Once-a-day Immunosuppression(CISECON_a_day)

Phase 4

Completed

• Conditions: Chronic Renal Disease
• Interventions: Drug: advagrf

• Registration Number: NCT01964014
• Lead Sponsor: Ajou University School of Medicine

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-01
• Study First Submitted QC: 2013-10-14
• Study First Posted: 2013-10-17
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
advagraf	advagrf	The same capacity advagaf + sirolimus

Primary Outcome Measures

Name	Time	Method
acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up	6months	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

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

Trial Locations

Locations (7)

Nephrology, Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Bundang CHA Medical Center,; 🇰🇷 Gyeonggi-do, Korea, Republic of

Soonchunhyang University Hosptial; 🇰🇷 Seoul, Korea, Republic of

Korea University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Gyeonggido, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Dept. of Surgery, Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of