Evaluation of PK, safety and tolerability with conversion from Prograf to modified release tacrolimus
- Conditions
- iver transplant rejectionMedDRA version: 17.1Level: LLTClassification code 10050434Term: Prophylaxis against liver transplant rejectionSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-001076-22-Outside-EU/EEA
- Lead Sponsor
- Fujisawa Healthcare, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 16
1. Legal guardian has been fully informed and has signed an IRB approved informed consent form/authorization. Patient, ages 7-12, has been fully informed and has signed an IRB approved assent form/authorization.
2. Patient is the recipient of a liver transplant at least six months prior to enrollment.
3. Patient is < 12 years of age.
4. Patient is currently receiving Prograf based (whole mg total daily dose and equivalent AM/PM dosing) immunosuppressive therapy for liver transplantation. Patient is able to swallow whole intact capsules.
5. The total daily dose of each immunosuppression medication (including corticosteroids) has remained unchanged for the last 2 weeks prior to entry into the study. Corticosteroid dose not to exceed 20 mg/day.
6. Patient has stable whole blood trough level concentrations of Prograf (defined as tacrolimus trough concentrations of 5-20 ng/mL measured on at least 2 separate occasions taken at least 6 days apart within 30 days prior to enrollment), and is clinically stable in the opinion of the Investigator.
7. Female patients who have started their menses must have a negative urine or serum pregnancy test within 14 days prior to enrollment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 16
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Patient has previously received an organ transplant other than a liver.
2. Patient has experienced any rejection episode within 90 days prior to enrollment in the study, any rejection episode within the last 6 months that required anti-lymphocyte antibody therapy or more than 2 rejection episodes within the last 12 months.
3. Patient is currently receiving sirolimus immunosuppression therapy.
4. Patient has any unstable medical condition that could interfere with the study objectives.
5. Patient is currently participating in another clinical trial and/or is taking or has been taking an investigational drug in the 30 days prior to enrollment.
6. Patient has a history or presence of malignancy (except for treated basal or squamous cell carcinoma of the skin), serious active or recurrent infection or any medical condition or disorder that, in the opinion of the investigator, precludes the patient from participating in this study.
7. Patient has a known hypersensitivity to tacrolimus.
8. Patient is pregnant or lactating, for female patients who have started their menses.
9. Patient is unlikely to comply with the scheduled visits.
10. Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator.
11. Patient is currently receiving any medications described in Appendix C.
12. Patient’s liver function is abnormal, as defined by AST/ALT > 2 x ULN at screening.
13. Patient’s renal function is abnormal, as defined by calculated creatinine clearance < 50 mL/min/m2 using the Schwartz formula.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine and compare the pharmacokinetics of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release (MR) tacrolimus based immunosuppression regimen.;Secondary Objective: To determine the long-term safety and tolerability of tacrolimus in stable pediatric liver transplant patients converted from a Prograf based immunosuppression regimen to a modified release (MR) tacrolimus based immunosuppression regimen.;Primary end point(s): Cmin, AUC0-24, ;Timepoint(s) of evaluation of this end point: Days 1-7 for Prograf;<br>Days 8-14 for Tacrolimus MR<br><br>AUC0-24: Prograf day 7; tacrolimus MR day 14
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Cmax, Tmax;<br><br>The assessment of safety and tolerability will be based upon clinical signs and<br>symptoms, laboratory parameters, diagnostic tests and other relevant information.;Timepoint(s) of evaluation of this end point: Days 1-7 for Prograf;<br>Days 8-14 for Tacrolimus MR<br><br>Tmax: Prograf day 7; tacrolimus MR day 14<br><br>Safety and tolerability: Day 1, 7, 8, 10, 12, 14, 21, Month 1, 2, 3, 6, 9, 12, 15, 18 , 21, 24