Phase 4
Completed N=95
SCHEDULE Follow Up Visit 5-7 yr
Source: ClinicalTrials.gov NCT02864706 ↗Enrolled (actual)
95
Serious AEs
46.3%
Results posted
Oct 2019
Primary outcomePrimary: Measured Glomerular Filtration Rate (mGFR) — 74.7; 62.4 mL/min/1.73m2 — p=0.0043
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measured Glomerular Filtration Rate (mGFR) |
74.7; 62.4 | 0.0043 sig |
| SECONDARY Progression of Cardiac Allograft Vasculopathy (CAV) Recorded by Intravascular Ultrasound (IVUS) |
0.13; 0.23 | 0.037 sig |
| SECONDARY Percent of Participants With Incidence of Coronary Allograft Vasculopathy (CAV) |
53; 74 | — |
| SECONDARY Myocardial Structure and Function |
3.1; 3.1; 4.7; 4.9 | — |
| SECONDARY Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up |
16.8; 13.2; 10.4; 15.3; 36.7; 40.8 | — |
| SECONDARY Change From Baseline in the Euro Quality of Life 5D |
0.2323; 0.2982 | — |
| SECONDARY Change From Baseline in Visual Analog Scale (VAS) |
35.6; 34.0 | — |
| SECONDARY Number of Participants With Beck Depression Inventory (BDI) |
15; 13; 6; 4; 2; 5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02864706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.