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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02316938




Registration number
NCT02316938
Ethics application status
Date submitted
16/10/2014
Date registered
10/12/2014
Date last updated
9/10/2018

Titles & IDs
Public title
Assessing DSA Formation, Diabetes, Viral Infections, Structural Kidney Changes With an Everolimus-based Regimen (ADVISE)
Scientific title
Exploring the Impact of de Novo Everolimus on Key Determinants of Long Term Outcome After Kidney Transplantation: NODAT, Viral Infection, DSA, Proteinuria and Graft Histology
Secondary ID [1] 0 0
CRAD001AAU13
Universal Trial Number (UTN)
Trial acronym
ADVISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Everolimus and reduced CNI
Treatment: Drugs - Calcineurin Inhibitor and MPA

Experimental: Everolimus - Treatment not given as part of this substudy, it is given as part of the core CRAD001A2433 study.

Active Comparator: MPA and standard CNI - Treatment not given as part of this substudy, it is given as part of the core CRAD001A2433 study.


Treatment: Drugs: Everolimus and reduced CNI
MTORi inhibitor, given as part of the core CRAD001A2433 study.

Treatment: Drugs: Calcineurin Inhibitor and MPA
Will either be cyclosporine or tacrolimus. Used as standard of care in this patient population, but at a lower dose in the everolimus arm and at a standard dose in the comparator arm. Treatment given as part of the core CRAD001A2433 stud.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Structural kidney damage - Kidney allograft biopsies will be taken at baseline, months 2, 12 and 24 to assess the structural kidney damage using the BANFF 2013 criteria.
Development of structral allograft damage (Banff classification) over 24 months will be compared between treatment groups using modelling techniques that take into account the repeated measures, nature of the data and all available data.
Timepoint [1] 0 0
Baseline to month 24.
Secondary outcome [1] 0 0
Incidence of de novo Donor specific antibodies formation - Serum blood samples analysed to assess presence and evolution of anti HLA donor specific antibodies.
The number and percentage of patients with anti HLA and donor specific antibodies at each study visit will be presented using a generalised linear mixed model framework as well as a Kaplan-Meier curve to portray the change over time.
Timepoint [1] 0 0
Baseline to month 24
Secondary outcome [2] 0 0
Impaired glucose tolerance and new onset diabetes - Subjects' diabetes status is collected at baseline as part of medical history. At month 2, serum blood test taken pre glucose drink and 2 hours post glucose drink. Subjets classified based on the level of glucose as: No diabetes (fasting plasma glucose <6.1mmol/L or 2 hour OGTT <7.8mmol/L) Prediabetes (fasting plasma glucose 6.1-6.9mmol/L or 2hr OGTT 7.8-11mmol/L) Diabetes (fasting plasma glucose >/= 7.0mmol/L or 2hr OGTT >/= 11.1mmol/L) Shift tables will present the change in diabetes status between baseline and month 2. The odds of becoming diabetic by month 2 (new onset diabetes) will be compared using a generalised linear model, in particular logisitc regression.
Timepoint [2] 0 0
Month 2
Secondary outcome [3] 0 0
Correlation between HbA1c and oral glucose tolerance test - Serum blood samples are taken pre and post glucose drink at month 2. Results are produced for plasma glucose levels and HbA1c in mmol/L. Correlation between the results will be investigated using a generalised linear model.
Timepoint [3] 0 0
Month 2
Secondary outcome [4] 0 0
Development of biochemical markers of viral infections - Blood samples are analysed at baseline months 2, 12 and 24. The following viral loads are measured in copies per ml: CMV (Cytomegalo virus) via PCR BK viremia via RT-PCR EBV (Epstein Barr Virus) via PCR Descriptive staistics will be presented for the viral load of each of the biochemical markers at each timepoint.
Timepoint [4] 0 0
Baseline - month 24

Eligibility
Key inclusion criteria
1. Currently randomized in study CRAD001A2433.

2. Written informed consent for CRAD001AAU13 must be obtained before any assessment is
performed
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients for which the investigator believes performing protocol required biopsies will
place the patient at unacceptable level of risk.

Study design
Purpose of the study
Other
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Camperdown
Recruitment hospital [2] 0 0
Novartis Investigative Site - Randwick
Recruitment hospital [3] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [4] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [5] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [6] 0 0
Novartis Investigative Site - Heidelberg Heights
Recruitment hospital [7] 0 0
Novartis Investigative Site - Parkville,
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [7] 0 0
3065 - Parkville,

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
CRAD001AAU13 is a substudy of CRAD001A2433. The core study CRAD001A2433 is a 2-year,
randomized, multicenter, open-label, 2-arm study evaluating graft function with everolimus
and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
Patients in this study may use cyclosporine or tacrolimus as the CNI.
Trial website
https://clinicaltrials.gov/show/NCT02316938
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

Summary results
Other publications