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Conversion from a twice-daily tacrolimus (tac) regimen to a once-daily tacorlimus exended-release formulation (TacXL) regimen : Pharamcokinetic studies in stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant - Tac-XL

Conversion from a twice-daily tacrolimus (tac) regimen to a once-daily tacorlimus exended-release formulation (TacXL) regimen : Pharamcokinetic studies in stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant - Tac-XL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-014050-15-BE
Enrollment
20
Registered
2009-09-14
Start date
2009-09-18
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant MedDRA version: 12.0 Level: LLT Classification code 10025127 Term: Lung transplant

Interventions

Trade Name: Prograft capsules Product Name: Tacrolimus capsules Pharmaceutical Form: Capsule, hard INN or Proposed INN: TACROLIMUS CAS Number: 104987113 Concentration unit: mg milligram(s) Concentrati

Sponsors

Hopital Erasme - Chest service
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - stable CF and non-CF patients having received a pulmonary transplant who did not represent an acute rejection during the 12 months before study entry -patients who present with a normal or only moderate altered renal function (creatinine clearance > 50ml/dl) - written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - patients on medications known to interfere with Tac metabolism (ie. isoniazide, rifampicin, aticonvulsivants, azole anti-fungal agents).

Design outcomes

Primary

MeasureTime frame
Main Objective: To asses PK parameters for Tac-XL versus conventional Tac in stable CF and non-CF lung transplant patients.;Secondary Objective: To assess the intra-individual reproducibility of these PK data obtained with Tac-XL and Tac. To asses safety in terms of graft function and side effects;Primary end point(s): - Asses PK parameters - compare inter and intra-individual variability of the PK data achieved with the two formulations—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026