INVESTIGATOR INITIATED RESEARCH (IIR)
GRANT APPLICATION FORM – Renal PD APAC
Submit to: Global Grant Program Manager (GPM) at baxter_science@baxter.com
*ONLY GRANT APPLICATIONS ALIGNED TO SPECIFIC RESEARCH OBJECTIVES OUTLINED BELOW ARE
ELIGIBLE FOR FUNDING:
All Asia- Pac
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Exploring the impact of optimal (team) standardized care and guideline adherence,
or Quality improvement initiatives on PD patient outcomes (hospitalization, clinical,
HRQoL and patient-centered) and/or health economic outcomes in peritoneal
dialysis therapy. Specific areas of interest include initiatives around:
 PD catheter insertion
 prevention of peritonitis and exit site infection
 improving care and access to care in developing or rural communities
Exploring sustainable solutions for PD clinical quality improvement through
database/registry linkage
Exploring the effect of APD on patient outcomes (hospitalization, clinical, HRQoL
and patient-centered)
Exploring the effect of low, regular, and high calcium dialysate on mineral
metabolism, CVD, and metabolic bone disease.
Exploring the impact of PD catheter insertion programs and/or catheter education
programs on:
 success of urgent start PD, and/or
 early (i.e. first 90 day) technique outcome (catheter function and survival),
and/or
 early (i.e. first 90 day) complications (peritonitis, exit site infection), and/or
 incident modality selection
Economic evaluation (cost-effectiveness, cost utility) of PD versus in-centre HD
from a societal or payer (rather than provider) perspective, especially but not
necessarily exclusively in developing and rural populations
Exploring the effect of enhanced standardized low-clearance / predialysis care on
patient outcomes (hospitalization, clinical, HRQoL and patient-centered) and
incident modality selection
Exploring the effect of PD versus HD for patient-centered PD outcomes (HRQoL,
employment status, patient-centered such as the ability to enjoy leisure activities)
Exploring the effect of shared decision-making around modality choice on patientcentered PD outcomes (HRQoL, patient satisfaction, adherence to care)
Exploring the effect of low glucose PD therapy (using Extraneal and/or Nutrineal)
on outcomes in PD patients, including
 biochemistry / metabolism (e.g. hyperglycemia in diabetic patients without
fluid overload, body composition, MIA), and/or
 cardiovascular disease and events (e.g. extracellular volume in patients
with fluid overload), and/or
 infectious complications and events
 peritoneal membrane structure and function, and/or
 hospitalization, and/or
 HRQoL and patient-centered outcomes, and/or
 economic outcomes that might accrue
Assessing the impact of remote monitoring on clinical and economic outcomes in
PD populations. More specifically, clinical parameters of interest include the
following: patient adherence, blood pressure control, volume management,
dropout/technique failure (particularly for high risk patients), ED visits,
hospitalization, and facility-clinic workflow/resource utilization
INVESTIGATOR INITIATED RESEARCH (IIR)
GRANT APPLICATION FORM – Renal PD APAC
baxter_science@baxter.com
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Exploring the effect of health service delivery through PD satellite centers on
outcomes in PD patients (hospitalization, clinical, HRQoL and patient-centred)
and/or incident patient modality selection
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Exploring unmet need for (untreated) ESRD and/or estimating of the attributable
benefit (life years saved) of greater access to dialysis
Exploring the effect of enhanced health care delivery models (PD counselling
center, enhanced low-clearance clinic care, PD Start Nurse) on outcomes in PD
patients and/or incident modality selection
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Additional Country
Specific Objectives
China
India
Japan
Assessing the impact of availability of APD technology and remote monitoring on
incident patient modality selection
Assessing the clinical-economic impact of urgent start PD programs
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Exploring the effect of assisted PD for improving outcomes (hospitalization, clinical,
HRQoL and patient-centred) and/or incident modality selection
Clinical studies to evaluate the efficacy of Reguneal, with particular view on
improved biocompatibility, peritoneal membrane preservation, and acid-base
balance
Clinical studies to evaluate the efficacy of Tsunagu
Exploring the effect of PD versus HD chosen for “medical” indications on outcomes
of Japanese patients (hospitalization, clinical, HRQoL and patient-centred). This
would involve analyses in well-defined patient subgroup e.g. incident patients with
residual renal function, young healthy patients, elderly co-morbid patients
Exploring the effect of PD+HD combination therapy on preservation of peritoneal
membrane and/or improved fluid volume/solute clearance for Japanese patients
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Exploring unmet needs and burden of disease around urgent starts on dialysis and
assessing the clinical and economic benefits of greater access to urgent start PD
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Exploring the barriers to “Home First / Preferred” or “PD First / Preferred” policies
and practice patterns
Exploring the effect of “Home First / Preferred” or “PD First / Preferred” policies and
practice patterns on patient outcomes (hospitalization, clinical, HRQoL and patientcentered), and/or incident modality selection
Exploring the effect of “Home First / Preferred” or “PD First / Preferred” policies and
practice patterns on economic outcomes from a societal (rather than provider or
professional) perspective
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Exploring the effect of the PD First policy on the previous unmet need around
untreated ESKD, in terms of population outcomes (life years saved)
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Impact of health care delivery models (PD counselling centre, enhanced lowclearance clinic care, PD Start Nurse) in Singapore on outcomes of PD patients
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INVESTIGATOR INITIATED RESEARCH (IIR)
GRANT APPLICATION FORM – Renal PD APAC
baxter_science@baxter.com
Korea
and/or incident modality selection
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Exploring the effect of health service delivery through PD satellite centers on
outcomes in PD patients (hospitalization, clinical, HRQoL and patient-centred)
and/or incident patient modality selection
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Exploring the effect of enhanced nursing models of care (ratio, experience, nurse
education training programs) on outcomes in PD patients (hospitalization, clinical,
HRQoL and patient-centered)
Australia/New
Zealand
Thailand
Singapore
Vietnam
Malaysia
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INVESTIGATOR INITIATED RESEARCH (IIR)
GRANT APPLICATION FORM – Renal PD APAC
baxter_science@baxter.com
CLINICAL EVIDENCE COUNCIL (CEC) FOR RENAL PERITONEAL DIALYSIS (PD)
INSTRUCTIONS & SUBMISSION PROCESS:
 The IIR Grant Application Form must be completed ONLY by the Investigator submitting the Grant
Application. No Baxter personnel may assist in the preparation of the form.
 The IIR Grant Application Form must be completed in English, typed, single-spaced, font size 10
 Complete all fields providing as much information as necessary to clarify the study. All fields are expandable.
For any fields not applicable to the specific study, mark ‘N/A’.
 E-mail the completed IIR Grant Application Form to: baxter_science@baxter.com
 Attach the CV of the principal investigator to the grant application email
 IIR Grant Application Forms MUST be sent to baxter_science@baxter.com by the published submission
deadline
There are two opportunities for submission of grant round proposal(s).
Investigator submits to Baxter Medical Affairs team member or to
science_SP@baxter.com by:
Round I
April 24, 2015
Round II
August 25, 2015
FUNDING:
 Up to $50,000 USD per year for up to 3 years
NOTE: Incomplete applications will render your request ineligible to be considered for the current funding
cycle.
Questions: Contact the Grant Program Manager at baxter_science@baxter.com
Baxter’s acceptance of a proposal and request for funding is not an indication that Baxter will fund research. By
submitting materials to Baxter for review, you, the investigator, acknowledge that Baxter will not treat the information
as confidential or proprietary and that Baxter has no obligation to keep the information confidential.
Please do not consider any request approved without written documentation of approval of the application from
Baxter. Any award is contingent on availability of funds and subject to terms and conditions required by Baxter, and
will be included in a grant agreement.
Actual receipt of funding is contingent upon timely execution of a grant agreement by both parties. Approval of a
grant alone is not sufficient for disbursement of funds.
Submission of one or more grant application(s) is deemed to be acceptance of these provisions.
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INVESTIGATOR INITIATED RESEARCH (IIR)
GRANT APPLICATION FORM – Renal PD APAC
baxter_science@baxter.com
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Complete the grant application form for funding of an Investigator Initiated Research (IIR) study
Complete all fields providing as much information as necessary to clarify the study. All fields are expandable.
For any fields not applicable to your study, mark ‘N/A’.
Submit the grant application form with the CV of the principal investigator
In order to be eligible all requests must be received by Baxter Healthcare Corporation in accordance with the
submission instructions and published submission deadlines
NOTE: Incomplete applications may render your request ineligible for the current funding cycle.
THIS FORM MUST BE COMPLETED BY THE INVESTIGATOR SUBMITTING THE GRANT APPLICATION
•
COMPLETE ALL FIELDS PROVIDING AS MUCH INFORMATION AS NECESSARY TO CLARIFY THE STUDY
•
IF A FIELD IS NOT APPLICABLE TO YOUR STUDY, MARK ‘N/A’; ALL FIELDS ARE EXPANDABLE
CENTER/ INSTITUTION CONTACT INFORMATION
Date:
Principal Investigator
Grant Number: Baxter use only
Co-Investigator*
Study Coordinator
Name (First, Last)
Title
Institution
Address/Department
City/State/Prov.
Postal Code/Country
Telephone
Fax
Email
Signature
Sponsor (Head of the department of the institution submitting the grant application, who on behalf of the department, commits to provide the
necessary resources to ensure execution of the research and fulfillment of the legal responsibilities as sponsor)
Name:
Have you previously applied for a Baxter grant?
Yes
No
If “Yes”, when?
Email:
Was the study funded?
Study Title:
Signature:
Yes
No
*There may be more than one Investigator if appropriate.
RESEARCH STUDY
Study Conduct
Location(s):
Number of Sites:
Facility / Institution Name
Is all research to be performed outside of the United States?
Yes
No
Country
Signature:
Title:
Date:
Study Title:
Research Question:
Study Background & Rationale: (background information including previous studies as applicable )
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INVESTIGATOR INITIATED RESEARCH (IIR)
GRANT APPLICATION FORM – Renal PD APAC
baxter_science@baxter.com
Primary Endpoint: (align with the research question stated above; on which the power calculation is based)
Secondary Endpoints:
Study Design
Study Type: (select one)
Clinical Interventional
Clinical Non-Interventional
Non-clinical (i.e., benchwork, in-vitro, animal model)
Other (explain):
Does the proposed research require an Investigational New Drug (IND)/Investigational Device Exemption (IDE)
application (US), a Clinical Trial Application (CTA) (Canada and EU), and/or any other similar regulatory filing?
Yes
No Explain the basis for your determination:
Pathology, disease state, or condition to be treated/studied and incidence:
Study Population (ages, gender, relevant disease states):
Key Inclusion Criteria:
Key Exclusion Criteria:
Duration of subject participation:
Total number of subjects to be enrolled:
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Number of study or comparison groups:
Specific details of Treatment/Intervention: (prescription and/or therapy, devices, equipment, solutions, product
to be used in conducting study:
Efficacy Assessments (What data will be collected/utilized?):
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INVESTIGATOR INITIATED RESEARCH (IIR)
GRANT APPLICATION FORM – Renal PD APAC
baxter_science@baxter.com
Statistical Methods (for analyzing primary & secondary endpoints):
Is the study sufficiently powered (adequate sample size) to answer the research question? Explain:
Is Baxter product support requested (drugs and biologics, or devices)?
Yes
No
If YES - Provide details
Drugs and Biologics:
Baxter Product(s):
Product Name/Code
Dose Range
Dosing Schedule
Duration of Treatment
Drug Amount Requested
Route of Administration
Reference Product(s)/
Comparator(s):
Dose Range
Dosing Schedule
Duration of Treatment
Drug/Device Amount
Requested
Route of Administration
Devices:
Baxter Product(s):
Product Name/Code
Amount Requested
Describe how devices will be used in the study:
Time Estimates/Dates - If not applicable, mark ‘N/A’
Study Start/End Date:
Start:
End:
Study Duration (either
FirstSubjectFirstVisit:
Other:
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Not Applicable
INVESTIGATOR INITIATED RESEARCH (IIR)
GRANT APPLICATION FORM – Renal PD APAC
baxter_science@baxter.com
FSFV/LSLV, or applicable):
Will you seek IRB or
Ethics Board Approval?
LastSubjectLastVisit:
Yes
Anticipated approval date:
No (explain):
Are other internal reviews
required by your
institution?
Yes (identify):
Anticipated approval date:
No
Will informed consent be
obtained?
Yes (describe process to obtain):
No (explain):
Adverse Event Reporting (for clinical research including interventional and non-interventional studies)
If awarded, Baxter will specifically describe the Adverse Event Reporting requirements set forth below in the Grant
Agreement, which will include a requirement that the adverse event reporting and notification principles are clearly
reflected and described in the protocol; therefore, the Investigator is expected to have the appropriate systems,
resources and training to meet the requirements for Adverse Event Reporting.
1. Investigator is responsible for reporting AEs to IRB, participating investigators and applicable regulatory
authorities as required per regulations with an expedited copy sent simultaneously to Baxter; and
2. If Baxter product is used in Study, all SAEs/significant safety concerns must be sent to Baxter within 24 hours
[include non-serious AEs for non-interventional studies if they are collected per protocol].
Describe the method and plan for meeting the reporting requirements:
Publication Plan (describe the proposed publication plan with dates including abstract(s) to congresses and
journal publications for this study):
CENTER / INSTITUTION BUDGET INFORMATION
Provide full justification for all budget items relative to the proposed research. The budget requested must accurately reflect the actual funds required
to execute the proposed research. Permitted expenses include a contribution towards the salary of the principal investigator, co-investigators, and
support staff, e.g. coordinator or data manager, statistician, plus equipment and supplies specifically required to complete the study’s aim. Travel
expenses directly related to the implementation of the study are allowed plus those required disseminating the results at scientific congresses. In
addition, the costs associated with the publication of the research are permitted. Costs associated with applying for an IND or its equivalent and with
IRB/ethics board review are also allowed. If requested and approved, Baxter will provide product. Institutional Overhead Payments (IOP) may be
requested and should be included in the amount requested. IOP will be paid out of the amount funded, not in addition to it.
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Budget may be for one or multiple years depending upon the requirements of the study
Identify all expenses that make up the Total Study Budget, even if only a portion of the funding is being
requested from Baxter
Personnel – (i.e., percentage of time)
State roles and explain why you require the
level (in terms of qualifications & salary) that
you are requesting.
Investigator:
Research Assistants:
Other personnel (please specify):
Year 1
(US$)
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Year 2
(US$)
Year 3
(US$)
Total
(US$)
INVESTIGATOR INITIATED RESEARCH (IIR)
GRANT APPLICATION FORM – Renal PD APAC
baxter_science@baxter.com
Total personnel expenditure:
Detail & Rationale:
Materials, Supplies & Services - Expendable
Itemize the expendables and services; for
example, number and cost of animals, nature
and amounts of reagents, number of
subjects, etc.
Animals:
Laboratory Supplies (expendables):
Services:
Other (please specify):
Year 1
(US$)
Year 2
(US$)
Year 3
(US$)
Total
(US$)
Year 3
(US$)
Total
(US$)
Total expendable expenditure:
Detail & Rationale:
Leasing of Equipment and/or Maintenance Items – Non-expendable
Indicate – a) anticipated extent of use; b)
Year 1
Year 2
availability of similar equipment; c) reason for
(US$)
(US$)
choice in relation to alternatives; d) as
applicable, necessity for upgrade of existing
equipment or service contract. Any
equipment should be leased and returned at
end of study.
Equipment (non-expendable):
Maintenance (non-expendable):
Total non-expendable expenditure:
Detail & Rationale:
Other Related Expenses – IRB/REB/IACUC Review, Travel, Publications, Database Leasing, etc. (please detail):
Indicate all expenses and fees anticipated for
Year 1
Year 2
Year 3
Total
the study.
(US$)
(US$)
(US$)
(US$)
Ethics Review Fees (please specify):
Travel (please specify):
Publication(s), e.g. poster design/printing,
manuscript writing/editing (please specify):
Database Leasing (please specify):
Other Expenses (please specify-add rows as
needed):
Total other expenditure:
Detail & Rationale:
Additional Budget Detail & Rationale (provide any additional detail)
Budget & Funding Summary
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INVESTIGATOR INITIATED RESEARCH (IIR)
GRANT APPLICATION FORM – Renal PD APAC
baxter_science@baxter.com
Year 1
(US$)
Year 2
(US$)
Year 3
(US$)
Total
(US$)
Total Study Budget in US Dollars:
Funding
Funding support requested from Baxter
(excluding Baxter Product and Institutional
Overhead Expense):
Institutional Overhead Expense (IOE) may be
requested and should be included in the
Budget & Funding Summary. IOE may not to
exceed 20% of funding support requested
from Baxter. IOE will be paid out of the
amount funded, not in addition to it:
Total funding support requested from
Baxter (sum of above two lines):
Total other 3rd Party funding support.
Describe any concurrent funding including
current grants, pending grant applications
and any planned grant applications. Include a
statement regarding potential overlap of the
concurrent funding with the present
application. Specify source(s) and dollar
amount(s).
Total of all Funding (should equal Total
Study Budget + Institutional Overhead
Expense):
Submission Checklist: Only complete applications will be reviewed. All fields on the application
are required. If not applicable, list N/A.
Completed and signed Investigator Initiated Research (IIR) Grant Application Form
Curriculum Vitae of principal investigator
You may also attach additional supporting documents (optional; please check box if applicable)
Application Submission: Send your complete grant application form and required attachment(s) via email
(preferred), courier, or fax by the published submission deadline:
There are two separate grant round opportunities for submission of proposal(s).
Round I
Investigator submits to Baxter Medical Affairs team member or to
April 24, 2015
science_SP@baxter.com by:
Mailing address:
Baxter Healthcare Corporation
Attn: Kelly Machak
25212 W. IL Route 120, RLT-10
Round Lake, Illinois 60073
Email: baxter_science@baxter.com
For additional information contact the GPM at: baxter_science@baxter.com
Page 10
Round II
August 25, 2015