 2015
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First or second Kidney Transplantation from deceased or living donor
Who cannot join
- Donor age < 5 years.
- Patients who require plasma exchange because of high immunological risk
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaires Saint Luc Université Catholique de Louvain
Brussels, 1200
About this study
Official title: Influence of Recipient Cytochrome P450 3A5 Polymorphism on the Metabolism of Prolonged Release Tacrolimus Administered de Novo After Renal Transplantation
To optimize the Advagraf (tacrolimus once a day) initial daily dose used in de novo after kidney transplantation in combination with MMF (or MPA) and corticosteroids (CS) regarding of the genetic Cyp 450 3A5 polymorphism of the recipient.
The study of the tacrolimus through level (ng/ml) determines if the therapeutic level is reached.
- Conditions
- Kidney Diseases
- Being tested
- Advagraf
- Keywords
- transplant, immunosuppressive drug
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvagrafDrug
Also called Tacrolimus prolonged release formulation
daily dose adapted according to Cyp 3A5 polymorphism
| Study group | Role | What they receive |
|---|---|---|
| CYP 3 A 5 *3/*3 control group | No intervention | CYP 3 A 5 *3/*3 control group will receive 0,20 mg/kg of Advagraf® |
| CYP 3 A 5 *3/*3 | Active comparator | CYP 3 A 5 *3/*3 will receive 0,25 mg/kg of Advagraf® Receives: Drug: Advagraf |
| CYP 3 A 5 *1/*3 | Active comparator | CYP 3 A 5 *1/*3 will receive 0,30 mg/kg of Advagraf® Receives: Drug: Advagraf |
| CYP 3 A 5 *1/*1 | Active comparator | CYP 3 A 5 *1/*1 will receive 0,35 mg/kg of Advagraf® Receives: Drug: Advagraf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of tacrolimus
tacrolimus level (ng/ml) at C0 every 3 days during 2 weeks and thereafter every month during 1 year
Measured: 1 year
Secondary outcomes (1)
Kidney graft function
serum creatinine level (mg/dl) and GFR (ml/min)
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 posted8 Dec 2014 (estimated)
- Study startJan 2011
- Primary completionOct 2014
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Martine De Meyer, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311010
- Sponsor's protocol ID
- BE-02-RG-234
- Other IDs
- 2011-004276-11
- Acronym
- CYRANO
- Status last verified
- Dec 2014
- First submitted
- 21 Aug 2014
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
De Meyer M, Haufroid V, Kanaan N, Darius T, Buemi A, De Pauw L, Eddour DC, Wallemacq P, Mourad M. Pharmacogenetic-based strategy using de novo tacrolimus once daily after kidney transplantation: prospective pilot study. Pharmacogenomics. 2016 Jun;17(9):1019-27. doi: 10.2217/pgs-2016-0005. Epub 2016 Jun 8.
PubMed 27266721
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Recipient Cytochrome P450 3A5 Polymorphism on the Metabolism of Prolonged Release Tacrolimus Administered de Novo After Renal Transplantation
- ClinicalTrials.gov ID
- NCT02311010
- Acronym / sponsor ID
- CYRANO / BE-02-RG-234
- Conditions
- Kidney Diseases
- Keywords
- transplant, immunosuppressive drug
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (estimated)
- First posted
- 8 Dec 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.
To optimize the Advagraf (tacrolimus once a day) initial daily dose used in de novo after kidney transplantation in combination with MMF (or MPA) and corticosteroids (CS) regarding of the genetic Cyp 450 3A5 polymorphism of the recipient.
The study of the tacrolimus through level (ng/ml) determines if the therapeutic level is reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CYP 3 A 5 *3/*3 control group | No intervention | –CYP 3 A 5 *3/*3 control group will receive 0,20 mg/kg of Advagraf® |
| CYP 3 A 5 *3/*3 | Active comparator | Drug: AdvagrafCYP 3 A 5 *3/*3 will receive 0,25 mg/kg of Advagraf® |
| CYP 3 A 5 *1/*3 | Active comparator | Drug: AdvagrafCYP 3 A 5 *1/*3 will receive 0,30 mg/kg of Advagraf® |
| CYP 3 A 5 *1/*1 | Active comparator | Drug: AdvagrafCYP 3 A 5 *1/*1 will receive 0,35 mg/kg of Advagraf® |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- First or second Kidney Transplantation from deceased or living donor
Key exclusion criteria (2 listed)
- Donor age < 5 years.
- Patients who require plasma exchange because of high immunological risk
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 |
|---|---|---|
| AdvagrafAlso: Tacrolimus prolonged release formulationdaily dose adapted according to Cyp 3A5 polymorphism | Drug | CYP 3 A 5 *1/*1, CYP 3 A 5 *1/*3, CYP 3 A 5 *3/*3 |
Primary outcome
Pharmacokinetics of tacrolimus
Time frame: 1 year
tacrolimus level (ng/ml) at C0 every 3 days during 2 weeks and thereafter every month during 1 year
1 secondary outcome
Kidney graft function
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
- Derived from this study: PubMed 27266721De Meyer M, Haufroid V, Kanaan N, Darius T, Buemi A, De Pauw L, Eddour DC, Wallemacq P, Mourad M. Pharmacogenetic-based strategy using de novo tacrolimus once daily after kidney transplantation: prospective pilot study. Pharmacogenomics. 2016 Jun;17(9):1019-27. doi: 10.2217/pgs-2016-0005. Epub 2016 Jun 8.
Related trials for Kidney Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
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.
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 Advagraf in people with Kidney Diseases, run by Université Catholique de Louvain at 1 site in Belgium.
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 1 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: status not confirmed, as of the sponsor's last update on 8 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 Belgium. 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?
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?
Pharmacokinetics of tacrolimus (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02311010, which also lists 1 linked publication.
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 8 Dec 2014.