CLINICAL TRIALS MEAN ACCESS TO CUTTING EDGE TREATMENT.

Anemia of CKD

A Clinical Research study performed in conjunction with Volunteer Medical Research and Coastal Nephrology Associates of Port Charlotte, FL.

Study Overview

Study Title

A phase 3 randomized, open-label (sponsor-blind), active-controlled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa

Protocol No: 200808

Sponsor: GlaxoSmithKline

Investigator: Kianoosh Kaveh, DO

Introduction

You have been asked to take part in a clinical trial, a type of research study, which we shall refer to as a “study”. This consent form has been reviewed by Quorum Review, an Independent Review Board (IRB). This board reviews research studies to protect the rights and well-being of the people taking part.

Purpose of this Study

You have been asked to participate in this research study of an investigational drug called daprodustat because your kidney doctor has determined that you have anemia associated with chronic kidney disease.

The purpose of this study is to test how effective daprodustat (an investigational drug which has not been approved in the United States by the U.S. Food and Drug Administration [FDA]) is compared with darbepoetin alfa (a drug which has been approved by the FDA to treat anemia associated with chronic kidney disease) for anemia and to see how safely this dosing can be done over a long period of time. Be aware that this form refers to daprodustat and darbepoetin alfa as “study drug.”

Costs of Participation
Procedures, study drug and tests that are done only as part of this research study will be provided to you free of charge.

Compensation
You will get paid for your participation in this study according to the schedule in the Informed Consent Form. Download it using the button below. Payment ranges from $50-$150 per visit.

INFORMED CONSENT FORM (FULL)

Please fill out all required fields.

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Questions or concerns?

Your answers on the questionnaire are not set in stone. If you are unsure about an entry, simply make a note in the Additional Questions or Concerns field at the bottom of the form.