Renal TransplantationPhase 4NCT00154232
Study to Evaluate the Combination of Enteric-coated Mycophenolate Sodium (EC-MPS), Basiliximab, and C2-monitored Cyclosporine in de Novo Renal Transplant Recipients at Potential High Risk of Delayed Graft Function (DGF)
A Phase 4 study testing Enteric-Coated Mycophenolate Sodium (EC-MPS) in people with Renal Transplantation, run by Novartis Pharmaceuticals.
Trial summary
The aim of the study is to assess the short-term benefit of the combination of basiliximab, EC-MPS and cyclosporine microemulsion with C2 monitoring on the prophylaxis of acute rejection in a population of de novo renal transplant patients at potential high risk of DGF. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Mar 2005
- 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
- Adult, Older adult
Who may be able to join
- Age 18-70 years old
- Patients receiving a primary or secondary cadaveric or living donor kidney
- Patients who have given written informed consent for study participation
- Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice birth control for the duration of the study and at least for four months following the last dose of basiliximab.
Who cannot join
- Recipient of multi-organ transplants or previously transplanted organs other than kidney
- Recipient of dual kidney transplants
- Recipient of a transplanted kidney from a Non-Heart Beating Donor (NHBD)
- Recipient of a HLA identical living-donor kidney
- Patients with a PRA level (past or current level) greater than 20%
- Patients anticipated by investigators to require induction therapy with OKT3, ATGAM, or Thymoglobulin for any reason
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- Patients with any medical condition which, in the opinion of the investigator, would preclude the patient from participating in the study
- Cold ischemia time larger than 36 hours.
- Patients who have received an investigational drug or therapy within one month prior to study entry or if such therapy is to be instituted post-transplantation.
- Female transplant candidates who are pregnant, lactating, or of childbearing potential and not willing to practice an acceptable method of contraception
- Patients with a known hypersensitivity to cyclosporine
- Patients with a known malignancy or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin
- Known HIV positive antibody status
- Evidence of any clinically relevant (per investigator determination) active infection
- Patients unable to participate in the study for the full 3-month study period
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A 3 Month, Multicenter, Open-label Study to Evaluate the Impact of the Immunosuppressive Combination of Enteric-Coated Mycophenolate Sodium (EC- MPS), Basiliximab and Cyclosporine for Microemulsion With C2 Monitoring, on Efficacy and Safety Outcomes in de Novo Kidney Transplant Recipients at Potential High Risk of DGF.
The aim of the study is to assess the short-term benefit of the combination of basiliximab, EC-MPS and cyclosporine microemulsion with C2 monitoring on the prophylaxis of acute rejection in a population of de novo renal transplant patients at potential high risk of DGF.
- Conditions
- Renal Transplantation
- Being tested
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Keywords
- Renal transplantation, DGF, basiliximab, EC-MPS, cyclosporine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteric-Coated Mycophenolate Sodium (EC-MPS)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of first episodes of BPAR at month 3 post transplant
Secondary outcomes (7)
Incidence of patients death at month 3 post transplant.
Incidence of graft loss or, synonymously, graft failure)
The allograft will defined as lost (or: to have failed)
when the patient begins dialysis treatments without
subsequent graft recovery.
The time of graft failure will be defined as the time of start of dialysis, or time of nephrectomy, whatever occurs first.
Number of myfortic dose adjustments/discontinuations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154232
- Sponsor's protocol ID
- CERL080AAR01
- Status last verified
- Nov 2011
- First submitted
- 7 Sep 2005
- Last updated
- 2 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3 Month, Multicenter, Open-label Study to Evaluate the Impact of the Immunosuppressive Combination of Enteric-Coated Mycophenolate Sodium (EC- MPS), Basiliximab and Cyclosporine for Microemulsion With C2 Monitoring, on Efficacy and Safety Outcomes in de Novo Kidney Transplant Recipients at Potential High Risk of DGF.
- ClinicalTrials.gov ID
- NCT00154232
- Acronym / sponsor ID
- CERL080AAR01
- Conditions
- Renal Transplantation
- Keywords
- Renal transplantation, DGF, basiliximab, EC-MPS, cyclosporine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Mar 2005 (actual)
- First posted
- 12 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.
The aim of the study is to assess the short-term benefit of the combination of basiliximab, EC-MPS and cyclosporine microemulsion with C2 monitoring on the prophylaxis of acute rejection in a population of de novo renal transplant patients at potential high risk of DGF.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70 years old
- Patients receiving a primary or secondary cadaveric or living donor kidney
- Patients who have given written informed consent for study participation
- Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice birth control for the duration of the study and at least for four months following the last dose of basiliximab.
Key exclusion criteria (16 listed)
- Recipient of multi-organ transplants or previously transplanted organs other than kidney
- Recipient of dual kidney transplants
- Recipient of a transplanted kidney from a Non-Heart Beating Donor (NHBD)
- Recipient of a HLA identical living-donor kidney
- Patients with a PRA level (past or current level) greater than 20%
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 |
|---|---|---|
| Enteric-Coated Mycophenolate Sodium (EC-MPS) | Drug | – |
Primary outcome
Incidence of first episodes of BPAR at month 3 post transplant
7 secondary outcomes
Incidence of patients death at month 3 post transplant.
Incidence of graft loss or, synonymously, graft failure)
The allograft will defined as lost (or: to have failed)
when the patient begins dialysis treatments without
subsequent graft recovery.
The time of graft failure will be defined as the time of start of dialysis, or time of nephrectomy, whatever occurs first.
Number of myfortic dose adjustments/discontinuations
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 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.
Novartis study director
Novartis
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enteric-Coated Mycophenolate Sodium (EC-MPS) in people with Renal Transplantation, run by Novartis Pharmaceuticals.
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 16 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 2011. 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 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?
Incidence of first episodes of BPAR at month 3 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 2011.