Kidney Transplant RecipientsPhase 4NCT00199667
Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients
A Phase 4 study testing Mycophenolate Mofetil in people with Kidney Transplant Recipients, run by University Hospital, Limoges at 11 sites in France.
Trial summary
Acumulating data suggest that thrapeutic drug therapeutic may optimize efficacity and tolerance of MMF. It could guarantee better exposure to the drug in the first 3 months and then minimize side effects in the long term. However definitive proof is still lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Recipients
- What is being tested?
- Mycophenolate Mofetil
- How many people
- 137 participants
- Where
- 11 sitesFrance
- Study dates
- Oct 2002to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients received a first or a second kidney transplantation
- patients with panel reactive antibody <or= 50 %
- patients with cellcept treatment since fewer 3 days
- patients receiving or being received ciclosporine treatment
- patients without retention, important hepatic cytolysis
- patients without post-surgical complication or intercurrent disease
- informed consent signed
Who cannot join
- patients included in other study
- patients with MMF or mycophenolic acid hypersensibility or MMF contraindication
- patients with gastroduodenal disorder before the beginning of the study
- pregnant women or without contraception
- patients with rapamycin or analogous
- patients with toxicomania or psychiatric disorder
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Néphrologie
Amiens, 80000
Néphrologie
Angers, 49000
Néphrologie
Caen, 14000
Néphrologie
Limoges, 87042
Néphrologie
Paris, 75000
Néphrologie
Poitiers, 86000
Néphrologie
Reims, 51000
Néphrologie
Rouen, 76000
Néphrologie
Strasbourg, 67000
Néphrologie
Toulouse, 31059
Néphrologie
Tours, 37000
About this study
Official title: APOMYGRE : Multicenter, Randomized, Open-Label Study of MMF Therapeutic Follow-up's Interest in the the 12 First Months in Kidney Transplantation
Acumulating data suggest that thrapeutic drug therapeutic may optimize efficacity and tolerance of MMF. It could guarantee better exposure to the drug in the first 3 months and then minimize side effects in the long term. However definitive proof is still lacking. We conducted a randomized study in 11 french centers and included 137 kidney transplant recipients (PRA<50%) receiving a classical immunosuppressant regimen with basiliximab, Csa, MMF and steroids. The "fixed dose" group received 2 g of MMF a day. The "concentration controlled" group received MMF dose adapted to the area under the concentration curve (AUC) of MPA, with a target of 40 h.mg/L. After transplantation AUCs were calculated with a Bayesian estimator using a 3-point limited sampling strategy on day 7, 14, and months 1, 3, 6 , 12 in both groups (values note communicated to the physicians in the "fixed dose" group.
- Conditions
- Kidney Transplant Recipients
- Being tested
- Mycophenolate Mofetil
- Keywords
- MMF, Monitoring, area under curve (AUC), kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
immunosuppressant treatment fealure (kidney rejection, adverse events, death, graft lost).
Secondary outcomes (1)
renal fonction evolution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- 137 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Yann LE MEUR, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199667
- Sponsor's protocol ID
- I02013
- Status last verified
- Dec 2008
- First submitted
- 14 Sep 2005
- Last updated
- 16 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APOMYGRE : Multicenter, Randomized, Open-Label Study of MMF Therapeutic Follow-up's Interest in the the 12 First Months in Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00199667
- Acronym / sponsor ID
- I02013
- Conditions
- Kidney Transplant Recipients
- Keywords
- MMF, Monitoring, area under curve (AUC), kidney transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 137 participants
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Oct 2002
- First posted
- 20 Sep 2005 (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.
Acumulating data suggest that thrapeutic drug therapeutic may optimize efficacity and tolerance of MMF. It could guarantee better exposure to the drug in the first 3 months and then minimize side effects in the long term. However definitive proof is still lacking. We conducted a randomized study in 11 french centers and included 137 kidney transplant recipients (PRA<50%) receiving a classical immunosuppressant regimen with basiliximab, Csa, MMF and steroids. The "fixed dose" group received 2 g of MMF a day. The "concentration controlled" group received MMF dose adapted to the area under the concentration curve (AUC) of MPA, with a target of 40 h.mg/L. After transplantation AUCs were calculated with a Bayesian estimator using a 3-point limited sampling strategy on day 7, 14, and months 1, 3, 6 , 12 in both groups (values note communicated to the physicians in the "fixed dose" group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients received a first or a second kidney transplantation
- patients with panel reactive antibody <or= 50 %
- patients with cellcept treatment since fewer 3 days
- patients receiving or being received ciclosporine treatment
- patients without retention, important hepatic cytolysis
Key exclusion criteria (6 listed)
- patients included in other study
- patients with MMF or mycophenolic acid hypersensibility or MMF contraindication
- patients with gastroduodenal disorder before the beginning of the study
- pregnant women or without contraception
- patients with rapamycin or analogous
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 |
|---|---|---|
| Mycophenolate Mofetil | Drug | – |
Primary outcome
immunosuppressant treatment fealure (kidney rejection, adverse events, death, graft lost).
1 secondary outcome
renal fonction evolution
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2008.
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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.
Yann LE MEUR, MD principal investigator
University Hospital, Limoges
11 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 Mycophenolate Mofetil in people with Kidney Transplant Recipients, run by University Hospital, Limoges at 11 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 7 inclusion and 6 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 16 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
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?
immunosuppressant treatment fealure (kidney rejection, adverse events, death, graft lost).. 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 16 Dec 2008.