SCHEDULE Follow Up Visit 5-7 yr

NCT02864706 | Completed Phase 4 Results

• 3 other identifiers: CRAD001ANO05CRAD001ANO026YFU2016-000404-28
• Study Type: interventional
• Target: 95
• Locations: 3 countries
• Sites: 6

Brief 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.

Conditions

Heart Transplantation

Keywords

allograft rejection; xenograft rejection; host vs graft disease; transplant

Outcome Measures

Primary Outcomes (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.

  at the 5-7 year follow-up visit

Secondary Outcomes (7)

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

  within 5-7 years

• Percent of Participants With Incidence of Coronary Allograft Vasculopathy (CAV)

  at the 5-7 year follow-up

• Myocardial Structure and Function

  within 5-7 years

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

  at the 5-7 year visit

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

  Baseline, 5-7 year visit

Study Arms (2)

EVEROLIMUS

EXPERIMENTAL

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

Drug: Everolimus

Control

ACTIVE COMPARATOR

patients received standard CsA, MMF and corticosteroids

Drug: Cyclosporine; Drug: Mycophenolate mofetil; Drug: Corticosteroids

Interventions

Everolimus 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.

EVEROLIMUS

Cyclosporine 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)

Control

Mycophenolate mofetil 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

Control

Corticosteroids 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.

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with a retransplanted heart since the original SCHEDULE study

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Århus N, DK-8200, Denmark

Location

Novartis Investigative Site

Copenhagen, DK-2100, Denmark

Location

Novartis Investigative Site

Oslo, 0372, Norway

Location

Novartis Investigative Site

Gothenburg, 413 45, Sweden

Location

Novartis Investigative Site

Linköping, 581 85, Sweden

Location

Novartis Investigative Site

Lund, 221 85, Sweden

Location

Related Publications (1)

• 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.

  PMID: 26820618 BACKGROUND

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Everolimus; Cyclosporine; Mycophenolic Acid; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

There is no investigational medicinal product (IMP). This study is a single follow-up visit. Hence patients' first and last visit dates are the same.

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

(862) 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: August 12, 2016
• Study Start: January 18, 2016
• Primary Completion: September 25, 2017
• Study Completion: September 25, 2017
• Last Updated: October 3, 2019
• Results First Posted: October 3, 2019

Record last verified: 2019-10

Locations

NO (1); DK (2); SE (3)