Once-a-day Immunosuppression(CISECON_a_day)

Chronic Renal Disease Clinical Trial

— CISECON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964014
• Other study ID #: MED-CT4-11-391
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2013
• Last updated: July 19, 2016
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: July 2016
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Disease
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	serious adverse events	Frequency and severity of adverse events and serious adverse events	6months	No
Secondary	cardiovascular health	Treatment impact on cardiovascular health: blood pressure and cardiovascular events (acute myocardial infarction, unstable angina pectoris, heart failure, stroke).	6months	No
Secondary	NODAT	Incidence rate of new onset diabetes after transplantation (NODAT) requiring treatment.	6months	No
Secondary	hematology issue	Frequency of anemia, leucopenia, and thrombocytopenia.	6months	No