Renal TransplantationPhase 4AADAPTNCT01435291
AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation
A Phase 4 study testing Advagraf Capsule and Prograf Capsule in people with Renal Transplantation, run by Centre Hospitalier Universitaire de Nice at 4 sites in France.
Trial summary
A pharmacokinetics and pharmacogenetics study to complement the current knowledge of tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at steady-state (M3 post transplantation) and to improve the optimal dose of Advagraf® based on tacrolimus AUC estimated by two Limited Samples… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Advagraf Capsule and Prograf Capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2011to Jul 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult recipients aged between 18 to 70
- Primary renal transplantation
- Cadaver or living transplantation or living (non HLA identical) donor with compatible ABO blood type.
- absence of anti-LHA antibodies in lymphocytotoxicity and Luminex
- Negative cross-match in cytotoxicity
- Negative pregnancy test for female patients of childbearing potential, and agreement to practice effective birth control during the study
Who cannot join
- Combined transplantation
- Renal bigraft
- History of any other transplantation
- Receiving a graft from a non-heart-beating donor.
- Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation
- Patient who received within one month prior to study an inductor of CYP50 3A or requiring during the study an inhibitor of CYP50 3A or of P-gp.
Show all 15Show fewer
- Significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
- Subject or donor known to be HIV positive
- Active viral hepatitis (VHB, VHC) at randomisation
- Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, or mycophenolate mofetil or any of the product excipients
- Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully.
- Current participation in any other clinical study
- Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study
- Patient not able to comply with the study procedures
- Breast-feeding mother
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Bicêtre
Le Kremlin-Bicêtre
CHU de Nice
Nice, 06200
CHU de Rangueil
Toulouse
CHRU Tours Hôpital Bretonneau
Tours
About this study
Official title: Prospective Pharmacokinetic and Pharmacogenetic Analysis of Advagraf After Transplantation
A pharmacokinetics and pharmacogenetics study to complement the current knowledge of tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at steady-state (M3 post transplantation) and to improve the optimal dose of Advagraf® based on tacrolimus AUC estimated by two Limited Samples Strategies during the first 3 months after renal transplantation.
Data obtained with tacrolimus prolonged release will be compared with those of tacrolimus immediate release (Prograf®)
Read the detailed description
Multicentre open-labeled randomized pharmacokinetic (PK) and pharmacogenetic (PG) study to compare Advagraf and Prograf immediate post-transplantation (Day 8) and steady-state (Day 84) systemic exposure.
Tacrolimus PK profile, tacrolimus systemic exposure assessed by Limited Samples Strategies (LSS) (i.e.: Bayesian estimators (BE) and Multilinear Regressions (MLR)), and impact of CYP3A5 and ABCB1 genetic polymorphisms on tacrolimus PK will also be determined to improve the optimal dose of Advagraf® for kidney transplant patients.
- Conditions
- Renal Transplantation
- Being tested
- Advagraf Capsule, Prograf Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advagraf CapsuleDrug
Other Names:
- FK506E
- MR4
- tacrolimus modified/prolonged release Drug: MPA Solution for infusion and per os Other Name: Mycophenolate Mofetil or Mycophenolic Acid Drug: Basiliximab IV infusion Other Name: Simulect Drug: Corticosteroids per os Other Name: Methylprednisolone or equivalent
Prograf CapsuleDrug
Other Names:
- FK506E
- MR4
- tacrolimus Drug: MPA Solution for infusion and per os Other Name: Mycophenolate Mofetil or Mycophenolic Acid Drug: Basiliximab IV infusion Other Name: Simulect Drug: Corticosteroids per os Other Name: Methylprednisolone or equivalent
| Study group | Role | What they receive |
|---|---|---|
| Advagraf | Experimental | Not described Receives: Drug: Advagraf Capsule |
| Prograf | Active comparator | Not described Receives: Drug: Prograf Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-24h of tacrolimus at Day 8 and Day 84
Measured: 3 months
Secondary outcomes (1)
AUC 24h of tacrolimus using limited samples strategies (LSS) at Day 8 and Day 84
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2013
- Study completionJul 2013
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 Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth CASSUTO, PH, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435291
- Sponsor's protocol ID
- 11-PP-07
- Acronym
- AADAPT
- Status last verified
- Mar 2026
- First submitted
- 15 Sep 2011
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Kramer BK, Albano L, Banas B, Charpentier B, Backman L, Tedesco-Silva H Jr, Lehner F, Mondragon-Ramirez GA, Glyda M, Cassuto-Viguier E, Viklicky O, Mourad G, Rigotti P, Schleibner S, Kamar N. Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials. Transplant Proc. 2017 Nov;49(9):2040-2049. doi: 10.1016/j.transproceed.2017.07.011.
PubMed 29149958
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pharmacokinetic and Pharmacogenetic Analysis of Advagraf After Transplantation
- ClinicalTrials.gov ID
- NCT01435291
- Acronym / sponsor ID
- AADAPT / 11-PP-07
- Conditions
- Renal Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Sep 2011 (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.
A pharmacokinetics and pharmacogenetics study to complement the current knowledge of tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at steady-state (M3 post transplantation) and to improve the optimal dose of Advagraf® based on tacrolimus AUC estimated by two Limited Samples Strategies during the first 3 months after renal transplantation.
Data obtained with tacrolimus prolonged release will be compared with those of tacrolimus immediate release (Prograf®)
Detailed description
Multicentre open-labeled randomized pharmacokinetic (PK) and pharmacogenetic (PG) study to compare Advagraf and Prograf immediate post-transplantation (Day 8) and steady-state (Day 84) systemic exposure.
Tacrolimus PK profile, tacrolimus systemic exposure assessed by Limited Samples Strategies (LSS) (i.e.: Bayesian estimators (BE) and Multilinear Regressions (MLR)), and impact of CYP3A5 and ABCB1 genetic polymorphisms on tacrolimus PK will also be determined to improve the optimal dose of Advagraf® for kidney transplant patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advagraf | Experimental | Drug: Advagraf Capsule |
| Prograf | Active comparator | Drug: Prograf Capsule |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult recipients aged between 18 to 70
- Primary renal transplantation
- Cadaver or living transplantation or living (non HLA identical) donor with compatible ABO blood type.
- absence of anti-LHA antibodies in lymphocytotoxicity and Luminex
- Negative cross-match in cytotoxicity
Key exclusion criteria (15 listed)
- Combined transplantation
- Renal bigraft
- History of any other transplantation
- Receiving a graft from a non-heart-beating donor.
- Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation
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 CapsuleOther Names: * FK506E * MR4 * tacrolimus modified/prolonged release Drug: MPA Solution for infusion and per os Other Name: Mycophenolate Mofetil or Mycophenolic Acid Drug: Basiliximab IV infusion Other Name: Simulect Drug: Corticosteroids per os Other Name: Methylprednisolone or equivalent | Drug | Advagraf |
| Prograf CapsuleOther Names: * FK506E * MR4 * tacrolimus Drug: MPA Solution for infusion and per os Other Name: Mycophenolate Mofetil or Mycophenolic Acid Drug: Basiliximab IV infusion Other Name: Simulect Drug: Corticosteroids per os Other Name: Methylprednisolone or equivalent | Drug | Prograf |
Primary outcome
AUC 0-24h of tacrolimus at Day 8 and Day 84
Time frame: 3 months
1 secondary outcome
AUC 24h of tacrolimus using limited samples strategies (LSS) at Day 8 and Day 84
Time frame: 3 months
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 31 Mar 2026.
- Results publication: PubMed 29149958Kramer BK, Albano L, Banas B, Charpentier B, Backman L, Tedesco-Silva H Jr, Lehner F, Mondragon-Ramirez GA, Glyda M, Cassuto-Viguier E, Viklicky O, Mourad G, Rigotti P, Schleibner S, Kamar N. Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials. Transplant Proc. 2017 Nov;49(9):2040-2049. doi: 10.1016/j.transproceed.2017.07.011.
Related trials for Renal Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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.
Elisabeth CASSUTO, PH principal investigator
Centre Hospitalier Universitaire de Nice
4 sites 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 Capsule and Prograf Capsule in people with Renal Transplantation, run by Centre Hospitalier Universitaire de Nice at 4 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 6 inclusion and 15 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 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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?
AUC 0-24h of tacrolimus at Day 8 and Day 84 (time frame: 3 months). 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 NCT01435291, 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 31 Mar 2026.