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OpenTrials
Completed

NCT Number: NCT02555787

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

A study to evaluate changes over time in renal function from baseline (time of conversion) up until five years post conversion in kidney transplant patients converted from tacrolimus twice daily (BD) formulations to a once daily formulation as Advagraf.

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site AU6107, Camperdown, New South Wales, Australia

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About this study

This is a multicenter long-term (up to five years post-conversion), non-interventional registry in kidney transplant patients who have been converted from tacrolimus BD to Advagraf. Centers that are providing medical care for kidney transplant patients who may convert patients from tacrolimus BD to Advagraf will be identified and requested to approach patients for consent to participate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

oral

Other names: FK506E, Advagraf, Astagraf XL, Prograf XL

Primary outcomes

  1. 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)

    Estimated Glomerular Filtration Rate (eGFR), Modification Diet in Renal Disease (MDRD-4), End of Study (EOS)

Secondary outcomes

  1. 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)

    Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi)

  2. Overall patient survival

    Time frame: From transplantation to EOS (up to 5 years post conversion) or date of death from any cause

    Patients who are lost to follow up or alive at EOS - or at time of analysis will be censored

  3. Overall graft survival (time to graft loss)

    Time frame: From transplantation to date of graft loss

    Defined as time from transplantation to graft loss. Graft loss is defined as re-transplantation, nephrectomy, death or as dialysis ongoing at end of study or at the time of discontinuation of the patient from the study. The date of graft loss is the earliest date of any of these events. In case of dialysis as reason for graft loss, the date of graft loss is the first day of the last ongoing dialysis period reported

  4. DSA status (de novo)

    Time frame: From transplantation to EOS (up to 5 years post conversion)

    Donor Specific Antibody (DSA). Laboratory assessment performed where possible in accordance with standard of care

  5. Incidence of BPAR episodes

    Time frame: From transplantation to EOS (up to 5 years post conversion)

    Biopsy Proven Acute Rejection (BPAR). Severity by Banff classification (International standardisation of criteria for histological diagnosis of allograft rejection), treated and untreated, and steroid sensitive or resistant

  6. Time to first incidence of BPAR episodes

    Time frame: From transplantation to EOS (up to 5 years post conversion)

    Severity by Banff classification, treated and untreated, and steroid sensitive or resistant

  7. Advagraf dose

    Time frame: From transplantation to EOS (up to 5 years post conversion)

  8. Tacrolimus trough level

    Time frame: From transplantation to EOS (up to 5 years post conversion)

  9. Current immunosuppressant regimen

    Time frame: From transplantation to EOS (up to 5 years post conversion)

    Dose and formulation (additional to or instead of Advagraf)

  10. Status of treatment with Advagraf

    Time frame: From transplantation to EOS (up to 5 years post conversion)

    Patients who discontinued Advagraf treatment will be retained in the registry for data on long-term outcomes provided consent is not withdrawn. The reasons associated with the discontinuation will be recorded

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe Ltd.

Industry

Registry information

Official study title

Global Multicentre Kidney Transplant Advagraf Conversion Registry. A Non-interventional Post-authorisation Study (PAS)

Acronym: CHORUS

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2015
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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