Kidney TransplantationPhase 4ADVANCENCT01304836
A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids
A Phase 4 study testing Advagraf, Mycophenolate Mofetil and Simulect in people with Kidney Transplantation, run by Astellas Pharma Inc at 100 sites in 24 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Advagraf, Mycophenolate Mofetil and Simulect
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,166 participants
- Where
- 100 sitesin 24 countries
- Study dates
- 22 Jan 2011to 22 May 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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)
Show all 23Show fewer
- 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
Trial locations and contacts
100 sites in 24 countries.
100 sites in 24 countries
France12 sites
Study site
Bordeaux, 33076
Study site
Cité Nord, 42270
Study site
D'Angers, 49033
Study site
Le Puytren, 87042
Study site
Montpellier, 34295
Study site
Nantes, 49033
Study site
Nice, 06002
Study site
Paris, 75970
Study site
Rennes, 35033
Study site
Rouen, 76320
Study site
Strasbourg, 67091
Study site
Suresnes, 92151
Italy12 sites
Study site
Ancona, 60020
Study site
Bologna, 40138
Study site
Cagliari, 09134
Study site
L’Aquila, 67010
Study site
Milan, 20132
Study site
Milan, 20162
Study site
Padova, 35128
Study site
Pisa, 56124
Study site
Roma, 00133
Study site
Salerno, 84131
Study site
Treviso, 31100
Study site
Vicenza, 36100
Russia11 sites
Study site
Moscow, 115446
Study site
Moscow, 119992
Study site
Moscow, 123182
Study site
Moscow, 129090
Study site
Moscow, 129110
Study site
Nizhny Novgorod, 603001
Study site
Omsk, 644112
Study site
Saint Petersburg, 192242
Study site
Saint Petersburg, 197022
Study site
Vol’skiy, 404120
Study site
Yekaterinburg, 620102
Spain11 sites
Study site
Alicante, 03010
Study site
Barcelona, 08035
Study site
Barcelona, 08916
Study site
Córdoba, 14004
Study site
Madrid, 28034
Study site
Madrid, 28041
Study site
Santa Cruz de Tenerife, 38320
Study site
Seville, 41013
Study site
Toledo, 45004
Study site
Valencia, 46009
Study site
Valladolid, 47011
Germany10 sites
Study site
Aachen, 52074
Study site
Bonn, 53105
Study site
Düsseldorf, 40225
Study site
Essen, 45147
Study site
Halle, 06120
Study site
Kaiserslautern, 67655
Study site
Mannheim, 68167
Study site
München, 81675
Study site
Regensburg, 93053
Study site
Rostock, 18055
Poland5 sites
Study site
Bydgoszcz, 85-094
Study site
Gdansk, 80-952
Study site
Poznan, 60-479
Study site
Szczecin, 70-111
Study site
Warsaw, 02-006
Belgium4 sites
Study site
Brussels, 1090
Study site
Brussels, 1200
Study site
Leuven, 3000
Study site
Liège, 4000
Czechia4 sites
Study site
Brno, 656 91
Study site
Hradec Králové, 50005
Study site
Olomouc, 775 20
Study site
Prague, 140 21
Portugal4 sites
Study site
Coimbra, 3000-075
Study site
Lisbon, 1069-166
Study site
Lisbon, 1649-035
Study site
Porto, 4099-001
South Korea4 sites
Study site
Seoul, 120-752
Study site
Seoul, 135-710
Study site
Seoul, 135-720
Study site
Seoul, 138-736
Australia3 sites
Study site
Perth, 6001
Study site
Sydney, 2050
Study site
Sydney, 2145
Slovakia3 sites
Study site
Banská Bystrica, 975 17
Study site
Bratislava, 833 05
Study site
Košice, 040 66
Sweden3 sites
Study site
Gothenburg, 41345
Study site
Stockholm, 141 86
Study site
Uppsala, 75185
About this study
Official 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
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.
Read the detailed description
The primary objective of this study is to compare an Immunosuppressive regimen with 10 days of corticosteroids with a regimen with only an optional intra-op bolus of corticosteroids with regard to incidence of new onset Diabetes Mellitus as per the American Diabetic Association (ADA) criteria at any point up to 24 weeks after kidney transplantation.
- Conditions
- Kidney Transplantation
- Being tested
- Advagraf, Mycophenolate Mofetil, Simulect, Corticosteroids
- Keywords
- Kidney, Diabetes Mellitus, Transplant, Immunosuppression
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvagrafDrug
Also called FK506E, modified release tacrolimus
oral
Also called CellCept
oral
SimulectDrug
Also called Basiliximab
IV
CorticosteroidsDrug
Also called prednisolone, methylprednisolone
IV \& oral
| Study group | Role | What they receive |
|---|---|---|
| 10 Days of Steroids | Active comparator | Advagraf + Basiliximab + MMF + Steroids (10 days) Receives: Drug: Advagraf; Drug: Mycophenolate Mofetil; Drug: Simulect; Drug: Corticosteroids |
| Optional Steroid bolus only | Experimental | Advagraf + Basiliximab + MMF + Steroids (bolus only) Receives: Drug: Advagraf; Drug: Mycophenolate Mofetil; Drug: Simulect; Drug: Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of new onset Diabetes Mellitus as per ADA criteria at any point up to 24 weeks after kidney transplantation
Measured: up to 6 months
Secondary outcomes (9)
Efficacy failure using a composite endpoint consisting of graft loss, biopsy confirmed acute rejection or graft dysfunction
Measured: up to 6 months
Positive Oral Glucose Tolerance Test
Measured: 8 weeks
Repeat Positive Oral Glucose Tolerance Test
Measured: 6 months
Renal function
Measured: at 6 months
Acute Rejections
Measured: up to 6 months
Biopsy confirmed acute rejections
Measured: up to 6 months
Subject survival
Measured: up to 6 months
Graft survival
Measured: up to 6 months
Change from Baseline in HbA1C levels
Measured: Baseline, week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study start22 Jan 2011
- Primary completion22 May 2013
- Study completion22 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304836
- Sponsor's protocol ID
- PMR-EC-1211
- Other IDs
- 2010-019638-28
- Acronym
- ADVANCE
- Status last verified
- Oct 2024
- First submitted
- 3 Feb 2011
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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/.
Publications
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.
PubMed 27547871
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01304836
- Acronym / sponsor ID
- ADVANCE / PMR-EC-1211
- Conditions
- Kidney Transplantation
- Keywords
- Kidney, Diabetes Mellitus, Transplant, Immunosuppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,166 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2011 (actual)
- Primary completion
- 22 May 2013 (actual)
- Study completion
- 22 May 2013 (actual)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this study is to compare an Immunosuppressive regimen with 10 days of corticosteroids with a regimen with only an optional intra-op bolus of corticosteroids with regard to incidence of new onset Diabetes Mellitus as per the American Diabetic Association (ADA) criteria at any point up to 24 weeks after kidney transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 Days of Steroids | Active comparator | Drug: Advagraf, Drug: Mycophenolate Mofetil, Drug: Simulect, Drug: CorticosteroidsAdvagraf + Basiliximab + MMF + Steroids (10 days) |
| Optional Steroid bolus only | Experimental | Drug: Advagraf, Drug: Mycophenolate Mofetil, Drug: Simulect, Drug: CorticosteroidsAdvagraf + Basiliximab + MMF + Steroids (bolus only) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdvagrafAlso: FK506E, modified release tacrolimusoral | Drug | 10 Days of Steroids, Optional Steroid bolus only |
| Mycophenolate MofetilAlso: CellCeptoral | Drug | 10 Days of Steroids, Optional Steroid bolus only |
| SimulectAlso: BasiliximabIV | Drug | 10 Days of Steroids, Optional Steroid bolus only |
| CorticosteroidsAlso: prednisolone, methylprednisoloneIV \& oral | Drug | 10 Days of Steroids, Optional Steroid bolus only |
Primary outcome
Diagnosis of new onset Diabetes Mellitus as per ADA criteria at any point up to 24 weeks after kidney transplantation
Time frame: up to 6 months
9 secondary outcomes
Efficacy failure using a composite endpoint consisting of graft loss, biopsy confirmed acute rejection or graft dysfunction
Time frame: up to 6 months
Positive Oral Glucose Tolerance Test
Time frame: 8 weeks
Repeat Positive Oral Glucose Tolerance Test
Time frame: 6 months
Renal function
Time frame: at 6 months
Acute Rejections
Time frame: up to 6 months
Biopsy confirmed acute rejections
Time frame: up to 6 months
Subject survival
Time frame: up to 6 months
Graft survival
Time frame: up to 6 months
Change from Baseline in HbA1C levels
Time frame: Baseline, week 12 and week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Derived from this study: PubMed 27547871Mourad 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.
- Individual participant dataSharing planned: Yes. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Use Central Contact study director
Astellas Pharma Europe Ltd.
100 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Advagraf, Mycophenolate Mofetil and Simulect in people with Kidney Transplantation, run by Astellas Pharma Inc at 100 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in France, Italy, Russia, Spain, Germany and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of new onset Diabetes Mellitus as per ADA criteria at any point up to 24 weeks after kidney transplantation (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01304836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.