Kidney TransplantationPhase 4NCT00817687
A Study of the Impact of an Early Biopsy in Patients Treated With CellCept (Mycophenolate Mofetil) After Kidney Transplantation
A Phase 4 study testing mycophenolate mofetil [CellCept] in people with Kidney Transplantation, run by Hoffmann-La Roche at 17 sites in France.
Trial summary
This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in patients who have received a kidney transplant from an expanded criteria donor. Patients will be randomized to one of two groups; the first group will have a biopsy at day 10, and the second group will receive standard management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- mycophenolate mofetil [CellCept]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 17 sitesFrance
- Study dates
- Jan 2009to Jan 2012
- 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
- adult patients, >=18 years of age;
- in receipt of an initial cadaveric kidney transplant;
- in receipt of graft with biopsy;
- in receipt of a 'marginal' kidney transplant.
Who cannot join
- in receipt of a second kidney transplant;
- in receipt of a multi-organ transplant or a double kidney transplant;
- malignant tumor, or a history of cancer in past 5 years, other than successfully treated basal cell or spinocellular cancer or cancer in situ of cervix;
- replicating hepatitis B and/or C, or HIV positive serology.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Study site
Besançon, 25030
Study site
Bordeaux, 33076
Study site
Caen, 14033
Study site
Clermont-Ferrand, 63000
Study site
Lille, 59037
Study site
Limoges, 87042
Study site
Marseille, 13385
Study site
Nantes, 44035
Study site
Paris, 75743
Study site
Paris, 75908
Study site
Poitiers, 86021
Study site
Rouen, 76031
Study site
Salouël, 80480
Study site
Strasbourg, 67091
Study site
Suresnes, 92151
Study site
Tours, 37044
Study site
Vandœuvre-lès-Nancy, 54511
About this study
Official title: A Randomised, Multicenter, Open-label Study Evaluating the Impact on the Fibrosis at Week 52 of an Early Biopsy at (D10) Versus Standard Management in Patients Who Have Undergone de Novo Renal Transplantation and Received a Marginal Organ Transplant
This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in patients who have received a kidney transplant from an expanded criteria donor. Patients will be randomized to one of two groups; the first group will have a biopsy at day 10, and the second group will receive standard management. All patients will be given CellCept as standard of care. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
- Conditions
- Kidney Transplantation
- Being tested
- mycophenolate mofetil [CellCept]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mycophenolate mofetil [CellCept]Drug
As prescribed; + early biopsy
mycophenolate mofetil [CellCept]Drug
As prescribed; + standard treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: mycophenolate mofetil [CellCept] |
| 2 | No intervention | Not described Receives: Drug: mycophenolate mofetil [CellCept] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with >=25% increase in fibrosis score
Measured: Day 0 to Week 52
Secondary outcomes (3)
Renal function (creatinine clearance)
Measured: From randomization to Week 52
Incidence and time of occurrence of clinical acute rejection
Measured: From randomization to Week 52
Adverse events, laboratory parameters, cancers and lymphoproliferative syndromes
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817687
- Sponsor's protocol ID
- ML21655
- Status last verified
- Jul 2012
- First submitted
- 16 Dec 2008
- Last updated
- 9 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Multicenter, Open-label Study Evaluating the Impact on the Fibrosis at Week 52 of an Early Biopsy at (D10) Versus Standard Management in Patients Who Have Undergone de Novo Renal Transplantation and Received a Marginal Organ Transplant
- ClinicalTrials.gov ID
- NCT00817687
- Acronym / sponsor ID
- ML21655
- Conditions
- Kidney Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 6 Jan 2009 (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.
This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in patients who have received a kidney transplant from an expanded criteria donor. Patients will be randomized to one of two groups; the first group will have a biopsy at day 10, and the second group will receive standard management. All patients will be given CellCept as standard of care. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: mycophenolate mofetil [CellCept] |
| 2 | No intervention | Drug: mycophenolate mofetil [CellCept] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients, >=18 years of age;
- in receipt of an initial cadaveric kidney transplant;
- in receipt of graft with biopsy;
- in receipt of a 'marginal' kidney transplant.
Key exclusion criteria (4 listed)
- in receipt of a second kidney transplant;
- in receipt of a multi-organ transplant or a double kidney transplant;
- malignant tumor, or a history of cancer in past 5 years, other than successfully treated basal cell or spinocellular cancer or cancer in situ of cervix;
- replicating hepatitis B and/or C, or HIV positive serology.
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 [CellCept]As prescribed; + early biopsy | Drug | 1 |
| mycophenolate mofetil [CellCept]As prescribed; + standard treatment | Drug | 2 |
Primary outcome
Proportion of patients with >=25% increase in fibrosis score
Time frame: Day 0 to Week 52
3 secondary outcomes
Renal function (creatinine clearance)
Time frame: From randomization to Week 52
Incidence and time of occurrence of clinical acute rejection
Time frame: From randomization to Week 52
Adverse events, laboratory parameters, cancers and lymphoproliferative syndromes
Time frame: Throughout study
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 9 Jul 2012.
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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.
Clinical Trials study director
Hoffmann-La Roche
17 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 [CellCept] in people with Kidney Transplantation, run by Hoffmann-La Roche at 17 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: finished, as of the sponsor's last update on 9 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Proportion of patients with >=25% increase in fibrosis score (time frame: Day 0 to Week 52). 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 9 Jul 2012.