Kidney TransplantationPhase 4NCT00154206
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients
A Phase 4 study testing Enteric-Coated Mycophenolate Sodium (EC-MPS) in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2004to Jan 2007
- 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 5 to 16 years
- All sexes
- Child
Who may be able to join
- Recipients of a primary renal transplantation
- Recipients of a renal transplantation only
Who cannot join
- Recipients of a multi-organ transplantation
- Unable to take an oral medication
- Requiring an induction therapy with polyclonal, monoclonal antibodies (OKT3, ATG, ALG).
- Other protocol-defined inclusion / exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open, Single Arm, Pilot Study to Evaluate Efficacy, Tolerability and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients
The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.
- Conditions
- Kidney Transplantation
- Being tested
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Keywords
- Enteric-coated mycophenolate sodium,, de novo,, renal transplantation,, pediatric, De novo pediatric renal transplantation
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 biopsy-proven-acute-rejection and treatment failure (defined by graft loss and/or biopsy-proven-acute-rejection and/or death and/or lost to follow-up and/or study discontinuation) within the 6 and 12 months post transplantation
Secondary outcomes (7)
Within the 6 and 12 months post transplantation
Incidence of acute rejection resistant to steroids
Incidence of graft loss and death
Renal function by creatinine and creatinine clearance (Schwartz formula)
Incidence of premature study drug discontinuation due to safety reason
Pharmacokinetic profile of Myfortic.
Frequency of adverse events, incidence of clinically notable laboratory abnormalities, and change on vital signs.
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 startSep 2004
- Primary completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT00154206
- Sponsor's protocol ID
- CERL080AFR03
- Status last verified
- Feb 2017
- First submitted
- 8 Sep 2005
- Last updated
- 24 Feb 2017
- Results posted
- No
Publications
Niaudet P, Charbit M, Loirat C, Lapeyraque AL, Tsimaratos M, Cailliez M, Foulard M, Dehennault M, Marquet P, Chaouche-Teyara K, Lemay D. Enteric-coated mycophenolate sodium in de novo pediatric renal transplant patients. Pediatr Nephrol. 2009 Feb;24(2):395-402. doi: 10.1007/s00467-008-1031-7. Epub 2008 Nov 5.
PubMed 18985393
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open, Single Arm, Pilot Study to Evaluate Efficacy, Tolerability and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT00154206
- Acronym / sponsor ID
- CERL080AFR03
- Conditions
- Kidney Transplantation
- Keywords
- Enteric-coated mycophenolate sodium,, de novo,, renal transplantation,, pediatric, De novo pediatric renal transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Jan 2007 (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 this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (2 listed)
- Recipients of a primary renal transplantation
- Recipients of a renal transplantation only
Key exclusion criteria (4 listed)
- Recipients of a multi-organ transplantation
- Unable to take an oral medication
- Requiring an induction therapy with polyclonal, monoclonal antibodies (OKT3, ATG, ALG).
- 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 |
|---|---|---|
| Enteric-Coated Mycophenolate Sodium (EC-MPS) | Drug | – |
Primary outcome
Incidence of biopsy-proven-acute-rejection and treatment failure (defined by graft loss and/or biopsy-proven-acute-rejection and/or death and/or lost to follow-up and/or study discontinuation) within the 6 and 12 months post transplantation
7 secondary outcomes
Within the 6 and 12 months post transplantation
Incidence of acute rejection resistant to steroids
Incidence of graft loss and death
Renal function by creatinine and creatinine clearance (Schwartz formula)
Incidence of premature study drug discontinuation due to safety reason
Pharmacokinetic profile of Myfortic.
Frequency of adverse events, incidence of clinically notable laboratory abnormalities, and change on vital signs.
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 24 Feb 2017.
- Background: PubMed 18985393Niaudet P, Charbit M, Loirat C, Lapeyraque AL, Tsimaratos M, Cailliez M, Foulard M, Dehennault M, Marquet P, Chaouche-Teyara K, Lemay D. Enteric-coated mycophenolate sodium in de novo pediatric renal transplant patients. Pediatr Nephrol. 2009 Feb;24(2):395-402. doi: 10.1007/s00467-008-1031-7. Epub 2008 Nov 5.
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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 (EC-MPS) in people with Kidney Transplantation, run by Novartis Pharmaceuticals 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 2 inclusion and 4 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 24 Feb 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?
Incidence of biopsy-proven-acute-rejection and treatment failure (defined by graft loss and/or biopsy-proven-acute-rejection and/or death and/or lost to follow-up and/or study discontinuation) within the 6 and 12 months post transplantation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00154206, which also lists 1 linked publication.
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 24 Feb 2017; AzTrials last refreshed its copy on 7 Nov 2026.