Clinical trial • Phase III • Respiratory

Tacrolimus for Lung transplantation

Phase III trial of Tacrolimus for Lung transplantation.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Lung transplantation
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
27-01-2025
First CTIS Authorization Date
28-01-2025

Trial design

Randomised, prograf 1 mg capsule (tacrolimus) — comparator; oral formulation. product strength listed as 1 mg capsule; max daily dose listed as 10 mg. detailed schedule/dosing regimen not specified in the record.-controlled Phase III trial across 1 site in Netherlands.

Randomised
Yes
Comparator
PROGRAF 1 mg capsule (tacrolimus) — comparator; oral formulation. Product strength listed as 1 mg capsule; max daily dose listed as 10 mg. Detailed schedule/dosing regimen not specified in the record.
Target Sample Size
140
Trial Duration For Participant
730

Eligibility

Recruits 140 No vulnerable populations selected. Participants must be adults (>18 years) and provide written informed consent. No assent procedures or additional consent handling for vulnerable groups are mentioned..

Vulnerable Population
No vulnerable populations selected. Participants must be adults (>18 years) and provide written informed consent. No assent procedures or additional consent handling for vulnerable groups are mentioned.

Inclusion criteria

  • {"criterion_text":"- For both the de novo and conversion study:"}
  • {"criterion_text":"- Single or bilateral lung transplantation"}
  • {"criterion_text":"- Age > 18 years"}
  • {"criterion_text":"- On twice daily tacrolimus with stable trough levels in target range"}
  • {"criterion_text":"- Written informed consent"}
  • {"criterion_text":"- Participant in the TransplantLines biobank study in the UMCG"}
  • {"criterion_text":"- De novo study: De novo lung transplant patients are recruited before transplantation, and subsequently in all patients put on tacrolimus intravenously. Participants can be randomized when they are on stable daily dosage."}
  • {"criterion_text":"- Conversion study: At least one year after lung transplantation with a stable clinical course and lung function"}
  • {"criterion_text":"- eGFR >30ml/min*1.73m2 calculated with the CKD-EPI formula"}

Exclusion criteria

  • {"criterion_text":"- Administration of mTOR inhibitors; everolimus, sirolimus"}
  • {"criterion_text":"- Quadruple immunosuppression"}
  • {"criterion_text":"- Renal transplantation"}
  • {"criterion_text":"- The subject has any disease or condition that might interfere with completion of this study or reaching the primary endpoint (e.g., life expectancy of <3 years, renal replacement therapy at start study"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Kidney function","definition_or_measurement_approach":"Absolute difference in renal function expressed as absolute difference in eGFR at 2 years compared to baseline, calculated by the 2012 CKD-EPI creatinine–cystatin C equation."}

Secondary endpoints

  • {"endpoint_text":"- The key secondary objective is graft function. Other secondary endpoints are changes in known side effects of calcineurin inhibitors i.e. hypertension, new onset diabetes mellitus and neurotoxicity.","definition_or_measurement_approach":"Not specified in detail in the record; described as graft function and changes in known side effects (hypertension, new onset diabetes mellitus, neurotoxicity)."}

Recruitment

Registry Or Advocacy Recruitment
True, TransplantLines biobank study (UMCG)
Planned Sample Size
140
Recruitment Window Months
49
Consent Approach
Written informed consent required from participants. Participants are adults (>18 years). No details on assent, age-specific documents or language availability are provided in the record.

Geography

Total Number Of Sites
1
Total Number Of Participants
140

Netherlands

Earliest CTIS Part Ii Submission Date
28-01-2025
Latest Decision Or Authorization Date
28-01-2025
Processing Time Days
0
Number Of Sites
1
Number Of Participants
140

Sites

Site Name
University Medical Center Groningen
Department Name
Respiratory disease, tuberculosis and lung transplantation
Principal Investigator Name
Tji Gan
Principal Investigator Email
c.t.gan@umcg.nl
Contact Person Name
Tji Gan
Contact Person Email
c.t.gan@umcg.nl

Sponsor

Primary sponsor

Full Name
Universitair Medisch Centrum Groningen
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Envarsus 0.75 mg prolonged-release tablets
Active Substance
Tacrolimus
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
10 mg daily (maxDailyDoseAmount)
Investigational Product Name
PROGRAF 1 mg capsule
Active Substance
Tacrolimus
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
10 mg daily (maxDailyDoseAmount)

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