Once-a-day Immunosuppression(CISECON_a_day)

NCT01964014 | Completed Phase 4 DMC

• 1 other identifier: MED-CT4-11-391
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 7

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.

Conditions

Chronic Renal Disease

Keywords

once

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• renal functions

  6months

• serious adverse events

  6months

• cardiovascular health

  6months

• NODAT

  6months

• hematology issue

  6months

Study Arms (1)

advagraf

EXPERIMENTAL

The same capacity advagaf + sirolimus

Drug: advagrf

Interventions

advagrf DRUG

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.

advagraf

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• hr urine protein≥750 mg/day
• Diagnosed with or treated for a rejection reaction or an infection or hospitalized due to other medical reasons.

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (7)

Nephrology, Pusan National University Hospital

Busan, South Korea

Location

Bundang CHA Medical Center,

Gyeonggi-do, South Korea

Location

Inje University Ilsan Paik Hospital

Gyeonggido, South Korea

Location

Korea University Medical Center

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Soonchunhyang University Hosptial

Seoul, South Korea

Location

Dept. of Surgery, Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• chang-kwon oh, M.D.,Ph.D.

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor,Department of surgery, Ajou University School of Medicine

Study Record Dates

• First Submitted: October 1, 2013
• First Posted: October 17, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: July 21, 2016

Record last verified: 2016-07

Locations

KR (7)