Efficacy and Safety Study to Evaluate Vadadustat for the Correction of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:1/10/2019
Start Date:December 2015
End Date:August 2020
Contact:Akebia Therapeutics
Email:trials@akebia.com
Phone:617-844-6128

Use our guide to learn which trials are right for you!

Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects With Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CORRECTION)

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of
anemia and maintenance of hemoglobin (Hb) in subjects with NDD-CKD

This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the
efficacy and safety of vadadustat versus darbepoetin alfa for the correction of anemia and
maintenance of Hb in subjects with NDD-CKD

Inclusion Criteria:

- ≥18 years of age

- Diagnosis of CKD with an eGFR ≤60 mL/min/1.73 m^2 at Screening and not expected to
start dialysis within 6 months of Screening

- Mean Screening hemoglobin <10.0 g/dL

Exclusion Criteria:

- Anemia due to a cause other than CKD or subjects with active bleeding or recent blood
loss

- Any erythropoietic stimulating agent within 8 weeks prior to randomization

- Uncontrolled hypertension

- Severe heart failure at Screening (New York Heart Association Class IV)

- Acute coronary syndrome (hospitalization for unstable angina or myocardial
infarction), surgical or percutaneous intervention for coronary, cerebrovascular, or
peripheral artery disease (aortic or lower extremity), surgical or percutaneous
valvular replacement or repair, sustained ventricular tachycardia, hospitalization for
HF, or stroke within 12 weeks prior to or during Screening

- Hypersensitivity to darbepoetin or vadadustat or to any of their excipients
We found this trial at
154
sites
?
mi
from
Gonzales, TX
Click here to add this to my saved trials
?
mi
from
Akron, OH
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Alexandria, VA
Click here to add this to my saved trials
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
?
mi
from
Anderson, IN
Click here to add this to my saved trials
?
mi
from
Anderson, SC
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Arlington, VA
Click here to add this to my saved trials
?
mi
from
Arvada, CO
Click here to add this to my saved trials
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Bahia Blanca,
Click here to add this to my saved trials
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
?
mi
from
Brandon, FL
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Clinton, UT
Click here to add this to my saved trials
?
mi
from
Columbia, MO
Click here to add this to my saved trials
?
mi
from
Columbia Falls, MT
Click here to add this to my saved trials
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Cooper City, FL
Click here to add this to my saved trials
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
?
mi
from
Coral Springs, FL
Click here to add this to my saved trials
?
mi
from
Covina, CA
Click here to add this to my saved trials
?
mi
from
Crystal Lake, IL
Click here to add this to my saved trials
?
mi
from
Cudahy, CA
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Danville, VA
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Denison, TX
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Desoto, TX
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Doral, FL
Click here to add this to my saved trials
East Providence, Rhode Island 02915
?
mi
from
East Providence, RI
Click here to add this to my saved trials
?
mi
from
Eatonton, GA
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
?
mi
from
Flushing, NY
Click here to add this to my saved trials
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Fountain Valley, California 92708
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
?
mi
from
Glendale, CA
Click here to add this to my saved trials
Granada Hills, California 91344
?
mi
from
Granada Hills, CA
Click here to add this to my saved trials
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Greenville, TX
Click here to add this to my saved trials
?
mi
from
Gulfport, MS
Click here to add this to my saved trials
?
mi
from
Hampton, VA
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
?
mi
from
Homestead, FL
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Jeffersonville, IN
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
?
mi
from
Laguna Hills, CA
Click here to add this to my saved trials
?
mi
from
Lake Worth, FL
Click here to add this to my saved trials
Lansdowne Town Center, Virginia 20176
?
mi
from
Lansdowne Town Center, VA
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lauderdale Lakes, Florida 33313
?
mi
from
Lauderdale Lakes, FL
Click here to add this to my saved trials
?
mi
from
Lawrenceville, GA
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Lynwood, CA
Click here to add this to my saved trials
?
mi
from
Macon, GA
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Margate, FL
Click here to add this to my saved trials
?
mi
from
Marion, OH
Click here to add this to my saved trials
?
mi
from
Maumee, OH
Click here to add this to my saved trials
?
mi
from
McAllen, TX
Click here to add this to my saved trials
?
mi
from
McKinney, TX
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Merrillville, IN
Click here to add this to my saved trials
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
?
mi
from
Methuen, MA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
?
mi
from
Miami Springs, FL
Click here to add this to my saved trials
?
mi
from
Michigan City, IN
Click here to add this to my saved trials
?
mi
from
Monroe, LA
Click here to add this to my saved trials
Morehead City, North Carolina 28557
?
mi
from
Morehead City, NC
Click here to add this to my saved trials
?
mi
from
Moses Lake, WA
Click here to add this to my saved trials
?
mi
from
Muscle Shoals, AL
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New Bern, NC
Click here to add this to my saved trials
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
New Orleans, LA
Click here to add this to my saved trials