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Heart TransplantationPhase 4CRAD001ANO05NCT02864706

SCHEDULE Follow Up Visit 5-7 yr

A Phase 4 study testing Everolimus, Cyclosporine and Mycophenolate mofetil in people with Heart Transplantation, run by Novartis Pharmaceuticals at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Heart Transplantation
What is being tested?
Everolimus, Cyclosporine and Mycophenolate mofetil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
6 sitesin 3 countries
Study dates
18 Jan 2016to 25 Sep 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Patients with a retransplanted heart since the original SCHEDULE study

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

Sweden3 sites

  • Novartis Investigative Site

    Gothenburg, 413 45

  • Novartis Investigative Site

    Linköping, 581 85

  • Novartis Investigative Site

    Lund, 221 85

Other trials in Sweden

Denmark2 sites

  • Novartis Investigative Site

    Århus N, DK-8200

  • Novartis Investigative Site

    Copenhagen, DK-2100

Other trials in Denmark

Norway1 site

  • Novartis Investigative Site

    Oslo, 0372

Other trials in Norway

About this study

Official title: 5, 6 or 7 Year Follow-up Control After the SCHEDULE Study (SCANDINAVIAN HEART TRANSPLANT EVEROLIMUS DE NOVO STUDY WITH EARLY CNI AVOIDANCE)

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.

Read the detailed description

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)

Being tested
Everolimus, Cyclosporine, Mycophenolate mofetil, Corticosteroids
Keywords
allograft rejection, xenograft rejection, host vs graft disease, transplant
Medical subject headings
Graft vs Host Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EverolimusDrug

    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.

  • CyclosporineDrug

    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 mofetilDrug

    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

  • CorticosteroidsDrug

    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.

Study groups in NCT02864706
Study groupRoleWhat they receive
EVEROLIMUSExperimentalpatients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks
Receives: Drug: Everolimus
ControlActive comparatorpatients received standard CsA, MMF and corticosteroids
Receives: Drug: Cyclosporine; Drug: Mycophenolate mofetil; Drug: Corticosteroids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measured Glomerular Filtration Rate (mGFR)

    Renal function as assessed by measured Glomerular Filtration Rate (mGFR) (Cr-EDTA or iohexol clearance). Baseline Visit 1 and Patient 4252 excluded from the intent treat analysis set.

    Measured: at the 5-7 year follow-up visit

Secondary outcomes (7)

  1. Progression of Cardiac Allograft Vasculopathy (CAV) Recorded by Intravascular Ultrasound (IVUS)

    Cardiac Allograft Vasculopathy (CAV) was defined as mean maximal intimal thickness (MIT)

    ≥0.5 mm, measured for the entire matched pullback recording by intravascular ultrasound (IVUS). The incidence of CAV at 5-7 years was compared between groups using the Cochran-Mantel-Haenszel test with stratification according to baseline distribution of CAV incidence.

    Measured: within 5-7 years

  2. Percent of Participants With Incidence of Coronary Allograft Vasculopathy (CAV)

    Cardiac Allograft Vasculopathy (CAV) was defined as mean maximal intimal thickness (MIT)

    ≥0.5 mm, measured for the entire matched pullback recording by intravascular ultrasound (IVUS). The incidence of CAV at 5-7 years was compared between groups using the Cochran-Mantel-Haenszel test with stratification according to baseline distribution of CAV incidence.

    Measured: at the 5-7 year follow-up

  3. Myocardial Structure and Function

    Myocardial structure and function by echocardiography assessment measured by ventricular end systolic diameter.

    Measured: within 5-7 years

  4. Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up

    This Quality of life Short Form Survey with 36 items (Minnesota Living with Heart Failure Questionnaire)was administered to patients pre-transplantation and after transplantation at the 5-7 year visit. This data represents the change. The survey consist of scores on a scale. Each form is scaled from 0 t 100. 0 = maximum disability and 100 equals no disability.

    Measured: at the 5-7 year visit

  5. Change From Baseline in the Euro Quality of Life 5D

    Change from baseline in Euro Quality of Life-5D from 3 Year Follow-Up to 5 to 7 Year Follow-Up Baseline Visit 1 (ITT Set)

    Euro Quality of Life 5D (EQ-5D): is a descriptive system of healthrelated quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) each of which can be assessed as one of three levels of severity (no problems/some or moderate problems/extreme problems). A Visual Analogue Scale (VAS)-scale is also included in the EQ-5D questionnaire.

    The EQ-5D index is calculated based on the United Kingdom Time Trade-Off (TTO) N3 value set which converts the five dimensions scores into a single measure with a possible range from -0.163 (worst possible health state) to +1 (perfect health). A positive change from baseline indicates an improvement in Quality of Life.

    Measured: Baseline, 5-7 year visit

  6. Change From Baseline in Visual Analog Scale (VAS)

    Change in visual analog scale (VAS) from baseline to the 5 to 7 Year follow up visit.

    0 is no pain; and 10 is the worst possible pain

    Measured: baseline, at the 5-7 year visit

  7. Number of Participants With Beck Depression Inventory (BDI)

    Beck Depression Inventory (BDI) Score has the following categories of depression. Normal, Mild, Moderate Severe and Missing.

    Measured: at the 5-7 year visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2016 (estimated)
  2. Study start18 Jan 2016
  3. Primary completion25 Sep 2017
  4. Study completion25 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02864706
Sponsor's protocol ID
CRAD001ANO05
Other IDs
CRAD001ANO026YFU, 2016-000404-28, 2016
Acronym
CRAD001ANO05
Status last verified
Oct 2019
First submitted
1 Jun 2016
Last updated
3 Oct 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • 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.

    PubMed 26820618

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Everolimus, Cyclosporine and Mycophenolate mofetil in people with Heart Transplantation, run by Novartis Pharmaceuticals at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Sweden, Denmark, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measured Glomerular Filtration Rate (mGFR) (time frame: at the 5-7 year follow-up visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02864706, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.

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