NCT01594268

Brief Summary

A prospective, open label study of CERtican in KIdney transplantation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

1.6 years

First QC Date

May 4, 2012

Last Update Submit

March 17, 2017

Conditions

Kidney Transplant

Keywords

kidney transplantCertican

Outcome Measures

Primary Outcomes (1)

  • Number of participants with serious adverse events

    frequency of serious adverse event

    12 weeks

Study Arms (1)

Kidney transplantation patient

OTHER

Kidney transplantation patient; single arm

Drug: Everolimus

Interventions

EverolimusDRUG

A prospective, open-label study to assess safety of Certican in kidney transplant patients

Kidney transplantation patient

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females aged 20-65 years inclusive (in Korean age) who is scheduled to receive a primary kidney transplant.
  • Patients who received explanation of the study overview and signed on the informed consent form of this study.
  • 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

You may not qualify if:

  • Multi-organ transplant recipients (e.g. simultaneous kidney-pancreas transplant) or patients who previously received an organ transplant other than a kidney transplant
  • 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
  • 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)
  • Class 1 PRA\>30% by CDC-based assay or Class 1 PRA\>50% by flow cytometry or EIA
  • Recipients of a kidney from a ABO-incompatible live-donor or T-cell cross matching-positive donor
  • Thrombocytopenia\<75,000/mm3, absolute neutrophil count\<1,500/mm3, and/or leukopenia\<4,000/mm3
  • Severe hypercholesterolemia (350mg/dl) or hypertriglyceridemia (\>500mg/dl) (However, patients with controlled hyperlipidemia are eligible for the study.)
  • Use of other investigational drugs for 30 days before enrollment in the study
  • 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
  • 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)
  • 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
  • Patients who are HIV-, HCV-, and HBV positive
  • Recipients of an organ from a donor who is HBsAg-, HCV-, and HIV-positive
  • Evidence of drug or alcohol abuse
  • Severe restrictive or obstructive pulmonary disease
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigative Site

Seoul, Korea, 120-752, South Korea

Location

Novartis Investigative Site

Seoul, 135-720, South Korea

Location

Novartis Investigative Site

Seoul, 738-736, South Korea

Location

Novartis Investigative Site

Suwon, 442-721, South Korea

Location

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 9, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

March 21, 2017

Record last verified: 2017-03

Locations

KR(4)