Kidney TransplantationPhase 4NCT00217152
A Kidney Transplant Study to Look at the Effects of Taking Fixed Doses of CellCept Versus Taking Doses of CellCept Based on the Concentration of CellCept in the Blood When Taking Full or Reduced Dose Calcineurin Inhibitors
A Phase 4 study testing CellCept in people with Kidney Transplantation and Delayed Graft Function, run by Mayo Clinic at 1 site in United States.
Trial summary
This research is being done to study the effects (good and bad) of taking CellCept based on blood concentrations versus taking a fixed dose of CellCept without measuring the blood concentration. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplantation, Delayed Graft Function
- What is being tested?
- CellCept
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Aug 2007
- 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
- Participants must be between 18 and 70 years of age and should be receiving their first or second kidney transplant.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Prospective, Randomized, Controlled, Multicenter Study Assessing Fixed Dose vs. Concentration Controlled CellCept Regimens for Patients Following a Single Organ Renal Transplantation in Combination With Full Dose and Reduced Dose Calcineurin Inhibitors
This research is being done to study the effects (good and bad) of taking CellCept based on blood concentrations versus taking a fixed dose of CellCept without measuring the blood concentration. CellCept is one of the three immunosuppressant drugs (drugs that suppress the immune system) which will be taken as part of this kidney transplant study. Cyclosporine or tacrolimus and corticosteroids are the two other drugs which will be taken.
Read the detailed description
This study is an open label study, which means the participant will know which drugs they are on. Participants will be put in one of three groups within 24 hours of the participant's transplant. The participant will be asked to return throughout the 24 months for physical exams, blood and urine tests.
- Conditions
- Kidney Transplantation, Delayed Graft Function
- Being tested
- CellCept
- Keywords
- Kidney Transplant
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellCeptDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up
Measured: during the first 12 months following randomization
Assessment of renal function
Measured: 12 months post randomization
Secondary outcomes (5)
The proportion of patients experiencing biopsy proven acute rejections
The total number of biopsy proven, acute rejection episodes, per patient
The proportion of patients treated for acute rejection
The time to the first proven acute rejection
The time to the treatment failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionAug 2007
- Study completionAug 2007
Why it stopped: Roche decided to prematurely terminate study.
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 Mayo ClinicThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Mark D. Stegall, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217152
- Sponsor's protocol ID
- 112-05
- Status last verified
- Dec 2011
- First submitted
- 20 Sep 2005
- Last updated
- 19 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Prospective, Randomized, Controlled, Multicenter Study Assessing Fixed Dose vs. Concentration Controlled CellCept Regimens for Patients Following a Single Organ Renal Transplantation in Combination With Full Dose and Reduced Dose Calcineurin Inhibitors
- ClinicalTrials.gov ID
- NCT00217152
- Acronym / sponsor ID
- 112-05
- Conditions
- Kidney Transplantation, Delayed Graft Function
- Keywords
- Kidney Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Roche decided to prematurely terminate study.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Mar 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 22 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.
This research is being done to study the effects (good and bad) of taking CellCept based on blood concentrations versus taking a fixed dose of CellCept without measuring the blood concentration. CellCept is one of the three immunosuppressant drugs (drugs that suppress the immune system) which will be taken as part of this kidney transplant study. Cyclosporine or tacrolimus and corticosteroids are the two other drugs which will be taken.
Detailed description
This study is an open label study, which means the participant will know which drugs they are on. Participants will be put in one of three groups within 24 hours of the participant's transplant. The participant will be asked to return throughout the 24 months for physical exams, blood and urine tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must be between 18 and 70 years of age and should be receiving their first or second kidney transplant.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CellCept | Drug | – |
Primary outcome
Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up
Time frame: during the first 12 months following randomization
Assessment of renal function
Time frame: 12 months post randomization
5 secondary outcomes
The proportion of patients experiencing biopsy proven acute rejections
The total number of biopsy proven, acute rejection episodes, per patient
The proportion of patients treated for acute rejection
The time to the first proven acute rejection
The time to the treatment failure
Results and safety
The study was stopped early (reason given: Roche decided to prematurely terminate study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2011.
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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.
Mark D. Stegall, M.D. principal investigator
Mayo Clinic
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 CellCept in people with Kidney Transplantation and Delayed Graft Function, run by Mayo Clinic at 1 site 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 0 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: stopped early, as of the sponsor's last update on 19 Dec 2011. 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 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 was stopped early (reason given: Roche decided to prematurely terminate 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?
Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up (time frame: during the first 12 months following randomization). The study lists 2 primary outcomes in all. 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 19 Dec 2011.