Kidney TransplantationPhase 3NCT00788567
CLEAR Study - A Study of CellCept (Mycophenolate Mofetil) in Recipients of Kidney Transplants
A Phase 3 study testing mycophenolate mofetil in people with Kidney Transplantation, run by Hoffmann-La Roche at 9 sites in Canada.
Trial summary
This study will compare the efficacy and safety of 2 dosing regimens of oral CellCept administered as a component of standard immunosuppressive therapy in recipients of kidney transplants. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 9 sitesCanada
- Study dates
- Jun 2005to May 2008
- Phase
- Phase 3
- 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;
- recipients of a primary kidney transplant.
Who cannot join
- positive for HIV-1, human T-cell leukemia/lymphoma virus-1 (HTLV-1), or hepatitis B surface antigen;
- positive for hepatitis C virus, with moderate or severe liver disease;
- active malignancy or history of malignancy, excluding skin cancer (basal or squamous cell) that has been adequately treated;
- need for maintenance corticosteroids for another condition.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Study site
Edmonton, Alberta, T6G 2S2
Study site
Halifax, Nova Scotia, B3H2Y9
Study site
Montreal, Quebec, H1T 2M4
Study site
Montreal, Quebec, H2L 4M1
Study site
Québec, Quebec, G1R 2J6
Study site
Saskatoon, Saskatchewan, S7N 0W8
Study site
Toronto, Ontario, M5G 2C4
Study site
Vancouver, British Columbia, V5Z 1M9
Study site
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: A Randomized, Open-label Study of the Achievement of a Mycophenolic Acid Therapeutic Window During Treatment With 2 Dosing Regimens of Oral CellCept Administered as a Component of Standard Immunosuppressive Therapy in Patients With Kidney Transplants
This study will compare the efficacy and safety of 2 dosing regimens of oral CellCept administered as a component of standard immunosuppressive therapy in recipients of kidney transplants. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
- Conditions
- Kidney Transplantation
- Being tested
- mycophenolate mofetil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called CellCept
1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving therapeutic window by Day 5\n
Secondary outcomes (1)
Efficacy: Achieving therapeutic window at Day 3, maintaining therapeutic window at day of discharge, Months 1, 3, and 6\nSafety: Renal function, opportunistic infections, malignancies, and adverse events\n
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startJun 2005
- Primary completionMay 2008
- Study completionMay 2008
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788567
- Sponsor's protocol ID
- ML18496
- Status last verified
- Nov 2015
- First submitted
- 10 Nov 2008
- Last updated
- 3 Nov 2015
- Results posted
- No
Publications
Gourishankar S, Houde I, Keown PA, Landsberg D, Cardella CJ, Barama AA, Dandavino R, Shoker A, Pirc L, Wrobel MM, Kiberd BA. The CLEAR study: a 5-day, 3-g loading dose of mycophenolate mofetil versus standard 2-g dosing in renal transplantation. Clin J Am Soc Nephrol. 2010 Jul;5(7):1282-9. doi: 10.2215/CJN.09091209. Epub 2010 May 24.
PubMed 20498245
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study of the Achievement of a Mycophenolic Acid Therapeutic Window During Treatment With 2 Dosing Regimens of Oral CellCept Administered as a Component of Standard Immunosuppressive Therapy in Patients With Kidney Transplants
- ClinicalTrials.gov ID
- NCT00788567
- Acronym / sponsor ID
- ML18496
- Conditions
- Kidney Transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 11 Nov 2008 (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 compare the efficacy and safety of 2 dosing regimens of oral CellCept administered as a component of standard immunosuppressive therapy in recipients of kidney transplants. The anticipated time on study treatment is 3-12 months, 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
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: mycophenolate mofetil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients >=18 years of age;
- recipients of a primary kidney transplant.
Key exclusion criteria (4 listed)
- positive for HIV-1, human T-cell leukemia/lymphoma virus-1 (HTLV-1), or hepatitis B surface antigen;
- positive for hepatitis C virus, with moderate or severe liver disease;
- active malignancy or history of malignancy, excluding skin cancer (basal or squamous cell) that has been adequately treated;
- need for maintenance corticosteroids for another condition.
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 mofetilAlso: CellCept1 | Drug | 1 |
Primary outcome
Proportion of patients achieving therapeutic window by Day 5\n
1 secondary outcome
Efficacy: Achieving therapeutic window at Day 3, maintaining therapeutic window at day of discharge, Months 1, 3, and 6\nSafety: Renal function, opportunistic infections, malignancies, and adverse events\n
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 3 Nov 2015.
- Derived from this study: PubMed 20498245Gourishankar S, Houde I, Keown PA, Landsberg D, Cardella CJ, Barama AA, Dandavino R, Shoker A, Pirc L, Wrobel MM, Kiberd BA. The CLEAR study: a 5-day, 3-g loading dose of mycophenolate mofetil versus standard 2-g dosing in renal transplantation. Clin J Am Soc Nephrol. 2010 Jul;5(7):1282-9. doi: 10.2215/CJN.09091209. Epub 2010 May 24.
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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 chair
Hoffmann-La Roche
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mycophenolate mofetil in people with Kidney Transplantation, run by Hoffmann-La Roche at 9 sites in Canada.
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 2 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 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 achieving therapeutic window by Day 5\n. 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 NCT00788567, 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 3 Nov 2015.