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Completed Phase 3 Interventional Results available

Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients

ClinicalTrials.gov ID: NCT01025817

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.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 8:46 AM EDT

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
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
613 participants

Conditions and interventions

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
Jan 2010 (Type not available)
Primary completion
Mar 2013 (Actual)
Completion
Mar 2013 (Actual)
Last update posted
Nov 11, 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 11, 2015 · Synced Oct 18, 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 public registry record, listed eligibility criteria, and available contact information for NCT01025817 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →