A multicenter, two arm, randomized, open label clinical study investigating renal function in an advagraf®-based immunosupressive regimen with or without sirolimus in kidney transplant subjects.

Phase 4

Completed

Conditions: Kidney transplantation
transfer of a healthy kidney in another body with non-functioning kidneys.
10029149

Registration Number: NL-OMON38063

Lead Sponsor: Astellas Pharma B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Subject is eligible for the study if all of the following apply:
1. Age >= 18 years.
2. End stage kidney disease and a suitable candidate for primary renal transplantation or retransplantation (unless the graft was lost from rejection within 6 months).
3. Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen [HLA] 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. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ ICH/286/ 95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner.
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).

Exclusion Criteria

Subject will be excluded from participating if any of the following apply:
1. Receiving or having previously received an organ transplant other than a kidney.
2. Cold ischemia time of the donor kidney > 30 hours.
3. Panel Reactive Antibody (PRA) >20%.
4. Receiving a graft from a non-heart-beating donor other than of Maastricht category 3
(withdrawal of support awaiting cardiac arrest).
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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary variable:<br /><br>GFR estimated by iohexol clearance at Week 52 post kidney transplantation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary efficacy variabeles:<br /><br>-Efficacy failure. Composite endpoint defined as graft loss<br /><br>(re-transplantation, nephrectomy, death or dailysis ongoing at the study end)<br /><br>or subject withdrawal.<br /><br>- GFR and calculated creatinine clearance at Week 52 post kidney<br /><br>transplantation by Modification Diet in Renal Disease (MDRD) formula/ Cockcroft<br /><br>and Gault/ Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).<br /><br>- Incidence and time to clinical acute rejection and Biopsy Confirmed Acute<br /><br>Rejection (BCAR).<br /><br>- Delayed Graft Function (DGF).<br /><br>- Subject and graft surivival.<br /><br>- New Onset Diabetis Mellitus (NODM) as per American Diabetic Association (ADA)<br /><br>criteria. </p><br>