Completed

NCT Number: 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

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.

Completed

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Key information

Conditions

Planned Kidney Transplantation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Surgery, Yonsei University College of Medicine, Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Recipients of multiple organ transplants
Kidney transplant from non-heart beating cadaveric donor / organ donor after cardiac death
Recipients of A-B-O incompatible transplants or lymphocyte cross-match positive transplants
Recipients of extra-renal solid organ transplants or stem cell transplants
Recipient/ donor who are known to have anti-HCV, HIV or HBsAg positive
Diagnosed as Cancer within the past 5 years (except complete recovered squamous cell or basal cell skin cancer)
Drug Hypersensitivity to investigational drugs or related drugs Females are pregnant and lactating
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

Treatment and study plan

Everolimus + Low dose CsA +PD

Drug

Group A : Initiation of 5mg/kg bid Neoral dose and 720mg bid Myfortic and then adjusting Neoral targeting 150-200ng. After 1 month reduce Neoral dose as following table and Certican starting 0.75mg bid then adjust Certican 3-8ng/ml. Myfortic continue until Certican trough level goes up >3 ng/mL. Steroid dose follows local protocol.

Myfortic+ Standard CsA + PD

Drug

Group B : Initiation of 5mg/kg bid Neoral dose and 720mg bid Myfortic and then adjusting Neoral targeting 150-200ng/ml. After 1 month reduce Neoral dose targeting 100-200ng with no change of Myfortic dose. Steroid dose follows local protocol.

Primary outcomes

Reduced Exposure Cyclosporine in Renal Transplant Recipients

Time frame: 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Oct 15, 2012
Registry last updated: Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.