EUCTR2013-000322-66-HRActive, not recruitingPhase 1
A 24 month, multicenter, randomized, open-label safety and efficacy study of concentration-controlled everolimus with reduced calcineurin inhibitor vs mycophenolate with standard calcineurin inhibitor in de novo renal transplantation - Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen (TRANSFORM) - Advancing renal TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen (TRANSFORM)
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 2,037
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •1. Written informed consent obtained.
- •2. Subject randomized within 24 hr of completion of transplant surgery.
- •3. Recipient of a kidney with a cold ischemia time < 30 hours.
- •4. Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased heart beating, living unrelated, living related non-human leukocyte antigen identical or an expanded criteria donor.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2040
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
Exclusion Criteria
- •1. Subject unable to tolerate oral medication at time of randomization.
- •2. Use of other investigational drugs at the time of enrollment
- •3. History of hypersensitivity to any of the study drugs or similar chemical classes.
- •4. multi-organ transplant recipient
- •5. Recipient of ABO incompatible allograft or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant
- •6. high immunological risk by assessment of anti-donor reactivity e.g. high PRA, presence of pre-existing DSA
- •7. HIV positive
- •8. HBsAg and/or a HCV positive with evidence of elevated LFTs (ALT/AST levels = 2.5 times ULN)
- •9. Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV)
- •10. BMI greater than 35
- •11. severe systemic infections
- •12. Subject requiring systemic anticoagulation
- •13. History of malignancy
- •14. severe restrictive or obstructive pulmonary disorders
- •15. severe hypercholesterolemia or hypertriglyceridemia
- •16. white blood cell (WBC) count = 2,000 /mm3 or with platelet count = 50,000 /mm3.
- •17. Pregnant or nursing (lactating) women
- •18. Women of child-bearing potential
Investigators
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