NCT01964014

Once-a-day Immunosuppression(CISECON_a_day)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Ajou University School of Medicine · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Renal Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-10-17
• Last updated: 2016-07-21

Locations

7 sites across 1 country: South Korea