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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

This study is currently recruiting participants.
Verified October 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01706471
First received: October 8, 2012
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Planned Kidney Transplantation
 Drug: Everolimus + Low dose CsA +PD
Drug: Myfortic+ Standard CsA + PD
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Reduced Exposure Cyclosporine in Renal Transplant Recipients [ Time Frame: 12 months after the time of kidney transplantation ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 148
Study Start Date: June 2009
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus + Low dose CsA +PD Drug: Everolimus + Low dose CsA +PD
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.
Active Comparator: Myfortic+ Standard CsA + PD Drug: Myfortic+ Standard CsA + PD
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706471

Contacts
Contact: Yu Seun Kim, MD +82-2-2228-2115 yukim@yuhs.ac

Locations
Korea, Republic of
Department of Surgery, Yonsei University College of Medicine, Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Yu Seun Kim, MD            
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01706471     History of Changes
Other Study ID Numbers: 4-2009-0109
Study First Received: October 8, 2012
Last Updated: October 11, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
verLowCNI

Additional relevant MeSH terms:
Mycophenolic Acid
Sirolimus
Mycophenolate mofetil
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2013