Kidney TransplantationPhase 3NCT00101738
Freedom Study: Myfortic in Kidney Transplant Patients
A Phase 3 study testing Myfortic in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 44 sites in 13 countries.
Trial summary
The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Myfortic
- How many people
- 342 participants
- Where
- 44 sitesin 13 countries
- Study dates
- Mar 2003to May 2005
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18 to 75 years.
- Recipients of first, heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with Simulect® and Neoral® as primary immunosuppression.
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 non-heart beating donors or HLA identical living related donors.
- ABO incompatibility against the donor.
Trial locations and contacts
44 sites in 13 countries.
44 sites in 13 countries
United States9 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
University Hospitals of Cleveland, Division of Nephrology
Cleveland, Ohio, 44106
Ohio State University Medical Center
Columbus, Ohio, 43210
Indiana U. Medical Center
Indianapolis, Indiana, 46202
U. of Wisconsin Hospital Clinics
Madison, Wisconsin, 53792-7375
Loyola Medical Center
Maywood, Illinois, 60153
Legacy Research & Technology Ctr.
Portland, Oregon, 97232
UCSF Kidney Transplant Service
San Francisco, California, 94143-0780
Livelink, Inc.
Tampa, Florida, 33606
Canada7 sites
Foothills Medical Center
Calgary, Alberta, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Queen II Health and Science Center
Halifax, Nova Scotia, B3H 2Y6
McGill University Health Centre
Montreal, Quebec, H3A 1A1
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
St. Michael's Hospital
Toronto, Ontario, M5C 2T2
University Health Network, The Toronto Hospital
Toronto, Ontario, M5G 2C4
United Kingdom6 sites
Queen Elizabeth Medical Centre
Edgbaston, Birmingham, B15 2TH
University Hospital of Wales
Heathpark, Cardiff, CF14 4XW
Freeman Hospital
High Heaton, Newcastle Upon Tyne, NE7 7DN
Guy's Hospital
London, SE1 9RT
Nottingham City Hospital
Nottingham, NG5 1BP
Walsgrave Hospital NHS Trust
Walsgrave on Sowe, Coventry, CV2 2DX
Australia5 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Monash Medical Centre
Clayton, Victoria, 3168
Royal Melbourne Hospital
Parkville, Victoria, 3052
The Queen Elizabeth Hospital
Woodville, South Australia, 5011
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Argentina3 sites
Hospital Cordoba
Córdoba, Córdoba Province, 5000
Unidad de Transplante Velez Sarsfield
Córdoba, Córdoba Province, X5016JDA
Crai Norte
San Martín, Buenos Aires, 1650
Spain3 sites
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907
Hospital Clinico San Carlos
Madrid, Madrid, 28040
Hospital Central de Asturias
Oviedo, Oviedo, 33006
Taiwan3 sites
Taipei Veterans General Hospital
Taipei, ROC
National Taiwan University Hospital
Taipei, 100
Chang-Gung Memorial Hospital-Linko
Taoyuan, Lin-Ko, 333
Brazil2 sites
Hospital das Clinicas - UNICAMP
Campinas, São Paulo, 13083-970
Hipertensao Hospital do Rim e Hipertensao
São Paulo, São Paulo, 04023 900
Germany2 sites
Staedt. Krankenhaus Koeln-Merheim
Cologne, 51109
Klinikum der Johann Wolfgang Geothe-Universitaet
Frankfurt am Main, 60596
Italy1 site
Ospedale Consorziale e policlinico-Universita degli Studi
Bari, BA, 70124
About this study
Official title: Study to Investigate the Clinical Outcomes of Different Regimens of Myfortic® in De Novo Kidney Tx Pts Using Simulect® and Neoral® With or Without Steroids
The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.
- Conditions
- Kidney Transplantation
- Being tested
- Myfortic
- Keywords
- MPA, Kidney Transplantation, Acute rejection, Kidney function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyforticDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculated glomerular filtration rate after 12 months treatment
Secondary outcomes (5)
Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months.
Patient and graft survival after 12 months.
Incidence of AEs and SAEs after 3 and 12 months.
Blood pressure, lipids and glucose profiles after 3 and 12 months.
Percentage of patients free of steroids at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2005 (estimated)
- Study startMar 2003
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 342 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
- NCT00101738
- Sponsor's protocol ID
- CERL080A2404
- Status last verified
- Jan 2011
- First submitted
- 12 Jan 2005
- Last updated
- 31 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Clinical Outcomes of Different Regimens of Myfortic® in De Novo Kidney Tx Pts Using Simulect® and Neoral® With or Without Steroids
- ClinicalTrials.gov ID
- NCT00101738
- Acronym / sponsor ID
- CERL080A2404
- Conditions
- Kidney Transplantation
- Keywords
- MPA, Kidney Transplantation, Acute rejection, Kidney function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 13 Jan 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 primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females aged 18 to 75 years.
- Recipients of first, heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with Simulect® and Neoral® as primary immunosuppression.
Key exclusion criteria (3 listed)
- Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ.
- Kidneys from non-heart beating donors or HLA identical living related donors.
- ABO incompatibility against the donor.
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 |
|---|---|---|
| Myfortic | Drug | – |
Primary outcome
Calculated glomerular filtration rate after 12 months treatment
5 secondary outcomes
Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months.
Patient and graft survival after 12 months.
Incidence of AEs and SAEs after 3 and 12 months.
Blood pressure, lipids and glucose profiles after 3 and 12 months.
Percentage of patients free of steroids at 12 months
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 31 Jan 2011.
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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
44 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Myfortic in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 44 sites in 13 countries.
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 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: finished, as of the sponsor's last update on 31 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Canada, United Kingdom, Australia, Argentina and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Calculated glomerular filtration rate after 12 months treatment. 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 31 Jan 2011.