Kidney TransplantationPhase 4NCT00434590
Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients
A Phase 4 study testing Enteric coated mycophenolate sodium (Myfortic®) in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 1 site in Italy.
Trial summary
The study will evaluate kidney graft function in maintenance renal transplant patients. 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?
- Enteric coated mycophenolate sodium (Myfortic®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2007to May 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult, Older adult
Who may be able to join
- Male or female recipients of single or double renal transplant performed since at least one year and no more that 5 years
- Age > 18 yrs
- Adequate and stable renal function
- Informed consent.
Who cannot join
- Kidney transplant combined with other organs;
- Significant proteinuria
- Severe ongoing infections;
- Present or historical malignant neoplasia, of any type, with the exception of excised non metastatic non-melanoma skin cancer and previous malignant neoplasia cured since at least 5 years;
- Relapse of the end-stage renal disease on the transplanted kidney;
- Leucopenia, thrombocytopenia or severe anemia;
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled, Randomized, Parallel Group Study to Assess Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients
The study will evaluate kidney graft function in maintenance renal transplant patients.
- Conditions
- Kidney Transplantation
- Being tested
- Enteric coated mycophenolate sodium (Myfortic®)
- Keywords
- Kidney Transplantation, Mycophenolic Acid, Immunosuppression, Cyclosporine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteric coated mycophenolate sodium (Myfortic®)Drug
Also called Myfortic
| Study group | Role | What they receive |
|---|---|---|
| Full Dose Myfortic® and Reduced Dose Neoral® | Experimental | The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME Receives: Drug: Enteric coated mycophenolate sodium (Myfortic®) |
| Standard Dose of Myfortic® and Standard Dose of CsA-ME | Active comparator | Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME. Receives: Drug: Enteric coated mycophenolate sodium (Myfortic®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months
The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity.
Measured: 12 months
Secondary outcomes (5)
Creatinine Clearance at 12 Months
Measured: 12 months
Serum Creatinine at 12 Months
Measured: 12 months
Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months
Measured: 12 months
Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months
Measured: 12 months
Chronic Rejection as Confirmed by Renal Biopsy at 12 Months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: The study has been stopped because of the lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434590
- Sponsor's protocol ID
- CERL080AIT09
- Status last verified
- Mar 2011
- First submitted
- 12 Feb 2007
- Last updated
- 7 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled, Randomized, Parallel Group Study to Assess Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT00434590
- Acronym / sponsor ID
- CERL080AIT09
- Conditions
- Kidney Transplantation
- Keywords
- Kidney Transplantation, Mycophenolic Acid, Immunosuppression, Cyclosporine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been stopped because of the lack of enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008
- First posted
- 13 Feb 2007 (estimated)
- Results
- Posted 7 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate kidney graft function in maintenance renal transplant patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Dose Myfortic® and Reduced Dose Neoral® | Experimental | Drug: Enteric coated mycophenolate sodium (Myfortic®)The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME |
| Standard Dose of Myfortic® and Standard Dose of CsA-ME | Active comparator | Drug: Enteric coated mycophenolate sodium (Myfortic®)Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female recipients of single or double renal transplant performed since at least one year and no more that 5 years
- Age > 18 yrs
- Adequate and stable renal function
- Informed consent.
Key exclusion criteria (7 listed)
- Kidney transplant combined with other organs;
- Significant proteinuria
- Severe ongoing infections;
- Present or historical malignant neoplasia, of any type, with the exception of excised non metastatic non-melanoma skin cancer and previous malignant neoplasia cured since at least 5 years;
- Relapse of the end-stage renal disease on the transplanted kidney;
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 (Myfortic®)Also: Myfortic | Drug | Full Dose Myfortic® and Reduced Dose Neoral®, Standard Dose of Myfortic® and Standard Dose of CsA-ME |
Primary outcome
Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months
Time frame: 12 months
The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity.
5 secondary outcomes
Creatinine Clearance at 12 Months
Time frame: 12 months
Serum Creatinine at 12 Months
Time frame: 12 months
Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months
Time frame: 12 months
Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months
Time frame: 12 months
Chronic Rejection as Confirmed by Renal Biopsy at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Kidney Transplantation
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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 Enteric coated mycophenolate sodium (Myfortic®) in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 1 site in Italy.
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 7 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: stopped early, as of the sponsor's last update on 7 Apr 2011. 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 Italy. 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?
Yes. Results are posted in the registry (first posted 7 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Assessed by Glomerular Filtration Rate (GFR) at 12 Months (time frame: 12 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 7 Apr 2011.