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
- Conditions
- renal transplant
- Registration Number
- JPRN-jRCT1080222366
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 2040
1. Subject randomized within 24 hr of completion of transplant surgery.
2. Recipient of a kidney with a cold ischemia time < 30 hr.
3. 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.
1. Subject unable to tolerate oral medication at randomization.
2. Use of other investigational drugs at the time of enrollment, or within 30 days or five half-lives of enrollment, whichever is longer.
3. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
4. Subject is a multi-organ transplant recipient.
5. Recipient of ABO incompatible allograft or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant.
6. Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity.
7. Subject who is HIV positive.
8. HBsAg and/or a HCV positive subject with evidence of elevated LFTs (ALT/AST levels more than or equal to 2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable.
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. Subject with a BMI greater than 35.
11. Subject with severe systemic infections, current or within the two weeks prior to randomization.
12. Subject requiring systemic anticoagulation that cannot be temporarily interrupted and which would preclude renal biopsy.
13. History of malignancy .
14. Subject with severe restrictive or obstructive pulmonary disorders.
15. Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled.
16. Subject with white blood cell (WBC) count less than or equal to 2,000 /mm3 or with platelet count less than or equal to 50,000 /mm3.
17. Pregnant or nursing (lactating) women.
18. Women of child-bearing potential, unless they are using effective methods of contraception during dosing of study treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or eGFR < 50 mL/min/1.73m2 <br><br>Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or eGFR < 50 mL/min/1.73m2 at Month 12 post-transplantation.
- Secondary Outcome Measures
Name Time Method