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

Novartis

Status and phase

Completed

Phase 4

Conditions

Renal Function and Chronic Allograft Vasculopathy

Treatments

Drug: Everolimus

Drug: Corticosteroids

Drug: Mycophenolate mofetil

Drug: Anti Thymocyte Globulin

Drug: Cyclosporine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01266148

2009-013074-41 (EudraCT Number)

CRAD001ANO02

Details and patient eligibility

About

A controlled, randomized, open-label, multicenter study evaluating if early initiation of everolimus and early elimination of cyclosporine in de novo heart transplant recipients can improve long-term renal function and slow down the progression of chronic allograft vasculopathy

Full description

This was a prospective, multi-center, randomized, controlled, parallel group, open label study in de novo heart transplant recipients. Patients eligibility for randomization was assessed 5 days after heart transplant.. Patients fulfilling the inclusion and exclusion criteria were randomized to one of two treatment groups: either conventional treatment with Cyclosporine A (CsA), Mycophenolate mofetil (MMF), and corticosteroids (Group A), or low-dose CsA and everolimus, reduced dose MMF, and corticosteroids (Group B). After 7 to 11 weeks, CsA was discontinued in Group B, while the standard triple-drug immunosuppressive regimen was maintained in Group A.

Enrollment

115 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

De novo heart transplant recipients who had received induction therapy with antithomocyte globulin (ATG) were eligible for inclusion.

Recipients of multi-organ transplants or a previous transplant were excluded, as were those with a donor aged > 70 years, cold ischemia time >6 hours, patients with severe systemic infection, recipients of ABO incompatible transplants, patients with severe hypercholesterolemia (>350mg/dL) or hypertriglyceridemia (>750 mg/dL), patients with past (<5 years). In order to continue in the study after week 7-11 (period 1), patients had to complete first 7-11 weeks on randomized immunosuppression and none of the following criteria should be present: Ongoing rejection treatment or experience of one grade 3R rejection or two or more grade 2R rejections during first 7-11 weeks.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

115 participants in 2 patient groups

Everolimus

Experimental group

Description:

Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.

Treatment:

Drug: Mycophenolate mofetil

Drug: Anti Thymocyte Globulin

Drug: Cyclosporine

Drug: Everolimus

Drug: Corticosteroids

Control

Experimental group

Description:

Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.

Treatment:

Drug: Mycophenolate mofetil