Phase 4
N=115
SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance
Renal Function and Chronic Allograft Vasculopathy
Bottom Line
View on ClinicalTrials.gov: NCT01266148 ↗Enrolled (actual)
115
Serious AEs
47.0%
Results posted
May 2014
Primary outcome: Primary: Measured Glomerular Filtration Rate (mGFR), 12 Months After Heart Transplantation — 79.8; 61.5 mGFR ml/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cyclosporine (Drug); Mycophenolate mofetil (Drug); Corticosteroids (Drug); Everolimus (Drug); Anti Thymocyte Globulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2012
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 | — |
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
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.