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

Clinical Investigation for Safety and Efficacy, Patient Reported Outcomes of the Conversion to ONce-a-day Immunosuppression After Kidney Transplantation

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.

Study Overview

• Status: Completed
• Conditions: Chronic Renal Disease
• Intervention / Treatment: Drug: advagrf

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Nephrology, Pusan National University Hospital
  • Gyeonggi-do, Korea, Republic of
    • Bundang CHA Medical Center,
  • Gyeonggido, Korea, Republic of
    • Inje University Ilsan Paik Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Medical Center
  • Seoul, Korea, Republic of
    • Soonchunhyang University Hosptial
  • Ulsan, Korea, Republic of
    • Dept. of Surgery, Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: advagraf; The same capacity advagaf + sirolimus	Drug: advagrf; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6months
serious adverse events	Frequency and severity of adverse events and serious adverse events	6months
cardiovascular health	Treatment impact on cardiovascular health: blood pressure and cardiovascular events (acute myocardial infarction, unstable angina pectoris, heart failure, stroke).	6months
NODAT	Incidence rate of new onset diabetes after transplantation (NODAT) requiring treatment.	6months
hematology issue	Frequency of anemia, leucopenia, and thrombocytopenia.	6months

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: chang-kwon oh, M.D.,Ph.D., Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 1, 2013
• First Submitted That Met QC Criteria: October 14, 2013
• First Posted (Estimate): October 17, 2013

Study Record Updates

• Last Update Posted (Estimate): July 21, 2016
• Last Update Submitted That Met QC Criteria: July 19, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: once
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: MED-CT4-11-391