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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02191150




Registration number
NCT02191150
Ethics application status
Date submitted
7/07/2014
Date registered
16/07/2014
Date last updated
8/02/2016

Titles & IDs
Public title
Study of Haemodialysis Patients Switching From Aranesp to Biosimilar
Scientific title
Retrospective Study of Stable Haemodialysis Patients Switched From Darbepoetin Alfa to Epoetin Alfa Biosimilar
Secondary ID [1] 0 0
20130300
Universal Trial Number (UTN)
Trial acronym
SHADE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cohort 1 - Patients with CKD
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Haemoglobin Concentration
Timepoint [1] 0 0
Duration of observation period -52 weeks
Secondary outcome [1] 0 0
ESA Doses
Timepoint [1] 0 0
Duration of observation period -52 weeks
Secondary outcome [2] 0 0
Dose ratio
Timepoint [2] 0 0
Start post-switch (weeks 1-4) and pre-switch (weeks -4--1)
Secondary outcome [3] 0 0
Dose ratio
Timepoint [3] 0 0
Between end of post-switch (weeks 23-26) and pre-switch (weeks -4--1)
Secondary outcome [4] 0 0
Haemoglobin excursions
Timepoint [4] 0 0
Duration of observation period -52 weeks
Secondary outcome [5] 0 0
Haemglobin within range
Timepoint [5] 0 0
Duration of observation period -52 weeks
Secondary outcome [6] 0 0
TSAT, ferritin and albumin values
Timepoint [6] 0 0
Duration of observation period -52 weeks
Secondary outcome [7] 0 0
Iron Use
Timepoint [7] 0 0
Duration of observation period -52 weeks
Secondary outcome [8] 0 0
Red cell transfusions (including number of units transfused)
Timepoint [8] 0 0
Duration of observation period -52 weeks
Secondary outcome [9] 0 0
Hospitalisations (including primary cause)
Timepoint [9] 0 0
Duration of observation period -52 weeks

Eligibility
Key inclusion criteria
Inclusion Criteria

- Patients =18 years of age

- Patients with CKD on haemodialysis and fulfilling the following:

- Received HD for at least 26 weeks prior to switching from treatment with
darbepoetin alfa to treatment with an EMA/TGA-approved epoetin alfa biosimilar

- Received darbepoetin alfa treatment i.v. for at least 26 weeks immediately prior
to switching to an EMA/TGA-approved epoetin alfa biosimilar (breaks due to
treatment being intentionally withheld are permitted)

- Switched from darbepoetin alfa treatment to an EMA/TGA-approved epoetin alfa
biosimilar at least 26 weeks prior to enrolment

- Received at least one dose of an EMA/TGA-approved epoetin alfa biosimilar after
switching from darbepoetin alfa treatment

- Mean monthly Hb 10-12g/dL in the 12 weeks prior to switch

- Stable darbepoetin alfa dose (i.e. no more than one increment or decrement of PFS) in
the 12 weeks prior to switch

- Patient or patient's legally acceptable representative has provided informed consent,
if applicable according to local requirements
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Treatment with an ESA other than darbepoetin alfa during the 12 weeks prior to switch
to biosimilar

- More than 14 days' cumulative treatment with short-acting ESA during weeks 26-13 prior
to switch to biosimilar

- Subject received chemotherapy or major surgery during the 26 weeks prior to switch to
biosimilar

- Subject was enrolled in an interventional device or drug study at any time during the
52-week data observation period or within 30 days prior to commencement of the data
observation period.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
272
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Research Site - Herston
Recruitment hospital [2] 0 0
Research Site - Nambour
Recruitment hospital [3] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4560 - Nambour
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Burgas
Country [2] 0 0
Germany
State/province [2] 0 0
Lemgo
Country [3] 0 0
Germany
State/province [3] 0 0
Lich
Country [4] 0 0
Germany
State/province [4] 0 0
Minden
Country [5] 0 0
Greece
State/province [5] 0 0
Egaleo, Athens
Country [6] 0 0
Greece
State/province [6] 0 0
Egaleo
Country [7] 0 0
Greece
State/province [7] 0 0
Kallithea, Athens
Country [8] 0 0
Greece
State/province [8] 0 0
Larissa
Country [9] 0 0
Greece
State/province [9] 0 0
Patra
Country [10] 0 0
Italy
State/province [10] 0 0
Milazzo ME
Country [11] 0 0
Italy
State/province [11] 0 0
Pisa
Country [12] 0 0
Poland
State/province [12] 0 0
Chojnice
Country [13] 0 0
Poland
State/province [13] 0 0
Gdansk
Country [14] 0 0
Poland
State/province [14] 0 0
Krakow
Country [15] 0 0
Poland
State/province [15] 0 0
Lublin
Country [16] 0 0
Poland
State/province [16] 0 0
Poznan
Country [17] 0 0
Poland
State/province [17] 0 0
Rybnik
Country [18] 0 0
Spain
State/province [18] 0 0
Andalucía
Country [19] 0 0
Spain
State/province [19] 0 0
Castilla León

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

Ethics approval
Ethics application status

Summary
Brief summary
The study will obtain data to show insight into clinical outcomes of patients switching from
Darbepoetin Alfa to a epoetin alfa biosimilar.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02191150
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02191150