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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01025817
Other study ID # CRAD001AUS92
Secondary ID
Status Completed
Phase Phase 3
First received November 19, 2009
Last updated October 13, 2015
Start date January 2010
Est. completion date March 2013

Study information

Verified date October 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 613
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion criteria:

- Male or female renal recipients 18-70 years of age undergoing kidney transplantation, either primary or re-transplant;

- Recipient of a cadaveric, deceased donor (including expanded criteria donor organs and deceased donor organs after cardiac death), living unrelated or non-HLA identical living related donor kidney;

- Graft must be functional (producing greater than or equal to 100 ml of urine within 24 hours after transplantation) at time of randomization.

Exclusion criteria:

- Donor organ with a cold ischemic time > 30 hours;

- Males or females who produce less than 100 ml of urine in the first 24 hours post-transplantation;

- Males or females who are recipients of ABO incompatible transplants, or T cell, or B cell crossmatch positive transplant;

- Males or females with severe total hypercholesterolemia or total hypertriglyceridemia (Patients on lipid lowering treatment with controlled hyperlipidemia are acceptable);

- Males or females who have any surgical or any medical condition, such as severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, which in the opinion of the investigator, might alter the absorption, distribution, metabolism and/or excretion of study medication.

Other protocol related inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Everolimus and tacrolimus
Everolimus: Dosage form: 0.75 mg, 0.25 mg, and 0.5 mg tablets Dose: 1.5 mg per day Frequency: 0.75 mg twice daily Tacrolimus: Dose adjusted to maintain specific blood levels
mycophenolate mofetil and tacrolimus
Mycophenolate mofetil: - Dose form: 250 mg capsule - Dose: 2g per day - Frequency: 1g twice daily Tacrolimus: - Dose adjusted to maintain specific blood levels

Locations

Country Name City State
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Montreal Quebec
United States Novartis Investigative Site Ann Arbor Michigan
United States Novartis Investigative Site Aurora Colorado
United States Novartis Investigative Site Baltimore Maryland
United States Novartis Investigative Site Birmingham Alabama
United States Novartis Investigative Site Boston Massachusetts
United States Novartis Investigative Site Buffalo New York
United States Novartis Investigative Site Burlington Vermont
United States Novartis Investigative Site Charleston South Carolina
United States Novartis Investigative Site Charlottesville Virginia
United States Novartis Investigative Site Chicago Illinois
United States Novartis Investigative Site Chicago Illinois
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Detroit Michigan
United States Novartis Investigative Site Detroit Michigan
United States Novartis Investigative Site Durham North Carolina
United States Novartis Investigative Site Fort Worth Texas
United States Novartis Investigative Site Galveston Texas
United States Novartis Investigative Site Greenville North Carolina
United States Novartis Investigative Site Harrisburg Pennsylvania
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Livingston New Jersey
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Lubbock Texas
United States Novartis Investigative Site Miami Florida
United States Novartis Investigative Site Minneapolis Minnesota
United States Novartis Investigative Site Nashville Tennessee
United States Novartis Investigative Site New York New York
United States Novartis Investigative Site Norfolk Virginia
United States Novartis Investigative Site Omaha Nebraska
United States Novartis Investigative Site Orange California
United States Novartis Investigative Site Orlando Florida
United States Novartis Investigative Site Portland Oregon
United States Novartis Investigative Site Richmond Virginia
United States Novartis Investigative Site Royal Oak Michigan
United States Novartis Investigative Site Sacramento California
United States Novartis Investigative Site Salt Lake City Utah
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site San Diego California
United States Novartis Investigative Site San Francisco California
United States Novartis Investigative Site San Francisco California
United States Novartis Investigative Site Seattle Washington
United States Novartis Investigative Site Spokane Washington
United States Novartis Investigative Site St. Louis Missouri
United States Novartis Investigative Site Tampa Florida
United States Novartis Investigative Site Tucson Arizona
United States Novartis Investigative Site Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Incidence of Composite Efficacy Failure Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR)*, (2) graft loss**, (3) participant death or(4) loss to follow-up. *A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. **Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis. 12 Months No
Secondary Estimated Glomerular Filtration Rate (eGFR) Renal function was assessed by estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula. MDRD formula: GFR [mL/min/1.73m^2] = 186.3*(C^-1.154)*(A^-0.203)*G*R. DEFINITIONS: C = serum concentration of creatinine [mg/dL]; A = age [years]; G = 0.742 when gender is female, otherwise G = 1; R = 1.21 when race is black, otherwise R = 1 12 Months No
Secondary Number of Participants With Incidence of CMV (Viremia, Syndrome and Disease) Participants with incidence of CMV (viremia, syndrome and disease). CMV is cytomegalovirus. 12 Months Yes
Secondary Number of Participants With Incidence Rates of BKV Viremia, BKV Viruria, or BKV Nephropathy Participants with Incidence of BKV (viremia, viruria, or nephropathy). BKV is Polyomavirus type BK. 12 Months Yes
Secondary Number of Participants With Incidence of New Onset of Diabetes Mellitus Incidence of new onset diabetes mellitus defined as non-diabetic patients before transplantation, who are receiving glucose lowering treatment for more than 30 days post-transplant, or with a random plasma glucose =200 mg dL (11.1 mmol/L) with 2 fasting plasma glucose values =126 mg/dL (7 mmol/L) 12 Months No
Secondary Number of Participants With Incidence of Proteinuria Events Number of participants with Incidence of proteinuria events indicating chronic kidney disease Baseline and 12 Months No
Secondary Number of Participants With Incidence of Adverse Events, Serious Adverse Events, and Tacrolimus-associated Adverse Events Incidence of adverse events, serious adverse events, and tacrolimus-associated adverse events by System Organ Class 12 Months Yes
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