Organ TransplantationNCT00149981
A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation
A study testing everolimus (RAD) in people with Organ Transplantation, run by Novartis Pharmaceuticals at 153 sites in 19 countries.
Trial summary
Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Transplantation
- What is being tested?
- everolimus (RAD)
- How many people
- Not given
- Where
- 153 sitesin 19 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
Who may be able to join
- Male or female recipients of solid organ transplants
- Subject is currently enrolled in an everolimus (RAD) trial sponsored by Novartis
- Currently on investigational drug everolimus (RAD) therapy
Who cannot join
- Inability or unwillingness to comply with immunosuppressive regimen.
- Pregnancy.
- History of acute organ rejection within the last 3 months.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
153 sites in 19 countries.
153 sites in 19 countries
United States68 sites
Novartis Investigative Site
Albany, New York, 12208
Novartis Investigative Site
Ann Arbor, Michigan, 48109-0331
Novartis Investigative Site
Atlanta, Georgia, 30309
Novartis Investigative Site
Atlanta, Georgia, 30322
Novartis Investigative Site
Augusta, Georgia, 30912-3140
Novartis Investigative Site
Aurora, Colorado, 80045
Novartis Investigative Site
Baltimore, Maryland, 21287
Novartis Investigative Site
Birmingham, Alabama, 35233
Novartis Investigative Site
Birmingham, Alabama, 35294-0006
Novartis Investigative Site
Boston, Massachusetts, 02111
Novartis Investigative Site
Buffalo, New York, 14203
Novartis Investigative Site
Charleston, South Carolina, 29403
Novartis Investigative Site
Charleston, South Carolina, 29425
Novartis Investigative Site
Charleston, West Virginia, 25301
Novartis Investigative Site
Charlottesville, Virginia, 22908
Novartis Investigative Site
Chicago, Illinois, 60612
Novartis Investigative Site
Chicago, Illinois, 60637
Novartis Investigative Site
Cleveland, Ohio, 44106-5048
Novartis Investigative Site
Cleveland, Ohio, 44195
Novartis Investigative Site
Columbus, Ohio, 43205-2696
Novartis Investigative Site
Columbus, Ohio, 43210
Novartis Investigative Site
Dallas, Texas, 75246
Novartis Investigative Site
Denver, Colorado, 80218
Novartis Investigative Site
Des Moines, Iowa, 50309
Novartis Investigative Site
Durham, North Carolina, 27710
Novartis Investigative Site
Fargo, North Dakota, 58122
Novartis Investigative Site
Gainesville, Florida, 32610-0277
Novartis Investigative Site
Galveston, Texas, 77555-0144
Novartis Investigative Site
Greenville, North Carolina, 27834
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Lexington, Kentucky, 40536-0293
Novartis Investigative Site
Livingston, New Jersey, 07039
Novartis Investigative Site
Los Angeles, California, 90024
Novartis Investigative Site
Los Angeles, California, 90027
Novartis Investigative Site
Los Angeles, California, 90048
Novartis Investigative Site
Los Angeles, California, 90057
Novartis Investigative Site
Los Angeles, California, 90095
Novartis Investigative Site
Madison, Wisconsin, 53792
Novartis Investigative Site
Maywood, Illinois, 60153
Novartis Investigative Site
Milwaukee, Wisconsin, 53215
Novartis Investigative Site
Mobile, Alabama, 36617
Novartis Investigative Site
Murray, Utah, 84157
Novartis Investigative Site
Nashville, Tennessee, 37212
Novartis Investigative Site
New Brunswick, New Jersey, 08901
Novartis Investigative Site
New Haven, Connecticut, 06510
Novartis Investigative Site
New Orleans, Louisiana, 70112
Novartis Investigative Site
New Orleans, Louisiana, 70121
Novartis Investigative Site
New York, New York, 10032
Novartis Investigative Site
Norfolk, Virginia, 23507
Novartis Investigative Site
Omaha, Nebraska, 68198
Novartis Investigative Site
Philadelphia, Pennsylvania, 19102 2293
Novartis Investigative Site
Philadelphia, Pennsylvania, 19104
Novartis Investigative Site
Philadelphia, Pennsylvania, 19140
Novartis Investigative Site
Providence, Rhode Island, 02903
Novartis Investigative Site
Richmond, Virginia, 23284
Novartis Investigative Site
Salt Lake City, Utah, 84132
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
San Diego, California, 92103-8745
Novartis Investigative Site
San Francisco, California, 94115
Novartis Investigative Site
Shreveport, Louisiana, 71103
Novartis Investigative Site
St Louis, Missouri, 63104-1314
Novartis Investigative Site
St Louis, Missouri, 63110
Novartis Investigative Site
Stanford, California, 94304
Novartis Investigative Site
Tampa, Florida, 33606
Novartis Investigative Site
The Bronx, New York, 10467
Novartis Investigative Site
Valhalla, New York, 10595
Novartis Investigative Site
Winston-Salem, North Carolina, 27157
Novartis Investigative Site
Worcester, Massachusetts, 01655
France14 sites
Novartis Investigative Site
Brest, 29200
Novartis Investigative Site
Créteil, 94010
Novartis Investigative Site
Grenoble, 38000
Novartis Investigative Site
Le Plessis-Robinson, 92350
Novartis Investigative Site
Lyon, 69437
Novartis Investigative Site
Monpellier, 34295
Novartis Investigative Site
Nantes, 44035
Novartis Investigative Site
Paris, 75010
Novartis Investigative Site
Paris, 75651
Novartis Investigative Site
Saint-Etienne, 42055
Novartis Investigative Site
Toulouse, 31054
Novartis Investigative Site
Tours, 37044
Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511
Novartis Investigative Site
Villejuif, 94800
Canada11 sites
Novartis Investigative Site
Edmonton, Alberta, T6G 2B7
Novartis Investigative Site
Halifax, Nova Scotia, B3H 2Y6
Novartis Investigative Site
Hamilton, Ontario, L8N 4A6
Novartis Investigative Site
London, Ontario, N6A 5A5
Novartis Investigative Site
Montreal, Quebec, H2L 4M1
Novartis Investigative Site
Montreal, Quebec, H3A 1A1
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4G5
Novartis Investigative Site
Saskatoon, Saskatchewan, S7N 0W8
Novartis Investigative Site
Toronto, Ontario, M5C 2T2
Novartis Investigative Site
Toronto, Ontario, M5G 2C4
Novartis Investigative Site
Vancouver, British Columbia, V6Z 1Y6
Italy11 sites
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Milan, MI, 20162
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Parma, PR, 43100
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Perugia, PG, 06100
Novartis Investigative Site
Pisa, PI, 56124
Novartis Investigative Site
Roma, RM, 00168
Novartis Investigative Site
Sassari, SS, 07100
Novartis Investigative Site
Siena, SI, 53100
Novartis Investigative Site
Vicenza, VI, 36100
Spain10 sites
Novartis Investigative Site
Barakaldo, Vizcaya, 48903
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Córdoba, Andalusia, 14004
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Madrid, 28222
Novartis Investigative Site
Santander, Cantabria, 39008
Novartis Investigative Site
Valencia, Valencia, 46026
Germany6 sites
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Hanover, 30625
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Regensburg, Bavaria, 93053
Australia5 sites
Novartis Investigative Site
Camperdown, New South Wales, 2050
Novartis Investigative Site
Clayton, Victoria, 3168
Novartis Investigative Site
Darlinghurst, New South Wales, 2010
Novartis Investigative Site
Parkville, Victoria, 3052
Novartis Investigative Site
Woolloongabba, Queensland, 4102
Taiwan5 sites
Novartis Investigative Site
Taichung, Taiwan ROC, 40201
Novartis Investigative Site
Taichung, 40705
Novartis Investigative Site
Tainan, Taiwan ROC, 70403
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taoyuan, 33305
Brazil4 sites
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30110-934
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90020-090
Novartis Investigative Site
São Paulo, São Paulo, 04023-900
Novartis Investigative Site
São Paulo, São Paulo, 05403-000
Czechia4 sites
Novartis Investigative Site
Brno, 656 91
Novartis Investigative Site
Hradec Králové, 505 00
Novartis Investigative Site
Ostrava-Poruba, 708 52
Novartis Investigative Site
Prague, 140 21
United Kingdom4 sites
Novartis Investigative Site
London, E1 1BB
Novartis Investigative Site
London, SE1 9RT
Novartis Investigative Site
Manchester, M23 9LT
Novartis Investigative Site
Salford, M6 8HD
Belgium3 sites
Novartis Investigative Site
Brussels, 1070
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Leuven, 3000
Switzerland2 sites
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Zurich, 8091
About this study
Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties
Read the detailed description
This is a treatment protocol designed only to provide access to everolimus (RAD) for maintenance immunosuppression. The objectives are to facilitate the management of patients on maintenance immunosuppression therapy who are completing everolimus trials,
- To provide everolimus maintenance therapy through this access program and
- To collect and review safety data for up to 120 months or until the project has been discontinued whichever comes first.
- To collect and review safety data for up to 120 months or when Certican is commercially available in the given indication and reimbursed by appropriate payors or the project has been discontinued whichever comes first.
- Conditions
- Organ Transplantation
- Being tested
- everolimus (RAD)
- Keywords
- Kidney, heart, lung, liver, pancreas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimus (RAD)Drug
Everolimus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149981
- Sponsor's protocol ID
- CRAD001A2401
- Other IDs
- 2004-001473-25, 2004
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2005
- Last updated
- 9 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation
- ClinicalTrials.gov ID
- NCT00149981
- Acronym / sponsor ID
- CRAD001A2401
- Conditions
- Organ Transplantation
- Keywords
- Kidney, heart, lung, liver, pancreas
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 8 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.
Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties
Detailed description
This is a treatment protocol designed only to provide access to everolimus (RAD) for maintenance immunosuppression. The objectives are to facilitate the management of patients on maintenance immunosuppression therapy who are completing everolimus trials,
- To provide everolimus maintenance therapy through this access program and
- To collect and review safety data for up to 120 months or until the project has been discontinued whichever comes first.
- To collect and review safety data for up to 120 months or when Certican is commercially available in the given indication and reimbursed by appropriate payors or the project has been discontinued whichever comes first.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female recipients of solid organ transplants
- Subject is currently enrolled in an everolimus (RAD) trial sponsored by Novartis
- Currently on investigational drug everolimus (RAD) therapy
Key exclusion criteria (4 listed)
- Inability or unwillingness to comply with immunosuppressive regimen.
- Pregnancy.
- History of acute organ rejection within the last 3 months.
- Other protocol-defined 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 |
|---|---|---|
| everolimus (RAD)Everolimus | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
Related trials for Organ Transplantation
RecruitingPhase 1
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Recruiting
In-situ vs Ex-situ Liver Preservation
Liver Disease (Alcoholic or Not), Transplantation
Not yet recruiting
Improving Deceased Organ Donation and Transplantation Using the Donation Advisor Clinical Decision Support Tool
Organ Donation After Circulatory Death, Organ Donation
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
RecruitingPhase 2
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
Immunization; Infection, Transplantation Infection
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 Pharmaceuticals study director
Novartis Pharmaceuticals
153 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing everolimus (RAD) in people with Organ Transplantation, run by Novartis Pharmaceuticals at 153 sites in 19 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 3 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: status not confirmed, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 153 sites in United States, France, Canada, Italy, Spain and 14 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.
Are results available for this study?
Results are not available in the source record.
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.
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 9 Sep 2019.