Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000664741
Ethics application status
Approved
Date submitted
15/01/2022
Date registered
5/05/2022
Date last updated
6/04/2023
Date data sharing statement initially provided
5/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Conversion lung transplant patients from Prograf to Advagraf or Envarsus
Scientific title
Pharmacokinetic Study of Conversion Between 2 Formulations of Tacrolimus in Stable Lung Transplant Patients
Secondary ID [1] 306216 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
for patient with lung transplantation 324929 0
Condition category
Condition code
Respiratory 322362 322362 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
tacrolimus: dose administered 1 mg once daily
the total duration of administration 3 years
the mode of administration tablet
prolonged release formulation (Advagraf, Envarsus)
Intervention code [1] 323249 0
Treatment: Drugs
Comparator / control treatment
comparator - tacrolimus once daily for 1 month
twice daily tacrolimus (Prograf) 1 mg twice daily
Control group
Active

Outcomes
Primary outcome [1] 330134 0
pharmacokinetics parameters of tacrolimus: AUC Cmax, Tmax. Assesed plasma level
Timepoint [1] 330134 0
blood samples taken at 24 hours post dose
Primary outcome [2] 331240 0
lung function assessed using spirometry. Spirometer
Timepoint [2] 331240 0
1 year post transplant
Secondary outcome [1] 404995 0
compliance questionnaire (The Basel Assessment of adherence to immunosupressive medication scale)
Timepoint [1] 404995 0
3 years post-transplant

Eligibility
Key inclusion criteria
minimum age 18 years, 30 days after lung transplant, need to be prescribed tacrolimus (Advagraf, Envarsus) once daily for 30 days after lung transplant
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
refusal to participate in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
20
Final
Recruitment outside Australia
Country [1] 24504 0
Czech Republic
State/province [1] 24504 0
Prague

Funding & Sponsors
Funding source category [1] 310565 0
Hospital
Name [1] 310565 0
Motol University Hospital
Country [1] 310565 0
Czech Republic
Primary sponsor type
Hospital
Name
University Hospital Motol
Address
V Úvalu 84/1
150 06 Praha 5
Country
Czech Republic
Secondary sponsor category [1] 311741 0
None
Name [1] 311741 0
Address [1] 311741 0
Country [1] 311741 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310173 0
Motol ethics committee
Ethics committee address [1] 310173 0
V Úvalu 84/1
150 06 Praha 5
Ethics committee country [1] 310173 0
Czech Republic
Date submitted for ethics approval [1] 310173 0
Approval date [1] 310173 0
01/12/2020
Ethics approval number [1] 310173 0

Summary
Brief summary
30 days after lung transplantation patients with tacrolimus (Prograf) will be transfered randomisation to once daily tacrolimus (Advagraf, Envarsus)
Which product will be better evaluated Advagraf or Envarsus
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116746 0
Mrs Eliška Dvorácková
Address 116746 0
Department of Pharmacology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Albertov 4, 128 00 Prague 2, Czech Republic
Country 116746 0
Czech Republic
Phone 116746 0
+420 721132330
Fax 116746 0
Email 116746 0
eliskadvorackova@seznam.cz
Contact person for public queries
Name 116747 0
Mrs Eliška Dvorácková
Address 116747 0
Department of Pharmacology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Albertov 4, 128 00 Prague 2, Czech Republic
Country 116747 0
Czech Republic
Phone 116747 0
+420721132330
Fax 116747 0
Email 116747 0
eliskadvorackova@seznam.cz
Contact person for scientific queries
Name 116748 0
Mrs Eliška Dvorácková
Address 116748 0
Department of Pharmacology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Albertov 4, 128 00 Prague 2, Czech Republic
Country 116748 0
Czech Republic
Phone 116748 0
+420721132330
Fax 116748 0
Email 116748 0
eliskadvorackova@seznam.cz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
none


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.