Completed

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

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What is being tested

Everolimus + Low dose CsA +PD

+ Myfortic+ Standard CsA + PD

Drug
Who is being recruted

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: June 2009
See protocol details

Summary

Principal SponsorYonsei University
Last updated: February 19, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2009

Actual date on which the first participant was enrolled.

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.

Principal SponsorYonsei University
Last updated: February 19, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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

Seoul, South KoreaOpen Department of Surgery, Yonsei University College of Medicine, Severance Hospital in Google Maps
CompletedOne Study Center