Within-patient variability in tacrolimus pharmacokinetics in renal transplant patients treated with different tacrolimus formulations.
- Conditions
- immunosuppressionrenal transplantation10038430
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
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).
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. Active participation in another clinical trial.
7. Unlikely to comply with the visits scheduled in the protocol.
8.. Previous treatment with Envarsus or Advagraf.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to investigate if the intra-patient<br /><br>variability in tacrolimus pharmacokinetics is reduced by switching patients<br /><br>from maintenance tacrolimus treatment with tacrolimus-Prograft to either<br /><br>Advagraf or to Envarsus. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives are:<br /><br>1. Study the correlation between CYP3A5 genotype and intra-patient variability<br /><br>of tacrolimus clearance.<br /><br>2. Study the impact of switching from Prograft to either of the once daily<br /><br>formulations on patient satisfaction and quality of life.<br /><br>3. Study the influence of age and gender on intra-patient variability.<br /><br>4. Study the preference of patients for choice of formulation for continuation<br /><br>after study closure.<br /><br>5. Study the effect of switching to either of the once daily formulations on<br /><br>incidence of acute rejection, on renal function and on adverse events.<br /><br></p><br>