Kidney TransplantationPhase 4NCT00337493
Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
A Phase 4 study testing mycophenolate mofetil [CellCept] and Cyclosporine or tacrolimus in people with Kidney Transplantation, run by Hoffmann-La Roche at 20 sites in United States.
Trial summary
This study will determine which, if any, allelic variants of mycophenolic acid (MPA) metabolizing enzymes, drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage. Read more about this study
- Who is it for?
- Ages 13 to 75 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- mycophenolate mofetil [CellCept] and Cyclosporine or tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 20 sitesUnited States
- Study dates
- Dec 2005to Jan 2008
- 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 13 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients participating in study ML17225.
Who cannot join
- N/A.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Study site
Augusta, Georgia, 30912
Study site
Birmingham, Alabama, 35294
Study site
Boston, Massachusetts, 02111
Study site
Buffalo, New York, 14203
Study site
Chapel Hill, North Carolina, 27599
Study site
Chicago, Illinois, 60637
Study site
Denver, Colorado, 80262
Study site
Fargo, North Dakota, 58122
Study site
Gainesville, Florida, 32610-0224
Study site
Hackensack, New Jersey, 07601
Study site
Indianapolis, Indiana, 46202-5167
Study site
Lexington, Kentucky, 40536-0293
Study site
Little Rock, Arkansas, 72205-7199
Study site
Livingston, New Jersey, 07039
Study site
Los Angeles, California, 90057
Study site
Madison, Wisconsin, 53792
Study site
Orlando, Florida, 32804
Study site
Philadelphia, Pennsylvania, 19104
Study site
Portland, Oregon, 97210
Study site
Shreveport, Louisiana, 71130
About this study
Official title: A Study to Investigate the Impact of Pharmacogenetics on CellCept Use, in Patients Participating in a Study in Renal Transplantation
This study will determine which, if any, allelic variants of mycophenolic acid (MPA) metabolizing enzymes, drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage. Patients participating in study ML17225 will be eligible for this pharmacogenetic investigation, and will have one additional blood sample taken during the study. The anticipated time on study treatment in study ML17225 is 1-2 years, and the target sample size is 500+ individuals.
- Conditions
- Kidney Transplantation
- Being tested
- mycophenolate mofetil [CellCept], Cyclosporine or tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mycophenolate mofetil [CellCept]Drug
Concentration-controlled
mycophenolate mofetil [CellCept]Drug
1g po bid
Cyclosporine or tacrolimusDrug
Reduced
Cyclosporine or tacrolimusDrug
Standard, as prescribed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: mycophenolate mofetil [CellCept]; Drug: Cyclosporine or tacrolimus |
| 2 | Experimental | Not described Receives: Drug: mycophenolate mofetil [CellCept]; Drug: Cyclosporine or tacrolimus |
| 3 | Experimental | Not described Receives: Drug: mycophenolate mofetil [CellCept]; Drug: Cyclosporine or tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of allelic variants of MPA metabolizing genes, membrane transporter genes and target genes with AUC, transplant rejection, GER and drug side effects.
Measured: Throughout study
Secondary outcomes (1)
Viral kinetics
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 posted16 Jun 2006 (estimated)
- Study startDec 2005
- Primary completionJan 2008
- Study completionJan 2008
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
- 155 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
- NCT00337493
- Sponsor's protocol ID
- ML19199
- Status last verified
- Sep 2012
- First submitted
- 15 Jun 2006
- Last updated
- 17 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Impact of Pharmacogenetics on CellCept Use, in Patients Participating in a Study in Renal Transplantation
- ClinicalTrials.gov ID
- NCT00337493
- Acronym / sponsor ID
- ML19199
- Conditions
- Kidney Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 16 Jun 2006 (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 study will determine which, if any, allelic variants of mycophenolic acid (MPA) metabolizing enzymes, drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage. Patients participating in study ML17225 will be eligible for this pharmacogenetic investigation, and will have one additional blood sample taken during the study. The anticipated time on study treatment in study ML17225 is 1-2 years, and the target sample size is 500+ individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: mycophenolate mofetil [CellCept], Drug: Cyclosporine or tacrolimus |
| 2 | Experimental | Drug: mycophenolate mofetil [CellCept], Drug: Cyclosporine or tacrolimus |
| 3 | Experimental | Drug: mycophenolate mofetil [CellCept], Drug: Cyclosporine or tacrolimus |
Who may qualify
- Ages
- 13 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients participating in study ML17225.
Key exclusion criteria (1 listed)
- N/A.
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]Concentration-controlled | Drug | 1, 2 |
| mycophenolate mofetil [CellCept]1g po bid | Drug | 3 |
| Cyclosporine or tacrolimusReduced | Drug | 1 |
| Cyclosporine or tacrolimusStandard, as prescribed | Drug | 2, 3 |
Primary outcome
Correlation of allelic variants of MPA metabolizing genes, membrane transporter genes and target genes with AUC, transplant rejection, GER and drug side effects.
Time frame: Throughout study
1 secondary outcome
Viral kinetics
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 17 Sep 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
20 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] and Cyclosporine or tacrolimus in people with Kidney Transplantation, run by Hoffmann-La Roche at 20 sites in United States.
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 1 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 17 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. 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?
Correlation of allelic variants of MPA metabolizing genes, membrane transporter genes and target genes with AUC, transplant rejection, GER and drug side effects. (time frame: Throughout study). 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 17 Sep 2012.