Study evaluating the effect of treatment with everolimus in combination with reduced calcineurin inhibitor compared to a standard treatment in kidney transplant recipients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2037

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

This study CRAD001A2433 is designed to evaluate the impact of concentration-controlled everolimus with reduced exposure CNI, comparedto mycophenolic acid (MPA) with standard exposure CNI, with respect to efficacy and safety in de novo renal transplant recipients.

Phase 1

ovartis Pharma Services AG

Updated 9/3/2018

Efficacy and safety of concentration-controlled everolimus with reduced Calcineurin Inhibitor (CNI) exposure, compared to Mycophenylate (MPA) and stand CNI exposure in de novo kidney transplant.

Phase 1

ovartis Pharma Services AG

Updated 2/19/2018

This study CRAD001A2433 is designed to evaluate the impact of concentration-controlled everolimus with reduced exposure CNI, compared to mycophenolic acid (MPA) with standard exposure CNI, with respect to efficacy and safety in de novo renal transplant recipients.

Phase 1

ovartis Pharma Services AG

Updated 8/27/2018

A

Phase 1

ovartis Farma SpA

Updated 2/19/2018