SCHEDULE Follow Up Visit 5-7 yr

Phase 4 Completed 95 enrolled Novartis Pharmaceuticals

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2016-01-18
Primary completion: 2017-09-25
Completion: 2017-09-25

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Everolimus: 74.7 (Standard Deviation 23.3) mL/min/1.73m2 NCT02864706 ↗

registry LEAST_SQUARES_MEAN Control: 62.4 (Standard Deviation 16.5) mL/min/1.73m2 NCT02864706 ↗

registry analysis (superiority test); Everolimus vs Control; p = 0.0043; ANCOVA NCT02864706 ↗

Publications

Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cyclosporine	Peptide	—	—
Subject	Everolimus	Small molecule	—	Oral
Comparator	Mycophenolate Mofetil	Small molecule	1500 mg	—
Comparator	Mycophenolate Mofetil	Small molecule	2000 mg	—
Comparator	Mycophenolate Mofetil	Small molecule	3000 mg	—

Indications

No indication recorded.