Clinical trial NCT01964014: Once-a-day Immunosuppression(CISECON_a_day)
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Renal Disease
Keywords: once
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up
timeFrame: 6months
Secondary outcomes:
measure: renal functions
timeFrame: 6months
measure: serious adverse events
timeFrame: 6months
measure: cardiovascular health
timeFrame: 6months
measure: NODAT
timeFrame: 6months
measure: hematology issue
timeFrame: 6months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Nephrology, Pusan National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Bundang CHA Medical Center,
city: Gyeonggido
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hosptial
city: Ulsan
country: Korea, Republic of
facility: Dept. of Surgery, Ulsan University Hospital
Study officials:
affiliation: Ajou University School of Medicine
name: chang-kwon oh, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: