Phase 4
Completed N=115
SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance
Renal Function and Chronic Allograft Vasculopathy
Source: ClinicalTrials.gov NCT01266148 ↗
Enrolled (actual)
115
Serious AEs
47.0%
Results posted
May 2014
Primary outcomePrimary: Measured Glomerular Filtration Rate (mGFR), 12 Months After Heart Transplantation — 79.8; 61.5 mGFR ml/min
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measured Glomerular Filtration Rate (mGFR), 12 Months After Heart Transplantation |
79.8; 61.5 | — |
| SECONDARY Progression of Chronic Allograft Vasculopathy (CAV) Based on Maximal Intimal Thickness (MIT) From Baseline to Week 52 |
0.52; 0.56; 0.55; 0.65 | — |
| SECONDARY Progression of Chronic Allograft Vasculopathy (CAV) Based on Incidence of Chronic Allograft Vasculopathy (CAV) From Baseline to Week 52 |
43.5; 47.9; 56.5; 52.1; 50; 35.4 | — |
| SECONDARY Change in Calculated Glomerular Filtration Rate From Pre-transplantation to Week 52 |
-13.0; -12.6; 7.4; -6.8; 27.8; -8.0 | — |
| SECONDARY Calculated Glomerular Filtration Rate From Pre-Transplantation to Week 52 |
65.4; 66.1; 84.9; 69.6; 104.5; 69.3 | — |
| SECONDARY Number of Rejections Leading to Hemodynamic Compromise |
185; 128; 43; 17; 0; 0 | — |
| SECONDARY Occurrence of Treatment Failures up to 12 Months After Transplant |
2; 3; 0; 0; 2; 3 | — |
| SECONDARY Average Level of Protenuria at Week 52 |
7.2; 1.2 | — |
| SECONDARY Lipid Profile at 12 Months |
5.3; 5.1; 2.9; 2.8; 1.6; 1.6 | — |
| SECONDARY Change in Quality of Life Assessed by SF-36 (Minnesota Living With Heart Failure Questionnaire ([MLHF)]) From Pre-transplant to Week 52 of Treatment |
30.8; 32.9; 48.8; 48.8; 46.2; 38.7 | — |
| SECONDARY Change in Quality of Life - Euro Quality of Life 5D (EQ-5D) |
0.5750; 0.5069; 0.8329; 0.8367; 46.0; 38.9 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01266148). 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.