Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients
- Conditions
- Immunosuppression in recipients of primary renal transplant10038365
- Registration Number
- NL-OMON44149
- Lead Sponsor
- Chiesi Farmaceutici
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 12
1. Patient's signed informed consent obtained prior to any study-related
procedure;
2. Adult men and women at least 18 years of age with end-stage renal
disease who are recipients of a kidney transplant from a living or
deceased donor;
3. No known contraindications to the administration of tacrolimus, other
macrolides and study drugs excipients;
4. Patients must agree to use a highly reliable method of birth control;
5. Donor-recipient negative cross match test, and compatible ABO blood
type;
6. Able to swallow tablets and capsules.
1. Recipient of any transplanted organ other than kidney;
2. Recipient of a previous renal transplant;
3. Recipient of a kidney from a donor after cardiac death;
4. Recipient of a kidney from an ABO incompatible donor and positive
cross-match donor;
5. Current anti-HLA Panel Reactive Antibody (PRA) levels higher than
30%;
6. Recipient of a kidney with a cold ischemia time of * 30 hours;
7. White blood cells count * 2.8x109 cells/L unless ANC >1.0x109/L;
8. Platelet count < 50 x109 cells/L;
9. ALT or AST levels >3 times the normal upper limit during the 30 days
prior transplant procedure;
10. Current abuse of drugs or alcohol;
11. Incapable of understanding purpose and risk of study, unable to give
written informed consent or unwilling to comply with study protocol;
12. Treatment with any other investigational agent in the 30 days prior
to enrolment;
13. Kidney recipients and/or donors positive for HCV (HCV-RNA positive
or HCV-Ab positive respectively);
14. Kidney recipients and/or donors positive for HBV (HBV-DNA and/or
HBS-Ag positive);
15. Recipients positive for HIV;
16. Patient or donor with current diagnosis or history of malignancy
within the past 5 years except basal or non-metastatic squamous cell
carcinoma of the skin successfully treated;
17. Uncontrolled concomitant infection, systemic infection requiring
treatment or any other unstable condition that could interfere with study
objectives;
18. Severe diarrhoea, vomiting, active peptic ulcer or GI disorder that
may affect absorption of tacrolimus;
19. Known hypersensitivity to tacrolimus; other macrolides and study
drugs excipients
20. Pregnant or lactating women and all women physiologically capable
of becoming pregnant (i.e. women of childbearing potential) UNLESS are
willing to use one or more reliable methods of contraception.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficacy variable<br /><br>The average tacrolimus total daily dose (TDD) from week 3 (V9) to month 6 (V15)<br /><br>will be compared applying an ANOVA model with treatment and country as fixed<br /><br>effect. Adjusted mean and adjusted mean difference will be displayed with<br /><br>corresponding 2-sided 95% CI.</p><br>
- Secondary Outcome Measures
Name Time Method