Study to investigate the safety and efficacy of tacrolimus in kidney transplant recipients
- Conditions
- Kidney transplant recipientsMedDRA version: 18.0Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-003288-12-Outside-EU/EEA
- Lead Sponsor
- Fujisawa Healthcare, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 660
1. Patient has been fully informed and has signed an IRB approved informed
consent/authorization form and is willing and able to follow study procedures.
2. Patient is a recipient of a primary or retransplanted
cadaveric or non-HLA-identical living kidney
transplant.
3. Patient is age greater or equal to 12 years.
4. Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure.
5. 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: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 658
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 AL T (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, cyc1osporine,
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.
14. Patient has received a kidney with a cold
ischemia time of;::: 36 hours
15. Patient has received a kidney transplant
from a cadaveric donor;::: 60 years of age
16. Patient received IVIG therapy prior to
randomization
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 ofPrograf®/MMF and<br>Neoral®/MMF in de novo kidney transplant recipients.<br>To compare the safety and efficacy of Modified Release (MR)<br>Tacrolimus/MMF and Neoral®/MMF in de novo kidney transplant<br>recipients.;Secondary Objective: To compare the safety and efficacy of Modified Release (MR)<br>Tacrolimus/MMF and Prograf®/MMF in de novo kidney transplant<br>recipients.;Primary end point(s): Efficacy failure rate.;Timepoint(s) of evaluation of this end point: 1 year
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Incidence of biopsy confirmed acute rejection (Banff Grade 2: I) <br>• Requirement of anti -lymphocyte antibody therapy for treatment of rej ection<br>• Severity of acute rejection<br>• Patients experiencing multiple rejection episodes<br>• Clinically treated acute rejection episodes<br>• Treatment failure<br>• Crossover for treatment failure<br>• Renal function (by calculated creatinine clearance and serum creatinine)<br>• patient and graft survival rates;Timepoint(s) of evaluation of this end point: 6 months<br>12 months<br>2 years<br>3 years<br><br>Time to first acute rejection episode<br>