Status:
COMPLETED
SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Function and Chronic Allograft Vasculopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT01266148
Start Date
November 1 2009
End Date
December 1 2012
Last Update
June 10 2015
Active Locations (6)
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1
Novartis Investigative Site
Århus N, Denmark, DK-8200
2
Novartis Investigative Site
Copenhagen, Denmark, DK-2100
3
Novartis Investigative Site
Oslo, Norway, 0424
4
Novartis Investigative Site
Gothenburg, Sweden, 413 45