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 transplantatio

Phase 1

• Conditions: Adult kidney transplant recipients.; MedDRA version: 16.0Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-000322-66-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-08
• Last Update Posted: 5 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2040

Inclusion Criteria

1. Written informed consent obtained.

2. Male or female subject > and equal 18 years old

3. Subject randomized within 24 hr of completion of transplant surgery.

4. Recipient of a kidney with a cold ischemia time < 30 hours.

5. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified