Comparison of the safety and efficacy of Prograf and Prograf XL in kidney transplantatio
- Conditions
- De novo Kidney Transplant RecipientsMedDRA version: 18.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-002886-53-Outside-EU/EEA
- Lead Sponsor
- Astellas Pharma Taiwan, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 60
- Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living kidney transplant.
- Patient is age greater or equal to 12 years.
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1. Patient has previously received or is receiving an organ transplant other than a kidney.
2. Patient has received a kidney transplant from a non-heart beating donor.
3. Patient has received an ABO incompatible donor kidney.
4. Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
5. Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
6. Patient has significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site.
7. Patient has an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
8. Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant.
9. Patient is receiving everolimus or enteric coated mycophenolic acid at any time during the study.
10. Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil or corticosteroids.
11. Patient is pregnant or lactating.
12. Patient is unlikely to comply with the visits scheduled in the protocol.
13. 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the safety and efficacy of Prograf® /MMF and Extended Release (XL) Tacrolimus /MMF in de novo kidney transplant recipients.;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy endpoint of this study is the patient and graft survival rate at 6 months.;Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Until 12 months;Secondary end point(s): • Efficacy failure at 6 and 12 month posttransplant.<br>• Incidence of biopsy confirmed acute rejection (Banff Grade > I) at 6 and 12 months<br>• Time to first acute rejection episode<br>• Requirement of anti-lymphocyte antibody therapy for treatment of rejection<br>• Severity of acute rejection<br>• Multiple rejection episodes<br>• Clinically treated acute rejection episodes<br>• Treatment failure (up to 12 months) – see Section 7.6<br>• Renal function (by calculated creatinine clearance and serum creatinine)<br>• 1 year patient and graft survival