Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients
Public ClinicalTrials.gov record NCT01025817. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 12 Month, Multi-center, Randomized, Open-label Non-inferiority Study Comparing Safety and Efficacy of Concentration-controlled Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in de Novo Renal Transplant Recipients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.
Study identification
- NCT ID
- NCT01025817
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 613 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2009
- Primary completion
- Feb 28, 2013
- Completion
- Feb 28, 2013
- Last update posted
- Nov 10, 2015
2010 – 2013
United States locations
- U.S. sites
- 48
- U.S. states
- 24
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35233 | — |
| Novartis Investigative Site | Tucson | Arizona | 85742-5022 | — |
| Novartis Investigative Site | Los Angeles | California | 90033 | — |
| Novartis Investigative Site | Los Angeles | California | 90048 | — |
| Novartis Investigative Site | Los Angeles | California | 90095 | — |
| Novartis Investigative Site | Orange | California | 92868 | — |
| Novartis Investigative Site | Sacramento | California | 95817 | — |
| Novartis Investigative Site | San Diego | California | 92103 | — |
| Novartis Investigative Site | San Diego | California | 92123 | — |
| Novartis Investigative Site | San Francisco | California | 94115 | — |
| Novartis Investigative Site | San Francisco | California | 94143-0780 | — |
| Novartis Investigative Site | Aurora | Colorado | 80045 | — |
| Novartis Investigative Site | Miami | Florida | 33136 | — |
| Novartis Investigative Site | Orlando | Florida | 32804 | — |
| Novartis Investigative Site | Tampa | Florida | 33606 | — |
| Novartis Investigative Site | Chicago | Illinois | 60612 | — |
| Novartis Investigative Site | Chicago | Illinois | 60637 | — |
| Novartis Investigative Site | Baltimore | Maryland | 21201 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02111 | — |
| Novartis Investigative Site | Worcester | Massachusetts | 01655 | — |
| Novartis Investigative Site | Ann Arbor | Michigan | 48109-0331 | — |
| Novartis Investigative Site | Detroit | Michigan | 48202-2689 | — |
| Novartis Investigative Site | Detroit | Michigan | 48236 | — |
| Novartis Investigative Site | Royal Oak | Michigan | 48073 | — |
| Novartis Investigative Site | Minneapolis | Minnesota | 55455 | — |
| Novartis Investigative Site | St Louis | Missouri | 63110 | — |
| Novartis Investigative Site | Omaha | Nebraska | 68198-3285 | — |
| Novartis Investigative Site | Livingston | New Jersey | 07039 | — |
| Novartis Investigative Site | Buffalo | New York | 14215 | — |
| Novartis Investigative Site | New York | New York | 10032 | — |
| Novartis Investigative Site | Durham | North Carolina | 27710 | — |
| Novartis Investigative Site | Greenville | North Carolina | 27834 | — |
| Novartis Investigative Site | Portland | Oregon | 97239 | — |
| Novartis Investigative Site | Harrisburg | Pennsylvania | 17105-8700 | — |
| Novartis Investigative Site | Charleston | South Carolina | 29425 | — |
| Novartis Investigative Site | Nashville | Tennessee | 37212-3139 | — |
| Novartis Investigative Site | Dallas | Texas | 75246 | — |
| Novartis Investigative Site | Fort Worth | Texas | 76104 | — |
| Novartis Investigative Site | Galveston | Texas | 77555-0144 | — |
| Novartis Investigative Site | Houston | Texas | 77030 | — |
| Novartis Investigative Site | Lubbock | Texas | 79430 | — |
| Novartis Investigative Site | Salt Lake City | Utah | 84132 | — |
| Novartis Investigative Site | Burlington | Vermont | 05401 | — |
| Novartis Investigative Site | Charlottesville | Virginia | 22908 | — |
| Novartis Investigative Site | Norfolk | Virginia | 23507 | — |
| Novartis Investigative Site | Richmond | Virginia | 23298 | — |
| Novartis Investigative Site | Seattle | Washington | 98195 | — |
| Novartis Investigative Site | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01025817, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 10, 2015 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01025817 live on ClinicalTrials.gov.