Conversion from cyclosporine to tacrolimus followed by randomized C0 or Bayesian monitoring using the C4 timepoint The effect on kidney function - FK04-study

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000627-26-NL

Enrollment

Registered

2008-05-29

Start date

2008-09-29

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Effect of immunosuppressive medication on renal function following livertransplantation MedDRA version: 9.1 Level: LLT Classification code 10024716 Term: Liver transplantation

Interventions

Trade Name: Prograf(t) Product Name: Prograft Pharmaceutical Form: Capsule, hard INN or Proposed INN: TACROLIMUS CAS Number: 104987113 Current Sponsor code: FK506 Other descriptive name: Prograf(t) Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Livertransplant recipients at least 18 years of age at least 6 months past last transplantation on a stable calcineurin inhibitor based immunosuppressive regimen capable of understanding the purpose and risk of the study. 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: Multi-organ transplant recipients Allergy/intollerance to the study drugs Patients with a serum creatinine >200 umol/l Pregnant or breastfeading mother

Design outcomes

Primary

Measure	Time frame
Main Objective: Change in cratinine clearance measured by creatinine clearence in 24 hours urine collection and serum creatinine between baseline and week 12, week 12 and 14, and baseline and week 24 ;Secondary Objective: - Changes in mean arterial blood pressure and number and dose of antihypertensive medications used between baseline and week 12 and baseline and week 24 - Tacrolimus pharmacokinetics - Changes in mean lipid levels (total cholesterol, TG, LDL, HDL), and the number and dose of lipid-lowering medications between baseline and week 12 and week 24 - Subject and graft survival - Creatinine clearance calculated by BSA corrected Cockcroft and GAult and MDRD - Biopsy proven treated graft rejection - Side effects;Primary end point(s): Change in renal function, as measured by: Creatinine clearance, measured by creatinine clearance in a 24 hour urine collection and serum creatinine between: 1) baseline and week 12, 2) week 12 and week 24 and 3) baseline and week 24 Creatinine clearance calculated by BSA adjusted Cockcroft and Gault and MDRD	—

Measure

Time frame

Main Objective: Change in cratinine clearance measured by creatinine clearence in 24 hours urine collection and serum creatinine between baseline and week 12, week 12 and 14, and baseline and week 24 ;Secondary Objective: - Changes in mean arterial blood pressure and number and dose of antihypertensive medications used between baseline and week 12 and baseline and week 24 - Tacrolimus pharmacokinetics - Changes in mean lipid levels (total cholesterol, TG, LDL, HDL), and the number and dose of lipid-lowering medications between baseline and week 12 and week 24 - Subject and graft survival - Creatinine clearance calculated by BSA corrected Cockcroft and GAult and MDRD - Biopsy proven treated graft rejection - Side effects;Primary end point(s): Change in renal function, as measured by: Creatinine clearance, measured by creatinine clearance in a 24 hour urine collection and serum creatinine between: 1) baseline and week 12, 2) week 12 and week 24 and 3) baseline and week 24 Creatinine clearance calculated by BSA adjusted Cockcroft and Gault and MDRD

—

Countries

Netherlands

Outcome results

None listed

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