Safety and Efficacy of the Early Introduction of Everolimus (Certican®) With Low Dose of Cyclosporine in de Novo Kidney Recipients After 1 Month of Transplantation

Phase 4

Completed

• Conditions: Planned Kidney Transplantation
• Interventions: Drug: Everolimus + Low dose CsA +PD; Drug: Myfortic+ Standard CsA + PD

• Registration Number: NCT01706471
• Lead Sponsor: Yonsei University

Brief Summary

Calcineurin inhibitors, such as cyclosporine and tacrolimus, have improved allograft survival in kidney organ transplantation. Indeed, they have reduced the incidence of acute rejection episodes of cadaveric allograft recipients. Although marked progression has been made in initial survival rates, long-term kidney graft survival has yet to show such encouraging results. Because CNIs are associated with adverse effects, particularly nephrotoxicity, which contribute to declining organ function and eventual graft loss. In kidney transplants, progressive allograft dysfunction has been shown to develop in as many as 94% of patients by 1 year.

Therefore, reducing or eliminating the dose of CNIs to minimize nephrotoxicity must be balanced against the maintenance of adequate immunosuppression.

Certican allows CNI dose reduction then provides renal function improvement and current PSI strategy point out that early intervention is important in managing the risk of CAN before it develops in both de novo and maintenance renal transplant recipients.

To demonstrate Certican early introduction after 1 month provides better renal function with no change of efficacy compared to standard regimen, and also prevent delayed wound healing.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-15
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-17
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Males or Females aged 18~65 years
2. De novo recipients of cadaveric, living unrelated or living related donor kidney transplants
3. Received kidney transplant from aged 10~65years donor
4. Willing to provide written informed consent
5. Completing study visits according to study protocol

Exclusion Criteria

1. Recipients of multiple organ transplants

2. Kidney transplant from non-heart beating cadaveric donor / organ donor after cardiac death

3. Recipients of A-B-O incompatible transplants or lymphocyte cross-match positive transplants

4. Recipients of extra-renal solid organ transplants or stem cell transplants

5. Recipient/ donor who are known to have anti-HCV, HIV or HBsAg positive

6. Diagnosed as Cancer within the past 5 years (except complete recovered squamous cell or basal cell skin cancer)

7. Drug Hypersensitivity to investigational drugs or related drugs Females are pregnant and lactating

8. Any of the following laboratory abnormalities at screening:

   • ALT, AST, ALP, total bilirubin > 3 times the upper limit
   • ANC < 1,500mm3 or WBC < 2,500mm3 or platelet < 100,000 mm3
   • Cholesterol > 350 mg/dl or 9.0 mmol/L, TG > 500 mg/dl or 5.6mmol/L

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Everolimus + Low dose CsA +PD	Everolimus + Low dose CsA +PD	-
Myfortic+ Standard CsA + PD	Myfortic+ Standard CsA + PD	-

Primary Outcome Measures

Name	Time	Method
Reduced Exposure Cyclosporine in Renal Transplant Recipients	12 months after the time of kidney transplantation	A 12-month, multi center, randomized, open-label, non-inferiority study of efficacy and safety comparing early introduction of Certican® after 1 month and standard regimen in de novo renal transplant recipients

Trial Locations

Locations (1)

Department of Surgery, Yonsei University College of Medicine, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of