Kidney TransplantationPhase 2/3NCT00729768
A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation
A Phase 2/3 study testing basiliximab, efalizumab and mycophenolate mofetil in people with Kidney Transplantation, run by Genentech, Inc..
Trial summary
This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction therapy with basiliximab, as an… 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?
- basiliximab, efalizumab and mycophenolate mofetil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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
- Have signed the informed consent form and the HIPAA patient information form (United States only)
- Are ≥ 18 years of age
- Are a transplant recipient of at least one HLA-mismatch kidney
- For subjects of reproductive potential (men and women), are willing to use effective contraception, unless abstinence is the chosen method
Who cannot join
- Have a history of previous renal transplant
- Have had a PRA > 25% at any time
- Have a history of or evidence of cancer except for basal cell carcinoma that has been excised and cervical carcinoma in situ
- Have a positive T-cell lymphocytotoxic crossmatch with the use of donor lymphocytes and recipient serum
- Have had previous treatment with efalizumab
- Have used any investigational drug within 28 days or 5 half-lives of screening, whichever is longer
Show all 10Show fewer
- Have a known contraindication to efalizumab
- Have a history of severe allergic or anaphylactic reactions to monoclonal antibodies
- Have had a known allergic reaction or intolerance to any of the following medications: CsA; MMF; Corticosteroids; Basiliximab
- Are allergic to iodinated contrast media that would preclude GFR measurement with iothalamate
About this study
Official title: A Phase II/III, Randomized, Open-Label, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Efalizumab Compared With Cyclosporine, Both in Combination With Mycophenolate Mofetil and Corticosteroids, As an Immunosuppressant Regimen in De Novo Renal Transplantation
This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A total of 200 subjects undergoing either living or cadaveric renal transplantation will be randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF + corticosteroids.
- Conditions
- Kidney Transplantation
- Being tested
- basiliximab, efalizumab, mycophenolate mofetil, corticosteroids, cyclosporine
- Keywords
- Renal transplant, Raptiva
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
basiliximabDrug
2 intravenous doses
efalizumabDrug
Subcutaneous repeating dose
Oral repeating dose
corticosteroidsDrug
Repeating doses
cyclosporineDrug
Oral repeating dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: basiliximab; Drug: efalizumab; Drug: mycophenolate mofetil; Drug: corticosteroids |
| 2 | Active comparator | Not described Receives: Drug: basiliximab; Drug: mycophenolate mofetil; Drug: corticosteroids; Drug: cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject and renal allograft survival
Measured: 52 weeks
Secondary outcomes (4)
Glomerular filtration rate
Measured: 12 and 52 weeks
Change in glomerular filtration rate
Measured: 12 weeks to 52 weeks
Transplant renal biopsies
Measured: 52 weeks
Change in metabolic/cardiovascular risk factors
Measured: 24 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
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 Genentech, Inc.The 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729768
- Sponsor's protocol ID
- ACD4230g
- Status last verified
- Mar 2009
- First submitted
- 2 Aug 2008
- Last updated
- 22 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III, Randomized, Open-Label, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Efalizumab Compared With Cyclosporine, Both in Combination With Mycophenolate Mofetil and Corticosteroids, As an Immunosuppressant Regimen in De Novo Renal Transplantation
- ClinicalTrials.gov ID
- NCT00729768
- Acronym / sponsor ID
- ACD4230g
- Conditions
- Kidney Transplantation
- Keywords
- Renal transplant, Raptiva
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- First posted
- 7 Aug 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 is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A total of 200 subjects undergoing either living or cadaveric renal transplantation will be randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF + corticosteroids.
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: basiliximab, Drug: efalizumab, Drug: mycophenolate mofetil, Drug: corticosteroids |
| 2 | Active comparator | Drug: basiliximab, Drug: mycophenolate mofetil, Drug: corticosteroids, Drug: cyclosporine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have signed the informed consent form and the HIPAA patient information form (United States only)
- Are ≥ 18 years of age
- Are a transplant recipient of at least one HLA-mismatch kidney
- For subjects of reproductive potential (men and women), are willing to use effective contraception, unless abstinence is the chosen method
Key exclusion criteria (10 listed)
- Have a history of previous renal transplant
- Have had a PRA > 25% at any time
- Have a history of or evidence of cancer except for basal cell carcinoma that has been excised and cervical carcinoma in situ
- Have a positive T-cell lymphocytotoxic crossmatch with the use of donor lymphocytes and recipient serum
- Have had previous treatment with efalizumab
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 |
|---|---|---|
| basiliximab2 intravenous doses | Drug | 1, 2 |
| efalizumabSubcutaneous repeating dose | Drug | 1 |
| mycophenolate mofetilOral repeating dose | Drug | 1, 2 |
| corticosteroidsRepeating doses | Drug | 1, 2 |
| cyclosporineOral repeating dose | Drug | 2 |
Primary outcome
Subject and renal allograft survival
Time frame: 52 weeks
4 secondary outcomes
Glomerular filtration rate
Time frame: 12 and 52 weeks
Change in glomerular filtration rate
Time frame: 12 weeks to 52 weeks
Transplant renal biopsies
Time frame: 52 weeks
Change in metabolic/cardiovascular risk factors
Time frame: 24 weeks and 52 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
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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
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing basiliximab, efalizumab and mycophenolate mofetil in people with Kidney Transplantation, run by Genentech, Inc..
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 10 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: withdrawn, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Subject and renal allograft survival (time frame: 52 weeks). 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 22 Jun 2017.