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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 )

Brief Summary:
A prospective, open label study of CERtican in KIdney transplantation

Condition or disease Intervention/treatment Phase
Kidney Transplant Drug: Everolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Prospective, Open-label Study to Assess Safety of Certican in Kidney Transplant Patients
Study Start Date : March 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arm Intervention/treatment
Kidney transplantation patient
Kidney transplantation patient; single arm
Drug: Everolimus
A prospective, open-label study to assess safety of Certican in kidney transplant patients

Primary Outcome Measures :
  1. Number of participants with serious adverse events [ Time Frame: 12 weeks ]
    frequency of serious adverse event

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01594268

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Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 120-752
Novartis Investigative Site
Seoul, Korea, Republic of, 135-720
Novartis Investigative Site
Seoul, Korea, Republic of, 738-736
Novartis Investigative Site
Suwon, Korea, Republic of, 442-721
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01594268    
Other Study ID Numbers: CRAD001AKR10
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
kidney transplant
Additional relevant MeSH terms:
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Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs