Kidney TransplantationPhase 4NCT00284947
Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids
A Phase 4 study testing basiliximab, MMF/EC-MPS and Corticosteroids in people with Kidney Transplantation and Adverse Effects, run by Novartis at 1 site in Switzerland.
Trial summary
The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney transplantation is associated with renal dysfunction and hypertension. The study will evaluate the safety and efficacy of replacing the calcineurin inhibitors by using basiliximab at monthly doses. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplantation, Adverse Effects
- What is being tested?
- basiliximab, MMF/EC-MPS and Corticosteroids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2006to Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a first kidney transplant from a living or deceased donor at least 12 months after transplantation.
- Patients receiving CNI, mycophenolic acid (MPA) and oral corticosteroids.
- Patients who are able to tolerate full dose MPA.
- Patients with glomerular filtration rate (GFR) > 30 mL/min.
- Patients without an acute rejection episode during the preceding 6 months.
- Patients with signs or symptoms of CNI intolerance (renal dysfunction, poor blood pressure control, diabetes, poor lipid control, hyperuricemia and gout, significant hypophosphatemia or hypomagnesemia, gingival hyperplasia, hypertrichosis, etc.) in whom CNI interruption is justified.
Who cannot join
- Patients with preformed positive skin test against basiliximab
- Patients with preformed panel reactive antibody (PRA) > 10%.
- Signs of active immune process on graft biopsy.
- Patients with multi-organ or second kidney transplant
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REPLACE: Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids
The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney transplantation is associated with renal dysfunction and hypertension. The study will evaluate the safety and efficacy of replacing the calcineurin inhibitors by using basiliximab at monthly doses.
- Conditions
- Kidney Transplantation, Adverse Effects
- Being tested
- basiliximab, MMF/EC-MPS, Corticosteroids
- Keywords
- Side effects, calcineurin inhibitors, maintenance, basiliximab, Kidney maintenance transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
basiliximabDrug
Also called Simulect
40 mg once every 28 days intravenously for 24 weeks
MMF/EC-MPSDrug
Also called MPA, Myfortic, Cellcept
1g MMF or 720mg EC-MPS p.o twice daily
CorticosteroidsDrug
Also called Prednisone, Methyl-prednisolone
Oral corticosteroids, equivalent to prednisone p.o, ≥ 5mg daily or ≥ 10mg on alternate days
| Study group | Role | What they receive |
|---|---|---|
| Maintenance immunosuppression | Experimental | 40mg Simulect i.v, once every 28 days for 24 weeks (treatment periods)
* 1g MMF or 720mg EC-MPS p.o twice daily
* Oral corticosteroids Receives: Drug: basiliximab; Drug: MMF/EC-MPS; Drug: Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
to describe the pharmacokinetics of basiliximab over the 6-month study course and to determine whether serum concentrations remain above CD25 receptor saturation levels
Measured: 6 months
Secondary outcomes (5)
to evaluate the risk of sensitization against the chimeric antibody over 6 months
Measured: 6 months
to assess the changes in renal parameters after CNI discontinuation
Measured: Month 1-6 post trasnplant
to assess the quantifiable changes in vital signs and lab abnormalities possibly related to CNIs
Measured: 6 months
to assess semi-quantitatively changes of clinical symptoms possibly related to CNIs
Measured: 6 month
to determine the percentage of CD25 positive T cells (CD3) during therapy with Simulect
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2008
- Study completionDec 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.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284947
- Sponsor's protocol ID
- CCHI621A2402
- Status last verified
- Mar 2017
- First submitted
- 30 Jan 2006
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REPLACE: Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids
- ClinicalTrials.gov ID
- NCT00284947
- Acronym / sponsor ID
- CCHI621A2402
- Conditions
- Kidney Transplantation, Adverse Effects
- Keywords
- Side effects, calcineurin inhibitors, maintenance, basiliximab, Kidney maintenance transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Feb 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.
The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney transplantation is associated with renal dysfunction and hypertension. The study will evaluate the safety and efficacy of replacing the calcineurin inhibitors by using basiliximab at monthly doses.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance immunosuppression | Experimental | Drug: basiliximab, Drug: MMF/EC-MPS, Drug: Corticosteroids40mg Simulect i.v, once every 28 days for 24 weeks (treatment periods) * 1g MMF or 720mg EC-MPS p.o twice daily * Oral corticosteroids |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a first kidney transplant from a living or deceased donor at least 12 months after transplantation.
- Patients receiving CNI, mycophenolic acid (MPA) and oral corticosteroids.
- Patients who are able to tolerate full dose MPA.
- Patients with glomerular filtration rate (GFR) > 30 mL/min.
- Patients without an acute rejection episode during the preceding 6 months.
Key exclusion criteria (5 listed)
- Patients with preformed positive skin test against basiliximab
- Patients with preformed panel reactive antibody (PRA) > 10%.
- Signs of active immune process on graft biopsy.
- Patients with multi-organ or second kidney transplant
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| basiliximabAlso: Simulect40 mg once every 28 days intravenously for 24 weeks | Drug | Maintenance immunosuppression |
| MMF/EC-MPSAlso: MPA, Myfortic, Cellcept1g MMF or 720mg EC-MPS p.o twice daily | Drug | Maintenance immunosuppression |
| CorticosteroidsAlso: Prednisone, Methyl-prednisoloneOral corticosteroids, equivalent to prednisone p.o, ≥ 5mg daily or ≥ 10mg on alternate days | Drug | Maintenance immunosuppression |
Primary outcome
to describe the pharmacokinetics of basiliximab over the 6-month study course and to determine whether serum concentrations remain above CD25 receptor saturation levels
Time frame: 6 months
5 secondary outcomes
to evaluate the risk of sensitization against the chimeric antibody over 6 months
Time frame: 6 months
to assess the changes in renal parameters after CNI discontinuation
Time frame: Month 1-6 post trasnplant
to assess the quantifiable changes in vital signs and lab abnormalities possibly related to CNIs
Time frame: 6 months
to assess semi-quantitatively changes of clinical symptoms possibly related to CNIs
Time frame: 6 month
to determine the percentage of CD25 positive T cells (CD3) during therapy with Simulect
Time frame: 24 weeks
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 29 Mar 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.
Novartis study director
Novartis
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 basiliximab, MMF/EC-MPS and Corticosteroids in people with Kidney Transplantation and Adverse Effects, run by Novartis at 1 site in Switzerland.
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 6 inclusion and 5 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 29 Mar 2017. 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 Switzerland. 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?
to describe the pharmacokinetics of basiliximab over the 6-month study course and to determine whether serum concentrations remain above CD25 receptor saturation levels (time frame: 6 months). 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 29 Mar 2017.