Kidney TransplantPhase 4NCT00537862
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant Recipients
A Phase 4 study testing Enteric-Coated Mycophenolate Sodium (EC-MPS) in people with Kidney Transplant, run by Novartis Pharmaceuticals at 8 sites in South Korea.
Trial summary
This study will evaluate the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) in a cyclosporine microemulsion based regimen with C2 monitoring in de novo kidney transplant recipients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- How many people
- 200 participants
- Where
- 8 sitesSouth Korea
- Study dates
- May 2006to Feb 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 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Korean Males and females aged 18 to 65 years.
- Recipients of first, living unrelated or living related non-HLA identical donor kidney
- Transplant, treated with cyclosporine microemulsion (Cs-ME) as primary immunosuppressant.
- Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication but at least for four months after randomization, even where there has been a history of infertility.
Who cannot join
- Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ.
- Kidneys from cadaveric donors or HLA identical living related donors.
- Patients with any known hypersensitivity to enteric coated Mycophenolate sodium (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 (<4,000/mm3 ), or hemoglobin < 6g/dL .
- Patients who have received any investigational drug within 30 days prior to study entry.
- Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin.
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- Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
- Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication, and/or presence of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus.
- Patients with clinically significant infection requiring continued therapy.
- Known positive HIV status.
- Positive HBsAg test, or Hepatitis C positive with advanced liver disease or with clinical or pathological diagnosis of cirrhosis.
- Evidence of drug and/or alcohol abuse
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Novartis Investigative Site
Busan, (614-735)
Novartis Investigative Site
Daegu, (700-712)
Novartis Investigative Site
Daegu, (700-721)
Novartis Investigative Site
Jeollanam-do, (501-757)
Novartis Investigative Site
Seoul, (110-744)
Novartis Investigative Site
Seoul, (120-752)
Novartis Investigative Site
Seoul, (137-701)
Novartis Investigative Site
Seoul, (138-736)
About this study
Official title: Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant Recipients ; A Prospective, Open Label, Multi-center Study
This study will evaluate the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) in a cyclosporine microemulsion based regimen with C2 monitoring in de novo kidney transplant recipients
- Conditions
- Kidney Transplant
- Being tested
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Keywords
- Kidney Transplant Patients, Immunosuppresion, 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy & safety of enteric-coated mycophenolate sodium combined with cyclosporine microemulsion & corticosteroids assessed by overall survival at 6 months, biopsy proven acute rejection, graft loss, adverse events and serious adverse events.
Secondary outcomes (1)
Tolerability of full dose of EC-MPS assessed by dose reduction & treatment discontinuation rates due to adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startMay 2006
- Primary completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
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
- NCT00537862
- Sponsor's protocol ID
- CERL080AKR02
- Status last verified
- Feb 2017
- First submitted
- 1 Oct 2007
- Last updated
- 24 Feb 2017
- Results posted
- No
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
- Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant Recipients ; A Prospective, Open Label, Multi-center Study
- ClinicalTrials.gov ID
- NCT00537862
- Acronym / sponsor ID
- CERL080AKR02
- Conditions
- Kidney Transplant
- Keywords
- Kidney Transplant Patients, Immunosuppresion, Enteric-coated mycophenolate sodium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Feb 2007 (actual)
- First posted
- 2 Oct 2007 (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.
This study will evaluate the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) in a cyclosporine microemulsion based regimen with C2 monitoring in de novo kidney transplant recipients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Korean Males and females aged 18 to 65 years.
- Recipients of first, living unrelated or living related non-HLA identical donor kidney
- Transplant, treated with cyclosporine microemulsion (Cs-ME) as primary immunosuppressant.
- Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication but at least for four months after randomization, even where there has been a history of infertility.
Key exclusion criteria (13 listed)
- Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ.
- Kidneys from cadaveric donors or HLA identical living related donors.
- Patients with any known hypersensitivity to enteric coated Mycophenolate sodium (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 (<4,000/mm3 ), or hemoglobin < 6g/dL .
- Patients who have received any investigational drug within 30 days prior to study entry.
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
Efficacy & safety of enteric-coated mycophenolate sodium combined with cyclosporine microemulsion & corticosteroids assessed by overall survival at 6 months, biopsy proven acute rejection, graft loss, adverse events and serious adverse events.
1 secondary outcome
Tolerability of full dose of EC-MPS assessed by dose reduction & treatment discontinuation rates due to adverse events
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.
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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
8 sites 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 Transplant, run by Novartis Pharmaceuticals at 8 sites in South Korea.
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 13 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 8 sites in South Korea. 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?
Efficacy & safety of enteric-coated mycophenolate sodium combined with cyclosporine microemulsion & corticosteroids assessed by overall survival at 6 months, biopsy proven acute rejection, graft loss, adverse events and serious adverse events.. 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 24 Feb 2017.