Renal TransplantationPhase 4NCT00238953
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
A Phase 4 study testing Enteric-Coated Mycophenolate Sodium (EC-MPS) in people with Renal Transplantation, run by Novartis at 1 site in Switzerland.
Trial summary
Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2005to Jun 2006
- 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
- Adult, Older adult
Who may be able to join
- Male and females aged 18 to 75
- Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-ME, with or without corticosteroids, as primary immunosuppression
Who cannot join
- Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney.
- Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose).
- Patients with thrombocytopenia (< 75,000/mm3), with an absolute neutrophil count of < 1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at Screening or Baseline.
- Other inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open Label Protocol to Assess the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.
- Conditions
- Renal Transplantation
- Being tested
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Keywords
- Kidney transplantation, enteric-coated mycophenolate sodium
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
| Study group | Role | What they receive |
|---|---|---|
| EC MPS | Experimental | Not described Receives: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Month evaluation
patient and graft survival
acute rejection (suspected or biopsy confirmed)
graft function (serum creatinine, calculated creatinine clearance and glomerular filtration rate),
infections, adverse events, serious adverse events.
Secondary outcomes (1)
Influence of parameters: demography, medical conditions, complications post transplantation on main clinical outcomes. 6 month evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startFeb 2005
- Primary completionJun 2006
- Study completionJun 2006
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 Renal 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238953
- Sponsor's protocol ID
- CERL080APL01
- Status last verified
- Feb 2017
- First submitted
- 12 Oct 2005
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
Wyzgal J, Niemczyk M, Ziolkowski J, Durlik M, Wiecek A. Results of a 6-month, multicenter, open-label, prospective study concerning efficacy and safety of mycophenolate sodium in de novo kidney transplant recipients. Transplant Proc. 2007 Nov;39(9):2730-2. doi: 10.1016/j.transproceed.2007.08.071.
PubMed 18021971
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label Protocol to Assess the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT00238953
- Acronym / sponsor ID
- CERL080APL01
- Conditions
- Renal Transplantation
- Keywords
- Kidney transplantation, enteric-coated mycophenolate sodium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 14 Oct 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.
Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EC MPS | Experimental | Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and females aged 18 to 75
- Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-ME, with or without corticosteroids, as primary immunosuppression
Key exclusion criteria (4 listed)
- Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney.
- Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose).
- Patients with thrombocytopenia (< 75,000/mm3), with an absolute neutrophil count of < 1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at Screening or Baseline.
- Other 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 | EC MPS |
Primary outcome
6 Month evaluation
patient and graft survival
acute rejection (suspected or biopsy confirmed)
graft function (serum creatinine, calculated creatinine clearance and glomerular filtration rate),
infections, adverse events, serious adverse events.
1 secondary outcome
Influence of parameters: demography, medical conditions, complications post transplantation on main clinical outcomes. 6 month evaluation
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 23 Feb 2017.
- Results publication: PubMed 18021971Wyzgal J, Niemczyk M, Ziolkowski J, Durlik M, Wiecek A. Results of a 6-month, multicenter, open-label, prospective study concerning efficacy and safety of mycophenolate sodium in de novo kidney transplant recipients. Transplant Proc. 2007 Nov;39(9):2730-2. doi: 10.1016/j.transproceed.2007.08.071.
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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 Renal Transplantation, 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 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 23 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?
6 Month evaluation. The study lists 5 primary outcomes in all. 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 NCT00238953, 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 23 Feb 2017.