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

Conditions
Effect of immunosuppressive medication on renal function following livertransplantation
MedDRA version: 9.1Level: LLTClassification code 10024716Term: Liver transplantation
Registration Number
EUCTR2008-000627-26-NL
Lead Sponsor
eiden University Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
50
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

Multi-organ transplant recipients
Allergy/intollerance to the study drugs
Patients with a serum creatinine >200 umol/l
Pregnant or breastfeading mother

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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