A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant

Completed

• Conditions: Liver Transplant; Kidney Transplant
• Interventions: Drug: Tacrolimus

• Registration Number: NCT02057484
• Lead Sponsor: Astellas Pharma Europe Ltd.

Brief Summary

The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients. This study will also evaluate the overall long-term impact of Advagraf on kidney and liver allograft recipients.

Detailed Description

Prograf is one of the medications taken by a patient after they have had a liver or kidney transplant to prevent their body from rejecting the new liver or kidney transplant. Prograf is taken by the patient twice a day. Advagraf is a similar medication but is taken by the patient only once a day. There is some evidence emerging that may show that this once-a-day medication may show additional benefits over the twice a day medication, such as, patients more likely to remember to take this medication. Also, this once a day medication is slowly released in the body through the course of a day which in turn may provide better protection against the body rejecting the new transplanted organ over a longer period.

This study will follow up adult patients who were previously enrolled in an Advagraf trial after they have had a liver or kidney transplant. The information collected for this study will be information that the patient's doctor will normally collect when he/she sees the patient for their regular check-ups. Information will be collected once a year for a period of 5 years from when the patient received their new organ transplant. It is hoped that patient information collected during the study will provide prescribers with useful information in treatment of organ transplant patients.

Study Timeline

• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-05
• Study First Posted: 2014-02-07
• Study Start: 2014-03-03
• Primary Completion: 2017-10-17
• Study Completion: 2017-10-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2300

Inclusion Criteria

• Participated in one of the selected Astellas sponsored clinical trials :

  • DIAMOND - PMR-EC-1106
  • ADVANCE - PMR-EC-1211
  • ADHERE - PMR-EC-1212
  • Or, any potential new Astellas-sponsored Advagraf trial

• Assigned to treatment with Advagraf in one of the selected Astellas sponsored clinical trials and received a kidney or liver organ transplant.

NOTE: The primary objective is to study long-term graft survival in patients currently or previously treated with Advagraf. Therefore patients do not have to be currently receiving Advagraf to be included, nor do they have to have completed a previous Astellas clinical trial.

Exclusion Criteria

• No exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Organ transplant patients treated with Advagraf	Tacrolimus	To evaluate long-term graft survival in patients treated with Advagraf

Primary Outcome Measures

Name	Time	Method
Overall graft survival (time to graft loss)	Annually from date of transplant and for 5 five years	At each annual visit there will be a simple assessment to determine if the graft has survived or not.

Secondary Outcome Measures

Name	Time	Method
Medical conditions of interest	Annually from date of transplant and for 5 five years	Medical conditions of interest include, diabetes mellitus, and cardiovascular conditions such as myocardial infarction and strokes.
Emergence of de novo Donor Specific Antibody	Annually from date of transplant and for 5 five years	If the site collects this information as part of routine clinical practice, only then will this information be collected.
Immunosuppression regimen	Annually from date of transplant and for 5 five years	Any immunosuppression regimen, doses and changes in doses from one annual visit to another, as well any annual trough levels of tacrolimus.
Overall patient survival	Annually from date of transplant and for 5 five years	At each annual visit there will be a simple assessment to determine if the patient has survived or not.
Renal Function	Annually from date of transplant and for 5 five years	At each annual visit serum creatinine results, which is part of routine clinical practice will be collected from the patient's medical records. This will be used by the sponsor to calculate estimated glomerular filtration rate.
Biopsy proven acute rejection episodes	Annually from date of transplant and for 5 five years	All rejection episodes captured in the medical records of the patient from one annual visit to the next will be collected for this study
Infections of interest	Annually from date of transplant and for 5 five years	Infections of interest include cytomegalovirus and BK virus

Trial Locations

Locations (145)

Site AT43001; 🇦🇹 Innsbruck, Austria

Site AT43003; 🇦🇹 Linz, Austria

Site AT43002; 🇦🇹 Vienna, Austria

Site BY37501; 🇧🇾 Minsk, Belarus

Site BE32007; 🇧🇪 Brussels, Brussels Hoofdstedelijk Gewest, Belgium

Site BE32002; 🇧🇪 Brussels, Belgium

Site BE32001; 🇧🇪 Gent, Belgium

Site BE32003; 🇧🇪 Leuven, Belgium

Site BE32005; 🇧🇪 Leuven, Belgium

Site BE32008; 🇧🇪 Liege, Belgium

Scroll for more (135 remaining)