Clinical trial NCT01706471: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Planned Kidney Transplantation
Keywords: verLowCNI
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduced Exposure Cyclosporine in Renal Transplant Recipients
timeFrame: 12 months after the time of kidney transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Yonsei University College of Medicine, Severance Hospital
Study officials:
References:
citation: Oh CK, Huh KH, Ha J, Kim YH, Kim YL, Kim YS. Safety and efficacy of the early introduction of everolimus with reduced-exposure cyclosporine a in de novo kidney recipients. Transplantation. 2015 Jan;99(1):180-6. doi: 10.1097/TP.0000000000000225.