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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Novartis
Sponsor:
Collaborator:
CROLLL, Winicker Norimed
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01551212
First received: March 8, 2012
Last updated: August 21, 2014
Last verified: March 2014
  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 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, 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:

Primary Outcome Measures:
  • Estimated glomerular filtration rate (MDRD-4 formula) at Month 12 in de novo liver [ Time Frame: at 12 months after randomization ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Incidence of HCV and HCV related fibrosis [ Time Frame: at 12 months after randomization ] [ Designated as safety issue: No ]
  • Incidence and severity of CMV viral infections. [ Time Frame: at 12 months after randomization ] [ Designated as safety issue: No ]
  • Incidence of de novo HCC malignancies [ Time Frame: at 12 weeks after randomization ] [ Designated as safety issue: No ]
  • Incidence of and response to HCV antiviral treatment [ Time Frame: at 12 months after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: May 2012
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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 <100,000/mm³), with an absolute neutrophil count of <1,500/mm³ or leucopenia (leucocytes <3000/mm³), with anemia with Hb < 8g/dl at time of screening
  • Patients with uncontrolled hypercholesterolemia (>330mg/dL; >9mmol/L) or hypertriglyceridemia (>300 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551212

Locations
Germany
Novartis Investigational Site Recruiting
Berlin, Germany
Contact: Study Director    +41-61-324-1111      
Novartis Investigational Site Recruiting
Essen, Germany
Contact: Study Director    +41-61-324-1111      
Novartis Investigational Site Recruiting
Großhadern, Germany
Contact: Study Director    +41-61-324-1111      
Novartis Investigational Site Recruiting
Hamburg, Germany
Contact: Study Director    +41-61-324-1111      
Novartis Investigational Site Recruiting
Hannover, Germany
Contact: Stduy Director    +41-61-324-1111      
Novartis Investigational Site Active, not recruiting
Leipzig, Germany
Novartis Investigational Site Recruiting
Mainz, Germany
Contact: Study Director    +41-61-324-1111      
Sponsors and Collaborators
Novartis Pharmaceuticals
CROLLL, Winicker Norimed
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01551212     History of Changes
Other Study ID Numbers: CRAD001HDE13, 2011-003118-17
Study First Received: March 8, 2012
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Liver transplantation
everolimus
kidney function

Additional relevant MeSH terms:
Everolimus
Sirolimus
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on September 18, 2014