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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01025817
First received: November 19, 2009
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

The purpose this study is to compare the safety and efficacy of everolimus with low dose tacrolimus to CellCept® (mycophenolate mofetil) with standard dose tacrolimus in kidney transplant patients.


Condition Intervention Phase
Kidney Transplant
Drug: Everolimus and tacrolimus
Drug: CellCept® and tacrolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12 Month, Multi-center, Randomized, Open-label Non-inferiority Study Comparing the Safety and Efficacy of Concentration-controlled Everolimus With Low Dose Tacrolimus to CellCept® (Mycophenolate Mofetil) With Standard Dose Tacrolimus in de Novo Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Composite efficacy failure rates demonstrated by treated biopsy proven acute rejection episodes (BPAR), graft loss, death, loss to follow-up [ Time Frame: Months 6 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare renal function outcome (GFR (glomerular filtration rate)) of everolimus with low dose tacrolimus regimen to that of CellCept® with standard dose tacrolimus regimen [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Incidence of CMV (viremia, syndrome and disease) and BKV (viremia, viruria, or nephropathy) [ Time Frame: Day 28 and Months 2, 3, 4, and 6 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Days 1, 3, 5, 7, 14, and 28 and Months 2, 3, 4, 6, 7, 9, and 12 ] [ Designated as safety issue: No ]
  • Incidence of chronic kidney disease with associated proteinuria [ Time Frame: Days 1, 7, 14, and 28 and Months 2, 3, 4, 6, 7, 9, and 12 ] [ Designated as safety issue: No ]
  • Incidence of adverse events, serious adverse events, and tacrolimus-associated adverse events [ Time Frame: Days 1, 3, 4, 5, 7, 14, and 28 and Months 2, 3, 4, 6, 7, 9, and 12 ] [ Designated as safety issue: Yes ]

Enrollment: 613
Study Start Date: January 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus and low dose tacrolimus 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
Active Comparator: CellCept® and standard dose tacrolimus Drug: CellCept® and tacrolimus

CellCept:

  • Dose form: 250mg capsule
  • Dose: 2g per day
  • Frequency: 1g twice daily

Tacrolimus:

  • Dose adjusted to maintain specific blood levels

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  • Patients who produce less than 100 ml of urine in the first 24 hours post-transplantation;
  • Patients who are recipients of ABO incompatible transplants, or T cell, or B cell crossmatch positive transplant;
  • Patients with severe total hypercholesterolemia or total hypertriglyceridemia (Patients on lipid lowering treatment with controlled hyperlipidemia are acceptable);
  • Patients 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025817

  Show 53 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01025817     History of Changes
Other Study ID Numbers: CRAD001AUS92
Study First Received: November 19, 2009
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Novartis:
Kidney transplant
renal transplant
immunosuppression
mycophenolate mofetil
tacrolimus
everolimus

Additional relevant MeSH terms:
Mycophenolate mofetil
Everolimus
Sirolimus
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 22, 2014