INVESTIGATING NEW ONSET DIABETES MELLITUS IN KIDNEY TRANSPLANT RECIPIENTS RECEIVING AN ADVAGRAF-BASED IMMUNOSUPPRESSIVE REGIMEN WITH OR WITHOUT CORTICOSTEROIDS – A MULTICENTER, TWO ARM, RANDOMIZED, OPEN LABEL CLINICAL STUDY - ADVANCE

• Conditions: Prophylaxis of rejection in kidney allograft recipients (by immunosuppression); MedDRA version: 13.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2010-019638-28-FI
• Lead Sponsor: Astellas Pharma Europe Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-05
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1166

Inclusion Criteria

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 HLA identical) donor with compatible AB0 blood type.
4. Female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study.
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 IUDs, sexual abstinence or vasectomized partner.
5. 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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. Previous renal transplant lost within one year for immunological reasons.
5. Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest).
6. 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.
7. Diagnosis of Diabetes Mellitus prior to transplantation (treated with prescribed
medications or diet controlled) or where there is evidence of a previous positive OGTT in the patients medical history or previous diagnosis of gestational diabetes or Baseline HbA1C =6.5mmol/L.
8. Requiring initial sequential or parallel therapy with immunosuppressive antibody
preparation(s).
9. Requiring ongoing dosing with a systemic immunosuppressive drug prior to
transplantation (e.g. for Lupus Disease, FSGN etc) other than minimal levels of
immunosuppressant following failure of a previous transplantation without nephrectomy.
10. Where Physician considers long term steroid treatment is necessary for the prevention of recurrent auto immune mediated renal disease or if the subject requires ongoing dosing with corticosteroids during the study for any other condition.
11. Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
12. Pregnant woman or breast-feeding mother.
13. Subject or donor known to be HIV positive.
14. Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids,
Basiliximab, mycophenolate mofetil or any of the product excipients.
15. Evidence of malignant disease within the last 5 years other than Basal Cell Carcinoma or Squamous Cell Carcinoma.
16. Currently participating in another clinical trial and/or has taken an investigational drug within 28 days prior to randomization.
17. Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
18. Unlikely to comply with the visits scheduled in the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified