Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients (HEPHAISTOS)
This study is currently recruiting participants.
Verified January 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Collaborator:
CROLLL, Winicker Norimed
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01551212
First received: March 8, 2012
Last updated: January 15, 2013
Last verified: January 2013
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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: | April 2015 (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
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 | Not yet recruiting |
| Hannover, Germany | |
| Contact: Stduy Director +41-61-324-1111 | |
| Novartis Investigational Site | Not yet recruiting |
| Leipzig, Germany | |
| Contact: Study Director +41-61-324-1111 | |
| 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: | January 15, 2013 |
| 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 |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013