A Prospective, Open Label Study of CERtican in KIdney Transplantation (CERKI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01594268
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : March 21, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

May 4, 2012
May 9, 2012
March 21, 2017
March 2012
October 2013   (Final data collection date for primary outcome measure)
Number of participants with serious adverse events [ Time Frame: 12 weeks ]
frequency of serious adverse event
Same as current
Complete list of historical versions of study NCT01594268 on Archive Site
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A Prospective, Open Label Study of CERtican in KIdney Transplantation
A Prospective, Open-label Study to Assess Safety of Certican in Kidney Transplant Patients
A prospective, open label study of CERtican in KIdney transplantation
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Kidney Transplant
Drug: Everolimus
A prospective, open-label study to assess safety of Certican in kidney transplant patients
Kidney transplantation patient
Kidney transplantation patient; single arm
Intervention: Drug: Everolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2013
October 2013   (Final data collection date for primary outcome measure)

Inclusion criteria: (Each patient must meet all of the following criteria.)

  1. Males and females aged 20-65 years inclusive (in Korean age) who is scheduled to receive a primary kidney transplant.
  2. Patients who received explanation of the study overview and signed on the informed consent form of this study.
  3. de novo patients who are going to receive a kidney transplant from a deceased (cold ischemic time (CIT) < 36 hours), living unrelated or related donor

Exclusion criteria (Any patient who meets any of the following criteria will not be able to participate in the study.)

  1. Multi-organ transplant recipients (e.g. simultaneous kidney-pancreas transplant) or patients who previously received an organ transplant other than a kidney transplant
  2. Patients who are scheduled to receive a kidney transplant from a zero-antigen mismatched donor, bilateral kidney donor, a non-heart beating donor or a donor aged over 60 years
  3. Patients who should avoid potential exposure to everolimus due to acute or chronic severe allergy treatment or patients who have hypersensitivity to everolimus and drugs of similar chemical classes (e.g. macrolides)
  4. Class 1 PRA>30% by CDC-based assay or Class 1 PRA>50% by flow cytometry or EIA
  5. Recipients of a kidney from a ABO-incompatible live-donor or T-cell cross matching-positive donor
  6. Thrombocytopenia<75,000/mm3, absolute neutrophil count<1,500/mm3, and/or leukopenia<4,000/mm3
  7. Severe hypercholesterolemia (350mg/dl) or hypertriglyceridemia (>500mg/dl) (However, patients with controlled hyperlipidemia are eligible for the study.)
  8. Use of other investigational drugs for 30 days before enrollment in the study
  9. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years before enrollment in the study, regardless of whether there is evidence of local recurrence or metastases
  10. Pregnant or nursing women, and women of child-bearing potential who have a plan to be pregnant or do not consent to select an appropriate method of birth control (e.g. oral contraceptives, hormone implant, IUD, diaphragm barrier, condom, abstinence, etc.) (women of child-bearing potential means women less than 2 years post-menopausal or not having hysterectomy or surgical management, i.e. bilateral tubal ligation or bilateral oophorectomy)
  11. Presence of surgery or medical condition (except for current transplant) which may change absorption, distribution, metabolism, and excretion of the investigational product at the investigator's discretion and/or severe diarrhea, active gastrointestinal disease or uncontrolled diabetes
  12. Patients who are HIV-, HCV-, and HBV positive
  13. Recipients of an organ from a donor who is HBsAg-, HCV-, and HIV-positive
  14. Evidence of drug or alcohol abuse
  15. Severe restrictive or obstructive pulmonary disease
  16. Patients with severe liver disease (AST, ALT or total bilirubin>2.5 times ULN including abnormal liver function test)
  17. Patients with severe systemic infection requiring continuous therapy which may influence the objectives of the study at the investigator's discretion
  18. Patients in whom continuous treatment may lead to clinically serious infection at the investigator's discretion or patients with other severe surgery complications or problems with continuous wound treatment
  19. Patients who have a genetic problem including galactose intolerance, lapp lactase deficiency, and glucose-galactose malabsorption
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP