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Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients

NCT ID: NCT01551212

Last Updated: 2019-05-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

339 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-24

Study Completion Date

2017-08-08

Brief Summary

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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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A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus

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Detailed Description

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Conditions

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Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EVR/TAC

Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \< 5 ng/mL)

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

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

Tacrolimus

Intervention Type DRUG

capsule containing 0.5, 1.0, or 5.0mg

Corticosteroids

Intervention Type 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.

TAC

Tacrolimus (C0-h: 6-10 ng/ml)

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

capsule containing 0.5, 1.0, or 5.0mg

Corticosteroids

Intervention Type 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.

Interventions

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Everolimus

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

Intervention Type DRUG

Tacrolimus

capsule containing 0.5, 1.0, or 5.0mg

Intervention Type DRUG

Corticosteroids

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.

Intervention Type DRUG

Other Intervention Names

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RAD001 / Certican Tacrolimus Hexal

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Aachen, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Bonn, , Germany

Site Status

Novartis Investigative Site

Erlangen, , Germany

Site Status

Novartis Investigative Site

Essen, , Germany

Site Status

Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Heidelberg, , Germany

Site Status

Novartis Investigative Site

Kiel, , Germany

Site Status

Novartis Investigative Site

Leipzig, , Germany

Site Status

Novartis Investigative Site

Mainz, , Germany

Site Status

Novartis Investigative Site

München, , Germany

Site Status

Novartis Investigative Site

Regensburg, , Germany

Site Status

Novartis Investigative Site

Tübingen, , Germany

Site Status

Countries

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Germany

References

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Nashan B, Schemmer P, Braun F, Schlitt HJ, Pascher A, Klein CG, Neumann UP, Kroeger I, Wimmer P; Hephaistos Study Group. Early Everolimus-Facilitated Reduced Tacrolimus in Liver Transplantation: Results From the Randomized HEPHAISTOS Trial. Liver Transpl. 2022 Jun;28(6):998-1010. doi: 10.1002/lt.26298. Epub 2021 Oct 12.

Reference Type DERIVED
PMID: 34525259 (View on PubMed)

Nashan B, Schemmer P, Braun F, Dworak M, Wimmer P, Schlitt H. Evaluating the efficacy, safety and evolution of renal function with early initiation of everolimus-facilitated tacrolimus reduction in de novo liver transplant recipients: Study protocol for a randomized controlled trial. Trials. 2015 Mar 26;16:118. doi: 10.1186/s13063-015-0626-0.

Reference Type DERIVED
PMID: 25873064 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2011-003118-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRAD001HDE13

Identifier Type: -

Identifier Source: org_study_id

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