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Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients (HEPHAISTOS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01551212
First Posted: March 12, 2012
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Winicker Norimed GmbH
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This trial will evaluate the efficacy of Everolimus in combination tacrolimus versus a standard immunosuppressive regimen concerning kidney function in liver transplant recipients.

Condition Intervention Phase
Liver Transplantation Drug: Everolimus (RAD001) as add-on Drug: tacrolimus group Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 12-month, Multi-center, Open-label, Randomized, Controlled Study to Evaluate Efficacy/Safety and Evolution of Renal Function of Everolimus in Co-exposure With Tacrolimus in de Novo Liver Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Eestimated glomerular filtration rate (MDRD-4 formula) at Month 12 in de novo liver [ Time Frame: at 12 months after randomization ]
    Immunosuppressive regimen based on everolimus (EVR) in coexposure with tacrolimus (TAC) compared to tacrolimus alone on estimated glomerular filtration rate (MDRD-4 formula) at Month 12 in de novo liver transplant recipients.


Secondary Outcome Measures:
  • Incidence of composite of treated biopsy proven acute rejection (BPAR), graft loss or death [ Time Frame: 12 months after randomization ]
  • Incidence of HCV and HCV related fibrosis [ Time Frame: at 12 months after randomization ]
  • Incidence and severity of CMV viral infections. [ Time Frame: at 12 months after randomization ]
  • Incidence of de novo HCC malignancies [ Time Frame: at 12 weeks after randomization ]
  • Incidence of and response to HCV antiviral treatment [ Time Frame: at 12 months after randomization ]

Enrollment: 333
Actual Study Start Date: May 24, 2012
Study Completion Date: August 8, 2017
Primary Completion Date: August 8, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: tacrolimus group
standby therapy
Drug: tacrolimus group
Experimental: tacrolimus minimization group
Everolimus (RAD001) as add-on
Drug: Everolimus (RAD001) as add-on

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Male or female recipients of a full-size liver allograft, aged 18 to 65 years.

Exclusion criteria:

Patients with thrombocytopenia (platelets <50,000/mm³), with an absolute neutrophil count of <1,000/mm³ or leucopenia (leucocytes <2000/mm³), with anemia with Hb < 8g/dl at time of screening

Patients with uncontrolled hypercholesterolemia (>350mg/dL; >9mmol/L) or hypertriglyceridemia (>750 mg/dL; >8.5 mmol/L) at time of screening

History of malignancy of any organ system within the past 5 years whether or not there is evidence of local recurrence or metastases, other than non-metastatic basal or squamous cell carcinoma of the skin or HCC (see next criteria).

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551212


Locations
Germany
Novartis Investigative Site
Aachen, Germany, 52074
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Bonn, Germany, 53105
Novartis Investigative Site
Erlangen, Germany, 91052
Novartis Investigative Site
Essen, Germany, 45147
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Hamburg, Germany, 20246
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Kiel, Germany, 24105
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Munchen, Germany, 81377
Novartis Investigative Site
Regensburg, Germany, 93053
Novartis Investigative Site
Tübingen, Germany, 72076
Sponsors and Collaborators
Novartis Pharmaceuticals
Winicker Norimed GmbH
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01551212     History of Changes
Other Study ID Numbers: CRAD001HDE13
2011-003118-17 ( EudraCT Number )
First Submitted: March 8, 2012
First Posted: March 12, 2012
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Liver transplantation
everolimus
kidney function

Additional relevant MeSH terms:
Everolimus
Sirolimus
Tacrolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action