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12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients

NCT ID: NCT01843348

Last Updated: 2017-05-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

612 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-27

Study Completion Date

2016-03-23

Brief Summary

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This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant recipients.

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Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients

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Detailed Description

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Conditions

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Kidney Transplantation Renal 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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TAC+MPA

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

Capsules: 0.5 mg, 1 mg or 5 mg. Dosing schedule: transplant to month 2: 4-8ng/ml, month 3 to month 12 3-5 ng/ml according to standard blood levels

Enteric Coated Mycophenolate Sodium (EC-MPS)

Intervention Type DRUG

Tablets: 180 mg or 360 mg. Dosing: duration of study 360 mg bid and no less than 360 mg daily dose

Mycophenolate mofetil (MMF)

Intervention Type DRUG

Capsules: 250 or 500 mg. Dosing: duration of study 500 mg bid and no less than 500 mg total daily dose

Corticosteroids

Intervention Type DRUG

A minimum dose of 5 mg prednisolon or equivalent

Simulect

Intervention Type DRUG

Lyophilisate in vials with ampoules of sterile water for injection (5 mL), one vial containing 20 mg lyophilisate given intravenously on the day of transplantation and on day four post-transplantation.

TAC+Certican

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Tacrolimus

Intervention Type DRUG

Capsules: 0.5 mg, 1 mg or 5 mg. Dosing schedule: transplant to month 2: 4-8ng/ml, month 3 to month 12 3-5 ng/ml according to standard blood levels

Corticosteroids

Intervention Type DRUG

A minimum dose of 5 mg prednisolon or equivalent

Simulect

Intervention Type DRUG

Lyophilisate in vials with ampoules of sterile water for injection (5 mL), one vial containing 20 mg lyophilisate given intravenously on the day of transplantation and on day four post-transplantation.

CycA+Certican

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Cyclosporin A

Intervention Type DRUG

Capsules: 10 mg, 25 mg, 50 mg or 100 mg. Transplantation to month 2: 75 - 125 ng/ml, month 3 to month 12: 50 - 100 ng/ml

Corticosteroids

Intervention Type DRUG

A minimum dose of 5 mg prednisolon or equivalent

Simulect

Intervention Type DRUG

Lyophilisate in vials with ampoules of sterile water for injection (5 mL), one vial containing 20 mg lyophilisate given intravenously on the day of transplantation and on day four post-transplantation.

Interventions

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Everolimus

Intervention Type DRUG

Tacrolimus

Capsules: 0.5 mg, 1 mg or 5 mg. Dosing schedule: transplant to month 2: 4-8ng/ml, month 3 to month 12 3-5 ng/ml according to standard blood levels

Intervention Type DRUG

Cyclosporin A

Capsules: 10 mg, 25 mg, 50 mg or 100 mg. Transplantation to month 2: 75 - 125 ng/ml, month 3 to month 12: 50 - 100 ng/ml

Intervention Type DRUG

Enteric Coated Mycophenolate Sodium (EC-MPS)

Tablets: 180 mg or 360 mg. Dosing: duration of study 360 mg bid and no less than 360 mg daily dose

Intervention Type DRUG

Mycophenolate mofetil (MMF)

Capsules: 250 or 500 mg. Dosing: duration of study 500 mg bid and no less than 500 mg total daily dose

Intervention Type DRUG

Corticosteroids

A minimum dose of 5 mg prednisolon or equivalent

Intervention Type DRUG

Simulect

Lyophilisate in vials with ampoules of sterile water for injection (5 mL), one vial containing 20 mg lyophilisate given intravenously on the day of transplantation and on day four post-transplantation.

Intervention Type DRUG

Other Intervention Names

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Certican Basiliximab

Eligibility Criteria

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Inclusion Criteria

* Patient who had received a primary or secondary kidney transplant
* Patients who were willing and from whom written informed consent was obtained
* kidney allograft with a cold ischemia time (CIT) \< 30 hours
* negative pregnancy test prior to study enrollment

Exclusion Criteria

--Multi-organ recipients

* former Graft loss due to immunological reasons
* Patients who received a kidney from a non-heart beating donor
* A-B-0 incompatible transplants
* a current Panel Reactive Antibody (PRA) level of \> 20%
* existing antibodies against the HLA-type of the receiving transplant
* a known hypersensitivity/contraindication to any of the immunosuppressants
* Use of other investigational drugs
* Patients with thrombocytopenia (platelets \< 100,000/mm³), with an absolute neutrophil count of \< 2,000/mm³ or leucopenia (leucocytes \< 3,000/mm³), or hemoglobin \< 8 g/dL
* significant mental illness
* history of malignancy during the last five years
* HIV positive
* uncontrolled hypercholesterolemia or hypertriglyceridemia
* drug or alcohol abuse
* pregnant or breast feeding women
Minimum Eligible Age

18 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

Poitiers, France, France

Site Status

Novartis Investigative Site

Bordeaux, , France

Site Status

Novartis Investigative Site

Brest, , France

Site Status

Novartis Investigative Site

Créteil, , France

Site Status

Novartis Investigative Site

Dijon, , France

Site Status

Novartis Investigative Site

Lille, , France

Site Status

Novartis Investigative Site

Lyon, , France

Site Status

Novartis Investigative Site

Nantes, , France

Site Status

Novartis Investigative Site

Paris, , France

Site Status

Novartis Investigative Site

Saint-Priest-en-Jarez, , France

Site Status

Novartis Investigative Site

Strasbourg, , France

Site Status

Novartis Investigative Site

Toulouse, , France

Site Status

Novartis Investigative Site

Aachen, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Bochum, , Germany

Site Status

Novartis Investigative Site

Dresden, , 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

Freiburg im Breisgau, , 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

Mainz, , Germany

Site Status

Novartis Investigative Site

Münster, , Germany

Site Status

Novartis Investigative Site

Tübingen, , Germany

Site Status

Countries

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France Germany

References

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Philippe A, Arns W, Ditt V, Hauser IA, Thaiss F, Sommerer C, Suwelack B, Dragun D, Hillen J, Schiedel C, Elsasser A, Nashan B. Impact of everolimus plus calcineurin inhibitor on formation of non-HLA antibodies and graft outcomes in kidney transplant recipients: 12-month results from the ATHENA substudy. Front Transplant. 2023 Nov 21;2:1273890. doi: 10.3389/frtra.2023.1273890. eCollection 2023.

Reference Type DERIVED
PMID: 38993854 (View on PubMed)

Sommerer C, Suwelack B, Dragun D, Schenker P, Hauser IA, Nashan B, Thaiss F. Design and rationale of the ATHENA study--A 12-month, multicentre, prospective study evaluating the outcomes of a de novo everolimus-based regimen in combination with reduced cyclosporine or tacrolimus versus a standard regimen in kidney transplant patients: study protocol for a randomised controlled trial. Trials. 2016 Feb 17;17:92. doi: 10.1186/s13063-016-1220-9.

Reference Type DERIVED
PMID: 26888217 (View on PubMed)

Other Identifiers

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2011-005238-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRAD001ADE44

Identifier Type: -

Identifier Source: org_study_id

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