Medical Research Grant Request

Instructions:

All fields must be completed. If a field is not completed, please note the reason.

If it’s not applicable, please indicate N/A.

This form covers the two different ways Akebia may engage in external research:

Investigator Initiated Research: Unsolicited and independent research initiated by an external sponsor
Collaborative Research: Research conducted in collaboration between Akebia and an external sponsor

Principal Investigator Contact Information

Name

Title

Address 1

Address 2

City

State

Zip

Country

Phone

Fax

Phone

Sub-Investigator Contact Information

Name

Title

Phone

Fax

Phone

Study Coordinator Contact Information

Name

Title

Phone

Fax

Phone

Institution Contact Information

Name

Address 1

Address 2

City

State

Zip

Phone

Fax

Phone

Website

Legal/Contracts Contact Information

Name

Title

Phone

Fax

Phone

Study Information

Proposed Study Title

Indication

Primary Product

Phase

Study Population

Sample Size

Background and Study Rationale

Provide background on unanswered question(s) the study is attempting to answer

Study Objectives

List the objectives and endpoints to correspond directly with the listed Hypotheses

Hypothesis

List the Hypotheses in order of priority

Study Design/Research Plan

Provide a concise overview stating the type of experimental design

Treatment Plan

Describe the dosing regimen, administration, and schedule

Inclusion and Exclusion Criteria

Define the target population and include demographic and clinical characteristics for (in)eligibility

Laboratory Procedures/Evaluations

List all laboratory tests to be done (i.e. biochemistry, biomarkers, etc.)

Statistical Plans

Include justification for sample size and primary hypothesis testing

Direct Study Costs

Please enumerate.

Subject-Related Costs

Study-Related Personnel Costs

Diagnostic Fees

Data Management Fees

Other

Indirect Study Costs

Please enumerate.

IRB Fee

Equipment/Supply Fee

Animal-Related Costs

Other-Indirect

Total Amount

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