A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids
ADVANCE
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
2 other identifiers
interventional
1,166
23 countries
99
Brief Summary
The purpose of this study is to focus on potential differences in the occurrence of new-onset Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of immunosuppressive treatment are compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2011
Typical duration for phase_4
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2011
CompletedFirst Submitted
Initial submission to the registry
February 3, 2011
CompletedFirst Posted
Study publicly available on registry
February 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2013
CompletedNovember 1, 2024
October 1, 2024
2.3 years
February 3, 2011
October 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnosis of new onset Diabetes Mellitus as per ADA criteria at any point up to 24 weeks after kidney transplantation
up to 6 months
Secondary Outcomes (9)
Efficacy failure using a composite endpoint consisting of graft loss, biopsy confirmed acute rejection or graft dysfunction
up to 6 months
Positive Oral Glucose Tolerance Test
8 weeks
Repeat Positive Oral Glucose Tolerance Test
6 months
Renal function
at 6 months
Acute Rejections
up to 6 months
- +4 more secondary outcomes
Study Arms (2)
10 Days of Steroids
ACTIVE COMPARATORAdvagraf + Basiliximab + MMF + Steroids (10 days)
Optional Steroid bolus only
EXPERIMENTALAdvagraf + Basiliximab + MMF + Steroids (bolus only)
Interventions
oral
IV \& oral
Eligibility Criteria
You may qualify if:
- End stage kidney disease and a suitable candidate for primary
- 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
You may not qualify if:
- Receiving or having previously received an organ transplant
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (100)
Unknown Facility
Perth, 6001, Australia
Unknown Facility
Sydney, 2050, Australia
Unknown Facility
Sydney, 2145, Australia
Unknown Facility
Brussels, 1090, Belgium
Unknown Facility
Brussels, 1200, Belgium
Unknown Facility
Leuven, 3000, Belgium
Unknown Facility
Liège, 4000, Belgium
Unknown Facility
Cali, 760032, Colombia
Unknown Facility
Brno, 656 91, Czechia
Unknown Facility
Hradec Králové, 50005, Czechia
Unknown Facility
Olomouc, 775 20, Czechia
Unknown Facility
Prague, 140 21, Czechia
Unknown Facility
Tartu, 51014, Estonia
Unknown Facility
Helsinki, 02611, Finland
Unknown Facility
Bordeaux, 33076, France
Unknown Facility
Cité Nord, 42270, France
Unknown Facility
D'Angers, 49033, France
Unknown Facility
Le Puytren, 87042, France
Unknown Facility
Montpellier, 34295, France
Unknown Facility
Nantes, 49033, France
Unknown Facility
Nice, 06002, France
Unknown Facility
Paris, 75970, France
Unknown Facility
Rennes, 35033, France
Unknown Facility
Rouen, 76320, France
Unknown Facility
Strasbourg, 67091, France
Unknown Facility
Suresnes, 92151, France
Unknown Facility
Aachen, 52074, Germany
Unknown Facility
Bonn, 53105, Germany
Unknown Facility
Düsseldorf, 40225, Germany
Unknown Facility
Essen, 45147, Germany
Unknown Facility
Halle, 06120, Germany
Unknown Facility
Kaiserslautern, 67655, Germany
Unknown Facility
Mannheim, 68167, Germany
Unknown Facility
München, 81675, Germany
Unknown Facility
Regensburg, 93053, Germany
Unknown Facility
Rostock, 18055, Germany
Unknown Facility
Debrecen, 4032, Hungary
Unknown Facility
Szeged, 6720, Hungary
Unknown Facility
Ancona, 60020, Italy
Unknown Facility
Bologna, 40138, Italy
Unknown Facility
Cagliari, 09134, Italy
Unknown Facility
L’Aquila, 67010, Italy
Unknown Facility
Milan, 20132, Italy
Unknown Facility
Milan, 20162, Italy
Unknown Facility
Padua, 35128, Italy
Unknown Facility
Pisa, 56124, Italy
Unknown Facility
Roma, 00133, Italy
Unknown Facility
Salerno, 84131, Italy
Unknown Facility
Treviso, 31100, Italy
Unknown Facility
Vicenza, 36100, Italy
Unknown Facility
Riga, LV-1002, Latvia
Unknown Facility
Vilnius, LT-08661, Lithuania
Unknown Facility
Cuernavaca, 62448, Mexico
Unknown Facility
Mexico City, 14000, Mexico
Unknown Facility
Maastricht, 6229 HX, Netherlands
Unknown Facility
Olso, 0027, Norway
Unknown Facility
Bydgoszcz, 85-094, Poland
Unknown Facility
Gdansk, 80-952, Poland
Unknown Facility
Poznan, 60-479, Poland
Unknown Facility
Szczecin, 70-111, Poland
Unknown Facility
Warsaw, 02-006, Poland
Unknown Facility
Coimbra, 3000-075, Portugal
Unknown Facility
Lisbon, 1069-166, Portugal
Unknown Facility
Lisbon, 1649-035, Portugal
Unknown Facility
Porto, 4099-001, Portugal
Unknown Facility
Bucharest, 022328, Romania
Unknown Facility
Lasi, 700503, Romania
Unknown Facility
Moscow, 115446, Russia
Unknown Facility
Moscow, 119992, Russia
Unknown Facility
Moscow, 123182, Russia
Unknown Facility
Moscow, 129090, Russia
Unknown Facility
Moscow, 129110, Russia
Unknown Facility
Nizhny Novgorod, 603001, Russia
Unknown Facility
Omsk, 644112, Russia
Unknown Facility
Saint Petersburg, 192242, Russia
Unknown Facility
Saint Petersburg, 197022, Russia
Unknown Facility
Vol’skiy, 404120, Russia
Unknown Facility
Yekaterinburg, 620102, Russia
Unknown Facility
Banská Bystrica, 975 17, Slovakia
Unknown Facility
Bratislava, 833 05, Slovakia
Unknown Facility
Košice, 040 66, Slovakia
Unknown Facility
Seoul, 120-752, South Korea
Unknown Facility
Seoul, 135-710, South Korea
Unknown Facility
Seoul, 135-720, South Korea
Unknown Facility
Seoul, 138-736, South Korea
Unknown Facility
Alicante, 03010, Spain
Unknown Facility
Barcelona, 08035, Spain
Unknown Facility
Barcelona, 08916, Spain
Unknown Facility
Córdoba, 14004, Spain
Unknown Facility
Madrid, 28034, Spain
Unknown Facility
Madrid, 28041, Spain
Unknown Facility
Santa Cruz de Tenerife, 38320, Spain
Unknown Facility
Seville, 41013, Spain
Unknown Facility
Toledo, 45004, Spain
Unknown Facility
Valencia, 46009, Spain
Unknown Facility
Valladolid, 47011, Spain
Unknown Facility
Gothenburg, 41345, Sweden
Unknown Facility
Stockholm, 141 86, Sweden
Unknown Facility
Uppsala, 75185, Sweden
Unknown Facility
Bern, 3010, Switzerland
Related Publications (1)
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.
PMID: 27547871DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma Europe Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2011
First Posted
February 28, 2011
Study Start
January 22, 2011
Primary Completion
May 22, 2013
Study Completion
May 22, 2013
Last Updated
November 1, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.