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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01594268
First received: May 4, 2012
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

A prospective, open label study of CERtican in KIdney transplantation


Condition Intervention Phase
Kidney Transplant
Drug: Everolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Prospective, Open-label Study to Assess Safety of Certican in Kidney Transplant Patients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of participants with serious adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    frequency of serious adverse event


Enrollment: 54
Study Start Date: March 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Kidney transplantation patient
Kidney transplantation patient; single arm
Drug: Everolimus
A prospective, open-label study to assess safety of Certican in kidney transplant patients

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594268

Locations
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 120-752
Novartis Investigative Site
Seoul, Korea, Republic of, 738-736
Novartis Investigative Site
Seoul, Korea, Republic of, 135-720
Novartis Investigative Site
Suwon, Korea, Republic of, 442-721
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01594268     History of Changes
Other Study ID Numbers: CRAD001AKR10
Study First Received: May 4, 2012
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration
Korea: Food and Drug Administration

Keywords provided by Novartis:
kidney transplant
Certican

Additional relevant MeSH terms:
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014