Kidney TransplantationPhase 3NCT00048152
A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients
A Phase 3 study testing Corticosteroids, Neoral and Zenapax in people with Kidney Transplantation, run by Hoffmann-La Roche at 36 sites in 12 countries.
Trial summary
This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 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?
- Corticosteroids, Neoral and Zenapax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 539 participants
- Where
- 36 sitesin 12 countries
- Study dates
- Dec 2000to Mar 2006
- 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 greater than 18 years of age
- recipients of primary kidney transplant
- single-organ recipients (kidney only)
Who cannot join
- previous treatment with Zenapax
- history of malignancy (except localized skin cancer)
Trial locations and contacts
36 sites in 12 countries.
36 sites in 12 countries
United States8 sites
Study site
Atlanta, Georgia, 30322
Study site
Birmingham, Alabama, 35294
Study site
Charleston, South Carolina, 29425-0777
Study site
Falls Church, Virginia, 22042-3300
Study site
Gainesville, Florida, 32610
Study site
Livingston, New Jersey, 07039
Study site
Philadelphia, Pennsylvania, 19102-1192
Study site
San Francisco, California, 94143
Spain6 sites
Study site
Barcelona, 08036
Study site
Barcelona, 08907
Study site
Córdoba, 14004
Study site
Málaga, 29010
Study site
Santander, 39008
Study site
Valencia, 46009
Canada4 sites
Study site
Calgary, Alberta, T2N 2T9
Study site
Edmonton, Alberta, T6G 2R8
Study site
Saskatoon, Saskatchewan, S7N 0W8
Study site
Vancouver, British Columbia, V6Z 1Y6
Germany3 sites
Study site
Berlin, 13353
Study site
Hanover, 30625
Study site
Münster, 48149
United Kingdom3 sites
Study site
Birmingham, B15 2TH
Study site
Glasgow, G11 6NT
Study site
Leicester, LE5 4PW
About this study
Official title: A Randomized, Open-label Study Comparing the Effects of Low-dose Cyclosporine vs Cyclosporine Withdrawal on Renal Function in Kidney Transplant Patients Treated With CellCept and Daclizumab
This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.
- Conditions
- Kidney Transplantation
- Being tested
- Corticosteroids, Neoral, Zenapax, mycophenolate mofetil [CellCept]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidsDrug
As prescribed
NeoralDrug
Low dose (target trough level 50-100ng/mL)
NeoralDrug
Standard dose (target trough level 150-300ng/mL)
ZenapaxDrug
2mg/kg iv first dose, then 1mg/kg every 2 weeks
mycophenolate mofetil [CellCept]Drug
1g po bid
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Corticosteroids; Drug: Neoral; Drug: Zenapax; Drug: mycophenolate mofetil [CellCept] |
| 2 | Experimental | Not described Receives: Drug: Corticosteroids; Drug: Neoral; Drug: Zenapax; Drug: mycophenolate mofetil [CellCept] |
| 3 | Experimental | Not described Receives: Drug: Corticosteroids; Drug: Neoral; Drug: mycophenolate mofetil [CellCept] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function (as measured by GFR)
Measured: 12 months post-transplant
Secondary outcomes (3)
Patient and graft survival \n
Measured: 12 months post-transplant
Proportion of patients with biopsy-proven rejection; treatment failure.
Measured: 6 and 12 months post-transplant
AEs, OIs, malignancies, deaths
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 posted25 Oct 2002 (estimated)
- Study startDec 2000
- Primary completionMar 2006
- Study completionMar 2006
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 539 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
- NCT00048152
- Sponsor's protocol ID
- M67005
- Status last verified
- Nov 2016
- First submitted
- 24 Oct 2002
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study Comparing the Effects of Low-dose Cyclosporine vs Cyclosporine Withdrawal on Renal Function in Kidney Transplant Patients Treated With CellCept and Daclizumab
- ClinicalTrials.gov ID
- NCT00048152
- Acronym / sponsor ID
- M67005
- Conditions
- Kidney Transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 25 Oct 2002 (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 kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, 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: Corticosteroids, Drug: Neoral, Drug: Zenapax, Drug: mycophenolate mofetil [CellCept] |
| 2 | Experimental | Drug: Corticosteroids, Drug: Neoral, Drug: Zenapax, Drug: mycophenolate mofetil [CellCept] |
| 3 | Experimental | Drug: Corticosteroids, Drug: Neoral, 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 (3 listed)
- adult patients greater than 18 years of age
- recipients of primary kidney transplant
- single-organ recipients (kidney only)
Key exclusion criteria (2 listed)
- previous treatment with Zenapax
- history of malignancy (except localized skin cancer)
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 |
|---|---|---|
| CorticosteroidsAs prescribed | Drug | 1, 2, 3 |
| NeoralLow dose (target trough level 50-100ng/mL) | Drug | 1, 2 |
| NeoralStandard dose (target trough level 150-300ng/mL) | Drug | 3 |
| Zenapax2mg/kg iv first dose, then 1mg/kg every 2 weeks | Drug | 1, 2 |
| mycophenolate mofetil [CellCept]1g po bid | Drug | 1, 2, 3 |
Primary outcome
Renal function (as measured by GFR)
Time frame: 12 months post-transplant
3 secondary outcomes
Patient and graft survival \n
Time frame: 12 months post-transplant
Proportion of patients with biopsy-proven rejection; treatment failure.
Time frame: 6 and 12 months post-transplant
AEs, OIs, malignancies, deaths
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 2 Nov 2016.
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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
36 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Corticosteroids, Neoral and Zenapax in people with Kidney Transplantation, run by Hoffmann-La Roche at 36 sites in 12 countries.
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 3 inclusion and 2 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Spain, Canada, Germany, United Kingdom and 7 more countries. 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?
Renal function (as measured by GFR) (time frame: 12 months post-transplant). 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 2 Nov 2016.