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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01363752




Registration number
NCT01363752
Ethics application status
Date submitted
31/05/2011
Date registered
2/06/2011

Titles & IDs
Public title
A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.
Scientific title
A Multicenter, Two Arm, Randomized, Open Label Clinical Study Investigating Renal Function in an Advagraf® Based Immunosuppressive Regimen With or Without Sirolimus in Kidney Transplant Patients
Secondary ID [1] 0 0
2010-019639-37
Secondary ID [2] 0 0
PMR-EC-1212
Universal Trial Number (UTN)
Trial acronym
ADHERE
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 - Sirolimus
Treatment: Drugs - Corticosteroids

Active comparator: Advagraf + MMF + Steroids - Without sirolimus

Experimental: Advagraf + MMF + Steroids + Sirolimus - With sirolimus; MMF withdrawn on Day 28; Sirolimus introduced on Day 28


Treatment: Drugs: Advagraf
oral

Treatment: Drugs: Mycophenolate Mofetil
oral

Treatment: Drugs: Sirolimus
oral

Treatment: Drugs: Corticosteroids
i.v. and oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glomerular Filtration Rate (GFR) estimated by iohexol clearance at Week 52 post kidney transplantation
Timepoint [1] 0 0
up to 1 year
Secondary outcome [1] 0 0
Efficacy failure
Timepoint [1] 0 0
up to 1 year
Secondary outcome [2] 0 0
GFR at Week 52 post kidney transplantation by Modification Diet in Renal Disease (MDRD) formula
Timepoint [2] 0 0
up to 1 year
Secondary outcome [3] 0 0
GFR at Week 52 post kidney transplantation by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
Timepoint [3] 0 0
up to 1 year
Secondary outcome [4] 0 0
Calculated creatinine clearance at Week 52 post kidney transplantation by Cockcroft and Gault formula
Timepoint [4] 0 0
up to 1 year
Secondary outcome [5] 0 0
Incidence of clinical acute rejection
Timepoint [5] 0 0
up to 1 year
Secondary outcome [6] 0 0
Time to clinical acute rejection
Timepoint [6] 0 0
up to 1 year
Secondary outcome [7] 0 0
Incidence of Biopsy Confirmed Acute Rejection
Timepoint [7] 0 0
up to 1 year
Secondary outcome [8] 0 0
Time to Biopsy Confirmed Acute Rejection
Timepoint [8] 0 0
up to 1 year
Secondary outcome [9] 0 0
Subject survival
Timepoint [9] 0 0
up to 1 year
Secondary outcome [10] 0 0
Graft survival
Timepoint [10] 0 0
up to 1 year
Secondary outcome [11] 0 0
New Onset Diabetes Mellitus (NODM) as per American Diabetic Association (ADA) criteria
Timepoint [11] 0 0
up to 1 year

Eligibility
Key inclusion criteria
* End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 6 months)
* Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen [HLA] identical) donor with compatible ABO blood type
* Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment
* Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. 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
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 (PRA) >20%
* 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
* Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
* Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (other than minimal levels of immunosuppression following failure of previous transplantation without nephrectomy)
* 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, sirolimus, MMF or any of the product excipients or iodine
* Evidence of malignant disease within the last 5 years, not including non-malignant skin cancers
* Currently participating in another clinical trial, and/ or has taken an investigational drug within 28 days prior to enrollment
* 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
8/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/09/2013
Sample size
Target
Accrual to date
Final
853
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
5042 - New Lambton
Recruitment hospital [2] 0 0
5043 - Perth
Recruitment postcode(s) [1] 0 0
NSW 2305 - New Lambton
Recruitment postcode(s) [2] 0 0
WA 6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
Austria
State/province [2] 0 0
Linz
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belarus
State/province [4] 0 0
Minsk
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Belgium
State/province [6] 0 0
Liege 1
Country [7] 0 0
Czechia
State/province [7] 0 0
Brno
Country [8] 0 0
Czechia
State/province [8] 0 0
Ostrava - Poruba
Country [9] 0 0
France
State/province [9] 0 0
Amiens Cedex
Country [10] 0 0
France
State/province [10] 0 0
Brest Cedex 2
Country [11] 0 0
France
State/province [11] 0 0
Clermont-Ferrand Cedex 1
Country [12] 0 0
France
State/province [12] 0 0
Creteil Cedex
Country [13] 0 0
France
State/province [13] 0 0
Dijon
Country [14] 0 0
France
State/province [14] 0 0
Le Kremilin Bicetre Cedex
Country [15] 0 0
France
State/province [15] 0 0
Paris Cedex 15
Country [16] 0 0
France
State/province [16] 0 0
Toulouse Cedex 9
Country [17] 0 0
France
State/province [17] 0 0
Tours cedex 9
Country [18] 0 0
France
State/province [18] 0 0
Vandoeuvre Les Nancy Cedex
Country [19] 0 0
Germany
State/province [19] 0 0
Bochum
Country [20] 0 0
Germany
State/province [20] 0 0
Erlangen
Country [21] 0 0
Germany
State/province [21] 0 0
Essen
Country [22] 0 0
Germany
State/province [22] 0 0
Frankfurt
Country [23] 0 0
Germany
State/province [23] 0 0
Hann.Munden
Country [24] 0 0
Germany
State/province [24] 0 0
Hannover
Country [25] 0 0
Germany
State/province [25] 0 0
Heidelberg
Country [26] 0 0
Germany
State/province [26] 0 0
Kiel
Country [27] 0 0
Germany
State/province [27] 0 0
Leipzig
Country [28] 0 0
Germany
State/province [28] 0 0
Munchen
Country [29] 0 0
Germany
State/province [29] 0 0
Munster
Country [30] 0 0
Hong Kong
State/province [30] 0 0
Hong Kong
Country [31] 0 0
Hungary
State/province [31] 0 0
Budapest
Country [32] 0 0
Italy
State/province [32] 0 0
Palermo
Country [33] 0 0
Italy
State/province [33] 0 0
Roma
Country [34] 0 0
Italy
State/province [34] 0 0
Siena
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Busan
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Daegu
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Seoul
Country [38] 0 0
Netherlands
State/province [38] 0 0
Maastricht
Country [39] 0 0
Poland
State/province [39] 0 0
Katowice
Country [40] 0 0
Poland
State/province [40] 0 0
Lodz
Country [41] 0 0
Poland
State/province [41] 0 0
Poznan
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Kemerovo
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Moscow
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Omsk
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Vol'ginskiy
Country [46] 0 0
Spain
State/province [46] 0 0
Alicante
Country [47] 0 0
Spain
State/province [47] 0 0
Barcelona
Country [48] 0 0
Spain
State/province [48] 0 0
Santander
Country [49] 0 0
Spain
State/province [49] 0 0
Vizcaya
Country [50] 0 0
Taiwan
State/province [50] 0 0
Tainan
Country [51] 0 0
Taiwan
State/province [51] 0 0
Taoyuan
Country [52] 0 0
Turkey
State/province [52] 0 0
Istanbul

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 trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

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.clinicalstudydatarequest.com/


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/NCT01363752