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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01304836




Registration number
NCT01304836
Ethics application status
Date submitted
3/02/2011
Date registered
28/02/2011

Titles & IDs
Public title
A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids
Scientific title
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
Secondary ID [1] 0 0
2010-019638-28
Secondary ID [2] 0 0
PMR-EC-1211
Universal Trial Number (UTN)
Trial acronym
ADVANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Advagraf
Treatment: Drugs - Mycophenolate Mofetil
Treatment: Drugs - Simulect
Treatment: Drugs - Corticosteroids

Active comparator: 10 Days of Steroids - Advagraf + Basiliximab + MMF + Steroids (10 days)

Experimental: Optional Steroid bolus only - Advagraf + Basiliximab + MMF + Steroids (bolus only)


Treatment: Drugs: Advagraf
oral

Treatment: Drugs: Mycophenolate Mofetil
oral

Treatment: Drugs: Simulect
IV

Treatment: Drugs: Corticosteroids
IV \& oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnosis of new onset Diabetes Mellitus as per ADA criteria at any point up to 24 weeks after kidney transplantation
Timepoint [1] 0 0
up to 6 months
Secondary outcome [1] 0 0
Efficacy failure using a composite endpoint consisting of graft loss, biopsy confirmed acute rejection or graft dysfunction
Timepoint [1] 0 0
up to 6 months
Secondary outcome [2] 0 0
Positive Oral Glucose Tolerance Test
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Repeat Positive Oral Glucose Tolerance Test
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Renal function
Timepoint [4] 0 0
at 6 months
Secondary outcome [5] 0 0
Acute Rejections
Timepoint [5] 0 0
up to 6 months
Secondary outcome [6] 0 0
Biopsy confirmed acute rejections
Timepoint [6] 0 0
up to 6 months
Secondary outcome [7] 0 0
Subject survival
Timepoint [7] 0 0
up to 6 months
Secondary outcome [8] 0 0
Graft survival
Timepoint [8] 0 0
up to 6 months
Secondary outcome [9] 0 0
Change from Baseline in HbA1C levels
Timepoint [9] 0 0
Baseline, week 12 and week 24

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/05/2013
Sample size
Target
Accrual to date
Final
1166
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Perth
Recruitment hospital [2] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Belgium
State/province [4] 0 0
Liege
Country [5] 0 0
Colombia
State/province [5] 0 0
Cali
Country [6] 0 0
Czechia
State/province [6] 0 0
Brno
Country [7] 0 0
Czechia
State/province [7] 0 0
Hradec Kralove
Country [8] 0 0
Czechia
State/province [8] 0 0
Olomouc
Country [9] 0 0
Czechia
State/province [9] 0 0
Prague
Country [10] 0 0
Estonia
State/province [10] 0 0
Tartu
Country [11] 0 0
Finland
State/province [11] 0 0
Helsinki
Country [12] 0 0
France
State/province [12] 0 0
Bordeaux
Country [13] 0 0
France
State/province [13] 0 0
Cite Nord
Country [14] 0 0
France
State/province [14] 0 0
D'Angers
Country [15] 0 0
France
State/province [15] 0 0
Le Puytren
Country [16] 0 0
France
State/province [16] 0 0
Montpellier
Country [17] 0 0
France
State/province [17] 0 0
Nantes
Country [18] 0 0
France
State/province [18] 0 0
Nice
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
France
State/province [20] 0 0
Rennes
Country [21] 0 0
France
State/province [21] 0 0
Rouen
Country [22] 0 0
France
State/province [22] 0 0
Strasbourg
Country [23] 0 0
France
State/province [23] 0 0
Suresnes
Country [24] 0 0
Germany
State/province [24] 0 0
Aachen
Country [25] 0 0
Germany
State/province [25] 0 0
Bonn
Country [26] 0 0
Germany
State/province [26] 0 0
Düsseldorf
Country [27] 0 0
Germany
State/province [27] 0 0
Essen
Country [28] 0 0
Germany
State/province [28] 0 0
Halle Saale
Country [29] 0 0
Germany
State/province [29] 0 0
Kaiserslautern
Country [30] 0 0
Germany
State/province [30] 0 0
Mannheim
Country [31] 0 0
Germany
State/province [31] 0 0
Muenchen
Country [32] 0 0
Germany
State/province [32] 0 0
Regensburg
Country [33] 0 0
Germany
State/province [33] 0 0
Rostock
Country [34] 0 0
Hungary
State/province [34] 0 0
Debrecen
Country [35] 0 0
Hungary
State/province [35] 0 0
Szeged
Country [36] 0 0
Italy
State/province [36] 0 0
Ancona
Country [37] 0 0
Italy
State/province [37] 0 0
Bologna
Country [38] 0 0
Italy
State/province [38] 0 0
Cagliari
Country [39] 0 0
Italy
State/province [39] 0 0
L'Aquila
Country [40] 0 0
Italy
State/province [40] 0 0
Milano
Country [41] 0 0
Italy
State/province [41] 0 0
Padova
Country [42] 0 0
Italy
State/province [42] 0 0
Pisa
Country [43] 0 0
Italy
State/province [43] 0 0
Roma
Country [44] 0 0
Italy
State/province [44] 0 0
Salerno
Country [45] 0 0
Italy
State/province [45] 0 0
Treviso
Country [46] 0 0
Italy
State/province [46] 0 0
Vicenza
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Seoul
Country [48] 0 0
Latvia
State/province [48] 0 0
Riga
Country [49] 0 0
Lithuania
State/province [49] 0 0
Vilnius
Country [50] 0 0
Mexico
State/province [50] 0 0
Cuernavaca
Country [51] 0 0
Mexico
State/province [51] 0 0
Mexico City
Country [52] 0 0
Netherlands
State/province [52] 0 0
Maastricht
Country [53] 0 0
Norway
State/province [53] 0 0
Olso
Country [54] 0 0
Poland
State/province [54] 0 0
Bydgoszcz
Country [55] 0 0
Poland
State/province [55] 0 0
Gdansk
Country [56] 0 0
Poland
State/province [56] 0 0
Poznan
Country [57] 0 0
Poland
State/province [57] 0 0
Szczecin
Country [58] 0 0
Poland
State/province [58] 0 0
Warszawa
Country [59] 0 0
Portugal
State/province [59] 0 0
Coimbra
Country [60] 0 0
Portugal
State/province [60] 0 0
Lisboa
Country [61] 0 0
Portugal
State/province [61] 0 0
Porto
Country [62] 0 0
Romania
State/province [62] 0 0
Bucharest
Country [63] 0 0
Romania
State/province [63] 0 0
Lasi
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Ekaterinburg
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Moscow
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Nizhniy Novgorod
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Omsk
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Saint-Petersburg
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Vol'skiy
Country [70] 0 0
Slovakia
State/province [70] 0 0
Banska Bystrica
Country [71] 0 0
Slovakia
State/province [71] 0 0
Bratislava
Country [72] 0 0
Slovakia
State/province [72] 0 0
Kosice
Country [73] 0 0
Spain
State/province [73] 0 0
Alicante
Country [74] 0 0
Spain
State/province [74] 0 0
Barcelona
Country [75] 0 0
Spain
State/province [75] 0 0
Cordoba
Country [76] 0 0
Spain
State/province [76] 0 0
Madrid
Country [77] 0 0
Spain
State/province [77] 0 0
Santa Cruz de Tenerife
Country [78] 0 0
Spain
State/province [78] 0 0
Sevilla
Country [79] 0 0
Spain
State/province [79] 0 0
Toledo
Country [80] 0 0
Spain
State/province [80] 0 0
Valencia
Country [81] 0 0
Spain
State/province [81] 0 0
Valladolid
Country [82] 0 0
Sweden
State/province [82] 0 0
Goteborg
Country [83] 0 0
Sweden
State/province [83] 0 0
Stockholm
Country [84] 0 0
Sweden
State/province [84] 0 0
Uppsala
Country [85] 0 0
Switzerland
State/province [85] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Use Central Contact
Address 0 0
Astellas Pharma Europe Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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/.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicaltrials.astellas.com/transparency/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01304836