Investigating new onset diabetes mellitus in kidney transplant recipients receiving an Advagraf-based immunosupressive regimen with or without corticosteroids - A multicenter, two arm, randomized, open label clinical study.
- Conditions
- Kidney transplantationtransfer of a healthy kidney in another body with non-functioning kidneys.10029149
- Registration Number
- NL-OMON38176
- Lead Sponsor
- Astellas Pharma B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
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 1 year).
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 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 Intrauterine Devises (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).
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% (highest level within 6 months prior to transplant).
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 patient's medical history or previous diagnosis of gestational diabetes or pre-Baseline HbA1c >= 6.5 %.
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 immunosuppression following failure of 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 enrollment.
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary variable will be the diagnosis of NODAT as per ADA criteria at any<br /><br>point up to 24 weeks after kidney transplantation. </p><br>
- Secondary Outcome Measures
Name Time Method