Kidney TransplantationPhase 4NCT00229138
Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients
A Phase 4 study testing EC-MPS, Tacrolimus in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- EC-MPS, Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Mar 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 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- Male or female kidney transplantation patients, 18 to 70 years of age, receiving a primary cadaveric, living unrelated, or non-HLA identical living related donor kidney.
- The renal cold ischemic time (CIT) must be <30 hours
- The age of the donor must be between 10 and 65 years
Who cannot join
- Patients who have previously received an organ transplant
- Patients who are recipients of a multiple organ transplants
- Recipients of non heart-beating donor organs
- ABO incompatibility against the donor
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Six-month, Prospective, Multicenter, Open Label, Parallel, Randomized Study of the Safety, Tolerability and Efficacy of EC-MPS With Basiliximab, Corticosteroids and Two Different Levels of Tacrolimus in de Novo Renal Transplant Recipients
This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.
- Conditions
- Kidney Transplantation
- Being tested
- EC-MPS, Tacrolimus
- Keywords
- De novo kidney recipients,, EC-MPS,, tacrolimus,, efficacy,, safety,, glomerular filtration rate, Treatment in de novo kidney recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC-MPS, TacrolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| reduced Tacrolimus | Experimental | Not described Receives: Drug: EC-MPS, Tacrolimus |
| Reference Tacrolimus | Active comparator | Not described Receives: Drug: EC-MPS, Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal function at 6 months posttransplant as measured by glomerular filtration rate
Measured: 6 months
Secondary outcomes (7)
Efficacy as measured by combined incidence of biopsy proven acute rejection episodes, graft loss, and death at 6 months
Renal function as measured by calculated creatinine clearance
Cockcroft-Gaultand serum creatinine at 6 months
Gastrointestinal tolerability as measured by gastrointestinal
symptom rating scale (GSRS) at various time points
Safety as measured by incidence of adverse events
Effects on glucose metabolism at months 3 and 6 after transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionMar 2007
- Study completionMar 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 291 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
- NCT00229138
- Sponsor's protocol ID
- CERL080A2409
- Status last verified
- Feb 2017
- First submitted
- 27 Sep 2005
- Last updated
- 7 Feb 2017
- Results posted
- No
Publications
Chan L, Andres A, Bunnapradist S, Gugliuzza K, Parasuraman R, Peddi VR, Cassuto E, Hart M. Renal Function and NODM in De Novo Renal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS. J Transplant. 2012;2012:941640. doi: 10.1155/2012/941640. Epub 2012 Nov 25.
PubMed 23227307
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six-month, Prospective, Multicenter, Open Label, Parallel, Randomized Study of the Safety, Tolerability and Efficacy of EC-MPS With Basiliximab, Corticosteroids and Two Different Levels of Tacrolimus in de Novo Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT00229138
- Acronym / sponsor ID
- CERL080A2409
- Conditions
- Kidney Transplantation
- Keywords
- De novo kidney recipients,, EC-MPS,, tacrolimus,, efficacy,, safety,, glomerular filtration rate, Treatment in de novo kidney recipients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 29 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.
This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reduced Tacrolimus | Experimental | Drug: EC-MPS, Tacrolimus |
| Reference Tacrolimus | Active comparator | Drug: EC-MPS, Tacrolimus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female kidney transplantation patients, 18 to 70 years of age, receiving a primary cadaveric, living unrelated, or non-HLA identical living related donor kidney.
- The renal cold ischemic time (CIT) must be <30 hours
- The age of the donor must be between 10 and 65 years
Key exclusion criteria (5 listed)
- Patients who have previously received an organ transplant
- Patients who are recipients of a multiple organ transplants
- Recipients of non heart-beating donor organs
- ABO incompatibility against the donor
- Other protocol-defined 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 |
|---|---|---|
| EC-MPS, Tacrolimus | Drug | Reference Tacrolimus, reduced Tacrolimus |
Primary outcome
renal function at 6 months posttransplant as measured by glomerular filtration rate
Time frame: 6 months
7 secondary outcomes
Efficacy as measured by combined incidence of biopsy proven acute rejection episodes, graft loss, and death at 6 months
Renal function as measured by calculated creatinine clearance
Cockcroft-Gaultand serum creatinine at 6 months
Gastrointestinal tolerability as measured by gastrointestinal
symptom rating scale (GSRS) at various time points
Safety as measured by incidence of adverse events
Effects on glucose metabolism at months 3 and 6 after transplantation.
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 7 Feb 2017.
- Results publication: PubMed 23227307Chan L, Andres A, Bunnapradist S, Gugliuzza K, Parasuraman R, Peddi VR, Cassuto E, Hart M. Renal Function and NODM in De Novo Renal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS. J Transplant. 2012;2012:941640. doi: 10.1155/2012/941640. Epub 2012 Nov 25.
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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 EC-MPS, Tacrolimus in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 1 site in United States.
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 3 inclusion and 5 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 7 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 United States. 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?
renal function at 6 months posttransplant as measured by glomerular filtration rate (time frame: 6 months). 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 NCT00229138, 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 7 Feb 2017.