Studying kidney function in patients with a kidney transplant treated with anti-rejection therapy based on Advagraf when used with or without sirolimus.
- Conditions
- Prophylaxis of rejection in kidney allograft recipients (by immunosuppression)MedDRA version: 15.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2010-019639-37-AT
- Lead Sponsor
- Astellas Pharma Europe Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 772
1. Age = 18 years.
2. End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 6 months).
3. Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen identical) donor with compatible ABO blood type.
4. Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment.
5. Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs.
6. Capable of understanding the purpose and risks of the study, fully informed and having given written informed consent (signed Informed Consent has been obtained).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 579
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 193
1. Receiving or having previously received an organ transplant other than a kidney.
2. Cold ischemia time of the donor kidney > 30 hours.
3. Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest).
4. Panel Reactive Antibody >20%.
5. Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels = 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor.
6. Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s).
7. Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (other than minimal levels of immunosuppression following failure of previous transplantation without nephrectomy).
8. Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
9. Pregnant woman or breast-feeding mother.
10. Subject or donor known to be HIV positive.
11. Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, sirolimus, MMF or any of the product excipients or iodine.
12. Evidence of malignant disease within the last 5 years, not including non-malignant skin cancers.
13. Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment.
14. Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator.
15. Unlikely to comply with the visits scheduled in the protocol.
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 effect two immunosuppressive therapy regimens on Glomerular Filtration Rate (GFR) estimated by Iohexol clearance at Week 52 post kidney transplantation.<br>Arm 1: Advagraf® + MMF + Steroids<br>Arm 2: Advagraf® + MMF (withdrawn at Day 28) + Steroids + Sirolimus (introduced at Day 28). At Day 42 (Week 6) the Advagraf® dose will be reduced to achieve lower tacrolimus target levels.;Secondary Objective: To compare the safety and efficacy profiles of the two immunosuppressive therapy regimens with each other;Primary end point(s): GFR estimated by Iohexol clearance at Week 52 post kidney transplantation;Timepoint(s) of evaluation of this end point: week 52
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Efficacy failure. Composite endpoint defined as graft loss or subject withdrawal<br>• GFR and calculated creatinine clearance at Week 52 post kidney transplantation <br>• Incidence and time to clinical acute rejection and Biopsy Confirmed Acute Rejection<br>(BCAR)<br>• Delayed Graft Function (DGF)<br>• Subject and graft survival<br>• New Onset Diabetes Mellitus (NODM) as per American Diabetic Association (ADA) criteria;Timepoint(s) of evaluation of this end point: Up to week 52