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Once-a-day Immunosuppression(CISECON_a_day) (CISECON)

Primary Purpose

Chronic Renal Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
advagrf
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Disease focused on measuring once

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or women at the age of 20 to 65 who had kidney transplantations at least 3 months ago.
  • Recipients of kidney transplantations from a deceased / cadaveric donor, non-heart beating cadaveric donor / organ donor after cardiac death, or non-blood related or blood related live donor.
  • Patients being treated with Tacrolimus or Extended Release Tacrolimus as the existing immunosuppressant maintenance therapy.
  • Able and willing to give informed consent to study participation, having signed the informed consent form according to appropriate procedures, and capable of participating in the study by making visits according to study plans.

Exclusion Criteria:

  • HIV, HBsAg, or anti-HCV test positive patients or having received kidney transplantations from an HIV, HBsAg, or anti-HCV test positive donor.
  • History of severe allergies or hypersensitivities to drugs used in the study or other drugs with a similar chemical structure requiring acute (within the past 4 weeks) or chronic treatment.
  • Having received other investigational product within 30 days prior to enrollment into this study.
  • Women of childbearing potential who plan to become pregnant, pregnant and/or lactating women, women who do not intend to use effective contraceptives.
  • Having uncontrolled diseases or medical conditions requiring continuous treatment.
  • History of alcohol or drug addiction within the past 3 months or incapable of appropriate communications due to reasons such as mental illness.
  • Absolute neutrophil count <1,500/mm3 or leukocyte count <2,500/mm3 or platelet count <75,000/mm3 at screening or severe metabolic disorders (including functional disorders).

  • Having experienced the following condition within the past 1 month:

    • Serum creatinine > 2.0 mg/dl more than twice.
    • 24 hr urine protein≥750 mg/day
    • Diagnosed with or treated for a rejection reaction or an infection or hospitalized due to other medical reasons.

Sites / Locations

  • Nephrology, Pusan National University Hospital
  • Bundang CHA Medical Center,
  • Inje University Ilsan Paik Hospital
  • Korea University Medical Center
  • Severance Hospital
  • Soonchunhyang University Hosptial
  • Dept. of Surgery, Ulsan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

advagraf

Arm Description

The same capacity advagaf + sirolimus

Outcomes

Primary Outcome Measures

acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up
The primary objective of this study is to investigate the efficacy of Advagraf ® (Extended Release Tacrolimus) at 6 months after immunosuppressant conversion to the once daily therapy. The efficacy is defined as the incidence rate of composite endpoints of efficacy failure (acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up).

Secondary Outcome Measures

renal functions
Difference in renal functions (eGFR by MDRD method), urine protein excretion and P/C ratio (A/C ratio), transplant kidney biopsy histology (if biopsy is performed).
serious adverse events
Frequency and severity of adverse events and serious adverse events
cardiovascular health
Treatment impact on cardiovascular health: blood pressure and cardiovascular events (acute myocardial infarction, unstable angina pectoris, heart failure, stroke).
NODAT
Incidence rate of new onset diabetes after transplantation (NODAT) requiring treatment.
hematology issue
Frequency of anemia, leucopenia, and thrombocytopenia.

Full Information

First Posted
October 1, 2013
Last Updated
July 19, 2016
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01964014
Brief Title
Once-a-day Immunosuppression(CISECON_a_day)
Acronym
CISECON
Official Title
Clinical Investigation for Safety and Efficacy, Patient Reported Outcomes of the Conversion to ONce-a-day Immunosuppression After Kidney Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to assess the efficacy and safety and Immunosuppressant Therapy Barrier Scale (ITBS) of once daily immunosuppressant maintenance therapy in patients who had kidney transplantations earlier.
Detailed Description
This is a 6-month, single-arm, multi-center, open-label, continuous cohort study. 160 subjects who had kidney transplantations at least 3 months earlier will participate in the study. All enrolled subjects will discontinue the existing Tacrolimus preparations for 6 months from enrollment and be converted to Extended Release Tacrolimus at a biologically equivalent dose. They will also discontinue enteric-coated mycophenolate sdium or mycophenolate sodium and be treated with Sirolimus and observed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Disease
Keywords
once

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
advagraf
Arm Type
Experimental
Arm Description
The same capacity advagaf + sirolimus
Intervention Type
Drug
Intervention Name(s)
advagrf
Intervention Description
All enrolled subjects will discontinue the existing Tacrolimus preparations for 6 months from enrollment and be converted to Extended Release Tacrolimus at a biologically equivalent dose. They will also discontinue enteric-coated mycophenolate sdium or mycophenolate sodium and be treated with Sirolimus and observed. advagrf+sirolimus one time to eat.
Primary Outcome Measure Information:
Title
acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up
Description
The primary objective of this study is to investigate the efficacy of Advagraf ® (Extended Release Tacrolimus) at 6 months after immunosuppressant conversion to the once daily therapy. The efficacy is defined as the incidence rate of composite endpoints of efficacy failure (acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up).
Time Frame
6months
Secondary Outcome Measure Information:
Title
renal functions
Description
Difference in renal functions (eGFR by MDRD method), urine protein excretion and P/C ratio (A/C ratio), transplant kidney biopsy histology (if biopsy is performed).
Time Frame
6months
Title
serious adverse events
Description
Frequency and severity of adverse events and serious adverse events
Time Frame
6months
Title
cardiovascular health
Description
Treatment impact on cardiovascular health: blood pressure and cardiovascular events (acute myocardial infarction, unstable angina pectoris, heart failure, stroke).
Time Frame
6months
Title
NODAT
Description
Incidence rate of new onset diabetes after transplantation (NODAT) requiring treatment.
Time Frame
6months
Title
hematology issue
Description
Frequency of anemia, leucopenia, and thrombocytopenia.
Time Frame
6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women at the age of 20 to 65 who had kidney transplantations at least 3 months ago. Recipients of kidney transplantations from a deceased / cadaveric donor, non-heart beating cadaveric donor / organ donor after cardiac death, or non-blood related or blood related live donor. Patients being treated with Tacrolimus or Extended Release Tacrolimus as the existing immunosuppressant maintenance therapy. Able and willing to give informed consent to study participation, having signed the informed consent form according to appropriate procedures, and capable of participating in the study by making visits according to study plans. Exclusion Criteria: HIV, HBsAg, or anti-HCV test positive patients or having received kidney transplantations from an HIV, HBsAg, or anti-HCV test positive donor. History of severe allergies or hypersensitivities to drugs used in the study or other drugs with a similar chemical structure requiring acute (within the past 4 weeks) or chronic treatment. Having received other investigational product within 30 days prior to enrollment into this study. Women of childbearing potential who plan to become pregnant, pregnant and/or lactating women, women who do not intend to use effective contraceptives. Having uncontrolled diseases or medical conditions requiring continuous treatment. History of alcohol or drug addiction within the past 3 months or incapable of appropriate communications due to reasons such as mental illness. Absolute neutrophil count <1,500/mm3 or leukocyte count <2,500/mm3 or platelet count <75,000/mm3 at screening or severe metabolic disorders (including functional disorders). Having experienced the following condition within the past 1 month: Serum creatinine > 2.0 mg/dl more than twice. 24 hr urine protein≥750 mg/day Diagnosed with or treated for a rejection reaction or an infection or hospitalized due to other medical reasons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chang-kwon oh, M.D.,Ph.D.
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nephrology, Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Bundang CHA Medical Center,
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Gyeonggido
Country
Korea, Republic of
Facility Name
Korea University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Soonchunhyang University Hosptial
City
Seoul
Country
Korea, Republic of
Facility Name
Dept. of Surgery, Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

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Once-a-day Immunosuppression(CISECON_a_day)

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