Kidney TransplantMORE registryNCT01284257
Observational Registry Study of Renal Transplant Patients
An observational study of Kidney Transplant, run by Novartis Pharmaceuticals at 8 sites in United States.
Trial summary
The MORE Observational Study follows real-world renal transplant patients with the data resolution of a monitored, prospective clinical trial for 5 years. In addition to capturing detailed clinical data, the study describes recent important changes in surveillance testing and drug therapy and relates these changes to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant
- How many people
- 0 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2007to May 2010
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll approximately 1,200 de novo (newly transplanted within 2 weeks) renal transplant patients from approximately 30-60 transplant centers across the United States. Patients should be consented prior to the first dose of MPA, +/- 14 days from the date of the transplant and be enrolled as soon as feasible after transplantation but not later than 2 weeks post-transplantation. Enrollment targets will be capped globally at 800 patients being treated with myfortic® and 400 patients being treated with CellCept®.
Who may be able to join
- 18 years of age or older.
- The de novo recipient of a cadaveric or living donor kidney transplant, within two weeks of transplantation.
- Receiving mycophenolic acid (MPA) therapy of either myfortic® or CellCept®.
- Able to provide informed consent.
- Able to self-administer the ITAS compliance instrument (6 questions).
Who cannot join
- The recipient of multiple organ grafts or prior non-kidney graft.
- Enrolled or plans to enroll in an investigational clinical trial.
- Not likely to have up to 5 year follow-up data available for this study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
BURLINGTON investigational site
Burlington, Vermont
Denver Investigational site
Denver, Colorado
Detroit investigational site
Detroit, Michigan
New York investigational site
New York, New York
PHILADELPHIA investigational site
Philadelphia, Pennsylvania
San Francisco investigational site
San Francisco, California
Seattle investigational site
Seattle, Washington
Springfield investigational site
Springfield, Massachusetts
About this study
Official title: A Phase IV, Non-interventional, Multi-center, Open-label, Prospective, Observational Study of the Safety, Effectiveness, Tolerability and Compliance of Immunosuppressive Regimens Using Mycophenolic Acid to Treat de Novo Renal Transplant Patients in Routine Clinical Practice
The MORE Observational Study follows real-world renal transplant patients with the data resolution of a monitored, prospective clinical trial for 5 years. In addition to capturing detailed clinical data, the study describes recent important changes in surveillance testing and drug therapy and relates these changes to short and long-term outcomes. Also, the study measures patient compliance over time and details the rationale for modifications of MPA dosing in maintenance and regimen changes after episodes of AR. The MORE study will provide information on era changes in transplant practices and their impact on clinical outcome, new insights on optimizing regimens for discrete patient subsets and new perspectives on the optimal use of MPA therapy.
- Conditions
- Kidney Transplant
- Keywords
- EC-MPS, MMF, kidney transplant, outcomes, mycophenolate sodium, mycophenolic acid (MPA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Enteric coated mycophenolate sodium (EC-MPS) arm | Patients to whom EC-MPS is prescribed by their practitioner. | |
| MMF arm | Patients to whom MMF is prescribed by their practitioner. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of EC-MPS or MMF over time
Dosage interruptions, discontinuations and switches between EC-MPS and MMF
Measured: 60 months
Secondary outcomes (4)
Incidence of Gastro-Intestinal (GI) Adverse Events (AEs) in relationship with prior GI history and GI co-medications
Measured: 60 months
The incidence of selected Adverse Events
e.g., viral infections, hematological events, glaucoma, malignancy, diabetes mellitus, cardiovascular events, bone-loss related events, GI events, hepatitis) and associated Serious Adverse Events (SAEs).
Measured: 60 months
Combined outcome measure of biopsy-proven acute rejection (BPAR) episodes, graft loss and death
Measured: 60 months
Center Practices
The center practice will be described as observed. This includes the number of transplants performed per year per center, patient follow up frequency, performance of protocol biopsies, use of induction therapies and MPA monitoring.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startJun 2007
- Primary completionMay 2010
- Study completionMay 2010
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284257
- Sponsor's protocol ID
- CERL080AUS40
- Acronym
- MORE registry
- Status last verified
- Feb 2017
- First submitted
- 25 Jan 2011
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Non-interventional, Multi-center, Open-label, Prospective, Observational Study of the Safety, Effectiveness, Tolerability and Compliance of Immunosuppressive Regimens Using Mycophenolic Acid to Treat de Novo Renal Transplant Patients in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT01284257
- Acronym / sponsor ID
- MORE registry / CERL080AUS40
- Conditions
- Kidney Transplant
- Keywords
- EC-MPS, MMF, kidney transplant, outcomes, mycophenolate sodium, mycophenolic acid (MPA)
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2007 (actual)
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 26 Jan 2011 (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 MORE Observational Study follows real-world renal transplant patients with the data resolution of a monitored, prospective clinical trial for 5 years. In addition to capturing detailed clinical data, the study describes recent important changes in surveillance testing and drug therapy and relates these changes to short and long-term outcomes. Also, the study measures patient compliance over time and details the rationale for modifications of MPA dosing in maintenance and regimen changes after episodes of AR. The MORE study will provide information on era changes in transplant practices and their impact on clinical outcome, new insights on optimizing regimens for discrete patient subsets and new perspectives on the optimal use of MPA therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteric coated mycophenolate sodium (EC-MPS) arm | – | –Patients to whom EC-MPS is prescribed by their practitioner. |
| MMF arm | – | –Patients to whom MMF is prescribed by their practitioner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll approximately 1,200 de novo (newly transplanted within 2 weeks) renal transplant patients from approximately 30-60 transplant centers across the United States. Patients should be consented prior to the first dose of MPA, +/- 14 days from the date of the transplant and be enrolled as soon as feasible after transplantation but not later than 2 weeks post-transplantation. Enrollment targets will be capped globally at 800 patients being treated with myfortic® and 400 patients being treated with CellCept®.
Key inclusion criteria (5 listed)
- 18 years of age or older.
- The de novo recipient of a cadaveric or living donor kidney transplant, within two weeks of transplantation.
- Receiving mycophenolic acid (MPA) therapy of either myfortic® or CellCept®.
- Able to provide informed consent.
- Able to self-administer the ITAS compliance instrument (6 questions).
Key exclusion criteria (3 listed)
- The recipient of multiple organ grafts or prior non-kidney graft.
- Enrolled or plans to enroll in an investigational clinical trial.
- Not likely to have up to 5 year follow-up data available for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dosage of EC-MPS or MMF over time
Time frame: 60 months
Dosage interruptions, discontinuations and switches between EC-MPS and MMF
4 secondary outcomes
Incidence of Gastro-Intestinal (GI) Adverse Events (AEs) in relationship with prior GI history and GI co-medications
Time frame: 60 months
The incidence of selected Adverse Events
Time frame: 60 months
Combined outcome measure of biopsy-proven acute rejection (BPAR) episodes, graft loss and death
Time frame: 60 months
Center Practices
Time frame: 60 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant, run by Novartis Pharmaceuticals at 8 sites 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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 27 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 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Dosage of EC-MPS or MMF over time (time frame: 60 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 27 Feb 2017.