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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 21, 2014
Last verified: October 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 4

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:
  • Eestimated 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: January 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 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 <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
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

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Germany
Novartis Investigative Site Recruiting
Aachen, Germany, 52074
Novartis Investigative Site Recruiting
Berlin, Germany, 13353
Novartis Investigative Site Recruiting
Bonn, Germany, 53105
Novartis Investigative Site Recruiting
Erlangen, Germany, 91052
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Frankfurt, Germany, 60590
Novartis Investigative Site Recruiting
Hamburg, Germany, 20246
Novartis Investigative Site Recruiting
Hannover, Germany, 30625
Novartis Investigative Site Recruiting
Heidelberg, Germany, 69120
Novartis Investigative Site Recruiting
Kiel, Germany, 24105
Novartis Investigative Site Recruiting
Leipzig, Germany, 04103
Novartis Investigative Site Recruiting
Mainz, Germany, 55131
Novartis Investigative Site Withdrawn
München, Germany, 81675
Novartis Investigative Site Recruiting
München, Germany, 81377
Novartis Investigative Site Recruiting
Regensburg, Germany, 93053
Novartis Investigative Site Recruiting
Tübingen, Germany, 72076
Sponsors and Collaborators
Novartis Pharmaceuticals
CROLLL, Winicker Norimed
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  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: October 21, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Liver transplantation
everolimus
kidney function

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

ClinicalTrials.gov processed this record on October 22, 2014