Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 21 November 2022
• Main ID: NCT02555787
• Date of registration: 18/09/2015
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Europe Ltd.
• Public title: Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients CHORUS
• Scientific title: Global Multicentre Kidney Transplant Advagraf Conversion Registry. A Non-interventional Post-authorisation Study (PAS)
• Date of first enrolment: March 5, 2015
• Target sample size: 4430
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02555787
• Study type: Observational

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Czechia, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Philippines, Poland, Portugal, Romania, Serbia, Spain, Taiwan, Thailand, United Kingdom, United States, Vietnam

Contacts

• Name: Medical Affairs Europe
• Affiliation: Astellas Pharma Europe Ltd.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult kidney transplant patients who are on tacrolimus BD and identified for
conversion to Advagraf. Patients will only be approached about participating in the
registry after their physician has made the decision to convert them to Advagraf.
Patients previously treated with Advagraf and who have stopped for any reason will not
be excluded from the registry provided that the physician has decided to convert.

Exclusion Criteria:

- Patients currently taking Advagraf treatment



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Kidney Transplantation

Intervention(s)

Drug: Tacrolimus

Primary Outcome(s)

Change in renal function as measured by eGFR using the MDRD-4 formula [Time Frame: At transplantation, within 3 months after transplantation, up to 2 years pre-conversion and then every 6 months prior to conversion, at conversion (baseline), 12 months post-conversion and annually thereafter until EOS (up to 5 years post conversion)]

Secondary Outcome(s)

Time to first incidence of BPAR episodes [Time Frame: From transplantation to EOS (up to 5 years post conversion)]

Advagraf dose [Time Frame: From transplantation to EOS (up to 5 years post conversion)]

Current immunosuppressant regimen [Time Frame: From transplantation to EOS (up to 5 years post conversion)]

DSA status (de novo) [Time Frame: From transplantation to EOS (up to 5 years post conversion)]

Status of treatment with Advagraf [Time Frame: From transplantation to EOS (up to 5 years post conversion)]

Tacrolimus trough level [Time Frame: From transplantation to EOS (up to 5 years post conversion)]

Change in renal function as measured by eGFR using the CKD-Epi formula [Time Frame: At transplantation, within 3 months after transplantation, up to 2 years pre-conversion and then every 6 months prior to conversion, at conversion (baseline), 12 months post-conversion and annually thereafter until EOS (up to 5 years post conversion)]

Overall graft survival (time to graft loss) [Time Frame: From transplantation to date of graft loss]

Overall patient survival [Time Frame: From transplantation to EOS (up to 5 years post conversion) or date of death from any cause]

Incidence of BPAR episodes [Time Frame: From transplantation to EOS (up to 5 years post conversion)]

Secondary ID(s)

506-MA-1002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors