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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

A prospective, open label study of CERtican in KIdney transplantation

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

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	54 participants
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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Investigators

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Clinical Trial Results for CRAD001AKR10 at Novartis Clinical Trials 

Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01594268 History of Changes
Other Study ID Numbers:	CRAD001AKR10
First Posted:	May 9, 2012
Last Update Posted:	March 21, 2017
Last Verified:	March 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

kidney transplant; Certican

Additional relevant MeSH terms:

Everolimus; Sirolimus; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors	Physiological Effects of Drugs; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antifungal Agents