A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids
NCT ID: NCT01304836
Last Updated: 2024-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1166 participants
INTERVENTIONAL
2011-01-22
2013-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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10 Days of Steroids
Advagraf + Basiliximab + MMF + Steroids (10 days)
Advagraf
oral
Mycophenolate Mofetil
oral
Simulect
IV
Corticosteroids
IV \& oral
Optional Steroid bolus only
Advagraf + Basiliximab + MMF + Steroids (bolus only)
Advagraf
oral
Mycophenolate Mofetil
oral
Simulect
IV
Corticosteroids
IV \& oral
Interventions
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Advagraf
oral
Mycophenolate Mofetil
oral
Simulect
IV
Corticosteroids
IV \& oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
kidney transplantation or re-transplantation (unless the graft was
lost from rejection within one year)
* Receiving a kidney transplant from a deceased or living (non
Human Leukocyte Antigen identical) donor with compatible AB0 blood type
* 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
Exclusion Criteria
other than a kidney
* Cold ischemia time of the donor kidney \> 30 hours
* Panel Reactive Antibody \>20% (Highest level in 6 months prior to transplant)
* Previous renal transplant lost within one year for immunological reasons
* Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest)
* 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
* Diagnosis of Diabetes Mellitus prior to transplantation (treated with prescribed medications or diet controlled) or where there is evidence of a previous positive Oral Glucose Tolerance Test (OGTT) in the patients medical history or previous diagnosis of gestational diabetes or pre-baseline HbA1C ≥6.5%
* Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s).
* 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
* 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
* Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
* Pregnant woman or breast-feeding mother
* Subject or donor known to be HIV positive
* Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab, mycophenolate mofetil or any of the product excipients
* Evidence of malignant disease within the last 5 years other than Basal Cell Carcinoma or Squamous Cell Carcinoma
* Currently participating in another clinical trial and/or has taken an investigational drug within 28 days prior to randomization
* Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
* Unlikely to comply with the visits scheduled in the protocol
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Europe Ltd.
Locations
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Perth, , Australia
Sydney, , Australia
Sydney, , Australia
Brussels, , Belgium
Brussels, , Belgium
Leuven, , Belgium
Liège, , Belgium
Cali, , Colombia
Brno, , Czechia
Hradec Králové, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Tartu, , Estonia
Helsinki, , Finland
Bordeaux, , France
Cité Nord, , France
D'Angers, , France
Le Puytren, , France
Montpellier, , France
Nantes, , France
Nice, , France
Paris, , France
Rennes, , France
Rouen, , France
Strasbourg, , France
Suresnes, , France
Aachen, , Germany
Bonn, , Germany
Düsseldorf, , Germany
Essen, , Germany
Halle, , Germany
Kaiserslautern, , Germany
Mannheim, , Germany
München, , Germany
Regensburg, , Germany
Rostock, , Germany
Debrecen, , Hungary
Szeged, , Hungary
Ancona, , Italy
Bologna, , Italy
Cagliari, , Italy
L’Aquila, , Italy
Milan, , Italy
Milan, , Italy
Padua, , Italy
Pisa, , Italy
Roma, , Italy
Salerno, , Italy
Treviso, , Italy
Vicenza, , Italy
Riga, , Latvia
Vilnius, , Lithuania
Cuernavaca, , Mexico
Mexico City, , Mexico
Maastricht, , Netherlands
Olso, , Norway
Bydgoszcz, , Poland
Gdansk, , Poland
Poznan, , Poland
Szczecin, , Poland
Warsaw, , Poland
Coimbra, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Bucharest, , Romania
Lasi, , Romania
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Omsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Vol’skiy, , Russia
Yekaterinburg, , Russia
Banská Bystrica, , Slovakia
Bratislava, , Slovakia
Košice, , Slovakia
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Alicante, , Spain
Barcelona, , Spain
Barcelona, , Spain
Córdoba, , Spain
Madrid, , Spain
Madrid, , Spain
Santa Cruz de Tenerife, , Spain
Seville, , Spain
Toledo, , Spain
Valencia, , Spain
Valladolid, , Spain
Gothenburg, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Bern, , Switzerland
Countries
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References
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Mourad G, Glyda M, Albano L, Viklicky O, Merville P, Tyden G, Mourad M, Lohmus A, Witzke O, Christiaans MHL, Brown MW, Undre N, Kazeem G, Kuypers DRJ; Advagraf-based immunosuppression regimen examining new onset diabetes mellitus in kidney transplant recipients (ADVANCE) study investigators. Incidence of Posttransplantation Diabetes Mellitus in De Novo Kidney Transplant Recipients Receiving Prolonged-Release Tacrolimus-Based Immunosuppression With 2 Different Corticosteroid Minimization Strategies: ADVANCE, A Randomized Controlled Trial. Transplantation. 2017 Aug;101(8):1924-1934. doi: 10.1097/TP.0000000000001453.
Related Links
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Link to results on the Astellas Clinical Study Results website.
Other Identifiers
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2010-019638-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PMR-EC-1211
Identifier Type: -
Identifier Source: org_study_id
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