kidney transplantation
Conditions
Interventions
Trade Name: Prograft
Product Name: Prograft
Pharmaceutical Form: Capsule
Trade Name: Advagraf
Product Name: Advagraf
Pharmaceutical Form: Capsule
Trade Name: Envarsus
Product Name: Envarsus
Pharmace
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria. Subjects are eligible for the study if all of the following apply: 1. Age = 18 years. 2. Kidney transplant at least 12 months prior to enrollment and clinically stable in the opinion of the investigator. 3. Prograft® based immunosuppressive regimen. 4. Prograft® dose unchanged for a minimum of 12 weeks prior to enrollment. 5. Immunosuppressive regimen (combination of medications) remained unchanged for a minimum of 12 weeks prior to enrollment. 6. Female subject of childbearing potential must agree to practice effective birth control during the study. 7. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed Informed Consent Form has been obtained). 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Exclusion Criteria. Subjects will be excluded from participation if any of the following apply: 1. Previously received an organ transplant other than a kidney. 2. Acute rejection episode within 6 months prior to enrolment, or an acute rejection episode within the 12 months prior to enrolment that required anti-lymphocyte antibody therapy. 3. Diagnosis of new-onset malignancy after transplantation, with the exception of basocellular or squamous cell carcinoma of the skin, which have been treated successfully. 4. Known allergy to the study drug or any of its components. 5. Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator. 6. Any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may complicate communication with the investigator. 7. Active participation in another clinical trial. 8. Breast-feeding mother. 10. HIV positive. 11. Unlikely to comply with the visits scheduled in the protocol. 12. Proteinuria > 2 g / 24 hrs. 13. GFR estimated according to MDRD to be 20 % over the 6 months prior to enrolment). 15. Elevated SGPT/ALT and/or SGOT/AST and/or total Bilirubin levels = 2 times the upper value of the normal range of the investigational site. 16. Patient is known to have liver cirrhosis. 17. Previous treatment with Envarsus or Advagraf.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary goal of this study is to investigate if the intra-patient variability in tacrolimus pharmacokinetics is reduced by switching patients from maintenance tacrolimus treatment with tacrolimus-Prograft to either Advagraf or to Envarsus. ;Secondary Objective: Secondary goals are: 1. Study the correlation between CYP3A5 genotype and intra-patient variability of tacrolimus clearance. 2. Study the impact of switching from tacrolimus-Prograft to either of the once daily formulations on patient satisfaction and quality of life. 3. Study the influence of age and gender on intra-patient variability. 4. Study the preference of patients for choice of formulation for continuation after study closure. 5. Study the effect of switching to either of the once daily formulations on incidence of acute rejection, on renal function and on adverse events. ;Primary end point(s): The intra-patient variability of the pharmacokinetics of all three formulations, ;Timepoint(s) of evaluation of this end point: after 6 months treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The correlation between CYP3A5 genotype and intra-patient variability of tacrolimus clearance. 2. The impact of switching from tacrolimus-Prograft to either of the once daily formulations on patient satisfaction and quality of life. 3. The preference of patients for choice of formulation for continuation after study closure. 5. The effect of switching to either of the once daily formulations on incidence of acute rejection, on renal function and on adverse events. ;Timepoint(s) of evaluation of this end point: after 6 months treatment | — |
Countries
Netherlands
Contacts
Public ContactTeun van Gelder
Erasmus MC
Outcome results
None listed