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SCHEDULE Follow Up Visit 5-7 yr

NCT ID: NCT02864706

Last Updated: 2019-10-03

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-18

Study Completion Date

2017-09-25

Brief Summary

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The major aim of this extension study was to evaluate the long-term effect (i.e. 5 to 7 years) of early initiation of everolimus and early elimination of CsA compared to standard immunosuppressive regimen including CsA on primary and secondary endpoints investigated in the SCHEDULE (NCT01266148) main study.

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SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance

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Everolimus in de Novo Heart Transplant Recipients

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Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients

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This is a Two-year Follow-up Study to Evaluate the Long-term Safety, Tolerability and Efficacy of 2 Different Doses of Everolimus

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A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients

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Heart Transplantation
COMPLETED PHASE4

Detailed Description

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This protocol was written to describe the procedures for a single 5, 6 or 7 year follow-up control visit of patients who participated in the 12-month SCHEDULE (NCT01266148) study and the following 3-year follow-up examination/visit. The aim of this 5 to 7-year follow-up visit was to examine the effect of long term treatment, i.e. 5, 6 or 7 years, with early initiation of everolimus (Certican®) and early elimination of cyclosporine (CsA), compared to standard immunosuppressive regimen including CsA, on renal and heart function. During the time period of this follow-up examinations, this visit was performed as part of a routine annual visit 5, 6 or 7 years since transplantation (and inclusion in the original SCHEDULE study).

Study code of SCHEDULE, the core study: CRAD001ANO02 (EudraCT No.: 2009-013074-41)

Conditions

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Heart Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EVEROLIMUS

patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

All patients, independent of their initial randomization in the core study, were followed up as in one single group

Commercially available everolimus (Certican®), oral route, was used.

Control

patients received standard CsA, MMF and corticosteroids

Group Type ACTIVE_COMPARATOR

Cyclosporine

Intervention Type DRUG

Cyclosporine (CsA) control group target blood level: 150-350 ng/mL (month 1-3); 100-250 ng/mL (month 4-6); 60-200 ng/mL (month 7-12); everolimus group target blood level: 75-175 ng/mL (month 1-3)

Mycophenolate mofetil

Intervention Type DRUG

Mycophenolate mofetil (MMF) target dose for control group: 2000-3000 mg/day everolimus group target dose: 1500-2000 mg/day and 75-175 ng/mL after week 11

Corticosteroids

Intervention Type DRUG

Corticosteroids (CS) initiated at 0.2-0.5 mg/kg/day. Tapered to no less than 0.1 mg/kg at Month 3 for control and everolimus groups.

Interventions

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Everolimus

All patients, independent of their initial randomization in the core study, were followed up as in one single group

Commercially available everolimus (Certican®), oral route, was used.

Intervention Type DRUG

Cyclosporine

Cyclosporine (CsA) control group target blood level: 150-350 ng/mL (month 1-3); 100-250 ng/mL (month 4-6); 60-200 ng/mL (month 7-12); everolimus group target blood level: 75-175 ng/mL (month 1-3)

Intervention Type DRUG

Mycophenolate mofetil

Mycophenolate mofetil (MMF) target dose for control group: 2000-3000 mg/day everolimus group target dose: 1500-2000 mg/day and 75-175 ng/mL after week 11

Intervention Type DRUG

Corticosteroids

Corticosteroids (CS) initiated at 0.2-0.5 mg/kg/day. Tapered to no less than 0.1 mg/kg at Month 3 for control and everolimus groups.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who participated in the SCHEDULE 12-month main study, and who completed the 3 year follow-up visit
* Patients who are coming for a regular annual clinic visit 5 to 7 years after randomization in the main study
* Obtaining of a separate signed patient informed consent will be required for participation in this follow-up examination.

Exclusion Criteria

* Patients with a retransplanted heart since the original SCHEDULE study
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

Århus N, , Denmark

Site Status

Novartis Investigative Site

Copenhagen, , Denmark

Site Status

Novartis Investigative Site

Oslo, , Norway

Site Status

Novartis Investigative Site

Gothenburg, , Sweden

Site Status

Novartis Investigative Site

Linköping, , Sweden

Site Status

Novartis Investigative Site

Lund, , Sweden

Site Status

Countries

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Denmark Norway Sweden

References

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Andreassen AK, Andersson B, Gustafsson F, Eiskjaer H, Radegran G, Gude E, Jansson K, Solbu D, Karason K, Arora S, Dellgren G, Gullestad L; SCHEDULE investigators. Everolimus Initiation With Early Calcineurin Inhibitor Withdrawal in De Novo Heart Transplant Recipients: Three-Year Results From the Randomized SCHEDULE Study. Am J Transplant. 2016 Apr;16(4):1238-47. doi: 10.1111/ajt.13588. Epub 2016 Jan 28.

Reference Type BACKGROUND
PMID: 26820618 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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CRAD001ANO026YFU

Identifier Type: OTHER

Identifier Source: secondary_id

2016-000404-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRAD001ANO05

Identifier Type: -

Identifier Source: org_study_id

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