A Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients

NCT02034747 | Completed Phase 4

• 1 other identifier: ADV-KT-13-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 9

Brief Summary

This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with corticosteroid to Advagraf® with corticosteroid. The eligible patients will be randomized into either Arm 1 or Arm 2. The Arm 1 will be reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks in the Advagraf®-based immunosuppressive regimen, and the Arm 2 will receive the same corticosteroid dose for 24 weeks with Advagraf ®.

Conditions

Kidney Transplant

Keywords

Immunosuppressive regimen; Advagraf; kidney transplant; Corticosteroid

Outcome Measures

Primary Outcomes (1)

• Change in the GFR before the treatment (baseline) to that on Week 24

  Baseline and Week 24

Secondary Outcomes (5)

• Change in the GFR before the treatment (baseline) to that on Week 12

  Baseline and Week 12

• Change in the creatinine clearance before the treatment (baseline) to those on Weeks 12 and 24

  Baseline, Week 12 and Week 24

• Incidence of acute rejection

  Up to Week 24

• Safety assessed by the incidence of adverse events, vital signs and Lab-test

  Up to Week 24

• Physical examinations including cyclosporine related cosmetic side effect

  Up to Week 24

Study Arms (2)

Corticosteroid with the 50% reduced dose

EXPERIMENTAL

oral

Drug: Advagraf; Drug: Corticosteroid

Corticosteroid with the maintained dose

ACTIVE COMPARATOR

oral

Drug: Advagraf; Drug: Corticosteroid

Interventions

Advagraf DRUG

oral

Corticosteroid with the 50% reduced dose; Corticosteroid with the maintained dose

Corticosteroid DRUG

oral

Corticosteroid with the 50% reduced dose; Corticosteroid with the maintained dose

Eligibility Criteria

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

You may qualify if:

• Had a kidney transplant at least 12 months before his/her enrollment in this study (including a kidney retransplantation).
• Underwent a CyA-based immunosuppressive regimen since his/her last transplantation. The CyA dose remained unchanged during the last four weeks before the subject's enrollment.
• The immunosuppressive regimen (combination of medications) remained unchanged for a minimum of four weeks before the subject's enrollment.
• GFR≥30 mL/min

You may not qualify if:

• Had received an organ transplant other than a kidney
• Had an acute rejection episode within 12 weeks before his/her enrollment in this study, or had an acute rejection episode within 24 weeks before his/her enrollment in this study that required anti-lymphocyte antibody therapy
• Had been diagnosed with new-onset malignancy after his/her transplantation, except for basocellular or squamous cell carcinoma of the skin that had been treated successfully
• The subject received a kidney transplant from full-HLA identical donor
• Known to have FSGS or MPGN Type II as an underlying disease
• Has elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigated site
• Has liver cirrhosis

Sponsors & Collaborators

• Astellas Pharma Korea, Inc.: lead

Study Sites (9)

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Chungcheongnam-do, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Gyeonggi-do, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Jeollabuk-do, South Korea

Location

Unknown Facility

Jeollanam-do, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Ulsan, South Korea

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Interventions

Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Medical Director

  Astellas Pharma Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 13, 2014
• Study Start: November 21, 2013
• Primary Completion: November 7, 2015
• Study Completion: November 7, 2015
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (9)