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Completed

NCT Number: NCT01551212

Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients

This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus versus a standard immunosuppressive regimen concerning kidney function in liver transplant recipients.

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Key information

Conditions

Liver Transplantation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Aachen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 < 6g/dl at time of randomization

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

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

Treatment and study plan

Everolimus

Drug

tablet containing 0.25mg, 0.5mg, 0.75mg or 1.0mg

Other names: RAD001 / Certican

Tacrolimus

Drug

capsule containing 0.5, 1.0, or 5.0mg

Other names: Tacrolimus Hexal

Corticosteroids

Drug

For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids may have been used for the duration of the study according to the investigator's discretion, but may not have been eliminated sooner than 6 months post-transplantation.

Primary outcomes

  1. Estimated Glomerular Filtration Rate (GFR)

    Time frame: month 12

    The estmated GFR was calculated using MDRD-4 formula (Modification of Diet in Renal Disease Study Group).

Secondary outcomes

  1. Estimated GFR - PP Set

    Time frame: month 12

    This was a sensitivity analysis for the primary outcome measure based on the per-protocol set of patients.

  2. Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death

    Time frame: 12 months

    Percentage of Participants with Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death at Month 12

  3. Number of Participants With HCV

    Time frame: 12 months

    Number of Participants with HCV (hepatitis C virus) assessed as treatment emergent adverse events of special interest

  4. Incidence of HCV Related Fibrosis

    Time frame: 12 months

    Incidence of hepatitis C virus (HCV) related fibrosis assessed as treatment emergent adverse events of special interest

  5. Incidence of de Novo HCC Malignancies

    Time frame: 12 months

    Incidence of de novo Hepatocellular Carcinoma (HCC) malignancies assessed as treatment emergent adverse events of special interest

  6. Incidence and Severity of CMV Viral Infections.

    Time frame: 12 months

    Incidence and severity of cytomegalovirus (CMV) viral infections assessed as treatment emergent adverse events of special interest.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: HEPHAISTOS

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Mar 12, 2012
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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