Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Dialysis-dependent Chronic Kidney Disease (DD-CKD)



Status:Active, not recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:August 2016
End Date:March 2020

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 Maintenance Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE-CONVERSION)

A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance
treatment of anemia in subjects with DD-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 maintenance treatment of
anemia in subjects with DD-CKD

Inclusion Criteria:

- ≥18 years of age

- Receiving chronic maintenance dialysis (either peritoneal or hemodialysis) for
end-stage kidney disease for at least 12 weeks prior to Screening

- Currently maintained on ESA therapy, with a dose received within 6 weeks prior to or
during Screening

- Mean Screening Hgb between 8.0 and 11.0 g/dL (inclusive) in the US and between 9.0 and
12.0 g/dL (inclusive) outside of the US

Exclusion Criteria:

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

- 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 vadadustat, darbepoetin alfa, or any of their excipients
We found this trial at
170
sites
?
mi
from
Escondido, CA
Click here to add this to my saved trials
?
mi
from
Akron, OH
Click here to add this to my saved trials
300 Alamo Plaza
Alamo, Texas 78205
?
mi
from
Alamo, TX
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
224 Took Drive
Antioch, Tennessee 37013
?
mi
from
Antioch, TN
Click here to add this to my saved trials
2725 South Binion Road
Apopka, Florida 32703
?
mi
from
Apopka, FL
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Arvada, CO
Click here to add this to my saved trials
?
mi
from
Arvin, CA
Click here to add this to my saved trials
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Astoria, NY
Click here to add this to my saved trials
?
mi
from
Atlantis, FL
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Azusa, CA
Click here to add this to my saved trials
?
mi
from
Bahía 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
Bellflower, CA
Click here to add this to my saved trials
Bloomfield Hills, Michigan 48302
?
mi
from
Bloomfield Hills, MI
Click here to add this to my saved trials
?
mi
from
Bossier City, LA
Click here to add this to my saved trials
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
?
mi
from
Bradenton, 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
Cedar Point, NC
Click here to add this to my saved trials
?
mi
from
Cerritos, CA
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Chicopee, MA
Click here to add this to my saved trials
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Clinton Township, Michigan 48038
?
mi
from
Clinton Township, MI
Click here to add this to my saved trials
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Columbus, MS
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
Corpus Christi, TX
Click here to add this to my saved trials
?
mi
from
Covina, CA
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Downey, CA
Click here to add this to my saved trials
?
mi
from
Duncanville, TX
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
El Cajon, CA
Click here to add this to my saved trials
?
mi
from
El Centro, CA
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
Elk Grove, CA
Click here to add this to my saved trials
?
mi
from
Encino, CA
Click here to add this to my saved trials
?
mi
from
Española, NM
Click here to add this to my saved trials
?
mi
from
Fairfield, CA
Click here to add this to my saved trials
?
mi
from
Florissant, MO
Click here to add this to my saved trials
?
mi
from
Fort Oglethorpe, GA
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
Franklin, TN
Click here to add this to my saved trials
?
mi
from
Fresh Meadows, NY
Click here to add this to my saved trials
?
mi
from
Gainesville, VA
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
?
mi
from
Grand Prairie, TX
Click here to add this to my saved trials
?
mi
from
Great Neck, NY
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
?
mi
from
Greenville, TX
Click here to add this to my saved trials
?
mi
from
Grovetown, GA
Click here to add this to my saved trials
?
mi
from
Hampton, VA
Click here to add this to my saved trials
?
mi
from
Harper Woods, MI
Click here to add this to my saved trials
?
mi
from
Hephzibah, GA
Click here to add this to my saved trials
1265 Ridge Road
Hinckley, Ohio 44233
?
mi
from
Hinckley, OH
Click here to add this to my saved trials
?
mi
from
Hollywood, 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
Huntsville, AL
Click here to add this to my saved trials
?
mi
from
Hyattsville, MD
Click here to add this to my saved trials
?
mi
from
Indio, CA
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
Kinston, NC
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 Habra, CA
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
La Palma, CA
Click here to add this to my saved trials
?
mi
from
La Puente, CA
Click here to add this to my saved trials
?
mi
from
Lakewood, CA
Click here to add this to my saved trials
?
mi
from
Las Vegas, NM
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
Laurel, MD
Click here to add this to my saved trials
?
mi
from
Lawrenceville, GA
Click here to add this to my saved trials
Lexington, North Carolina 27292
?
mi
from
Lexington, NC
Click here to add this to my saved trials
?
mi
from
Lincoln, CA
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
1800 Main Street Northeast
Los Lunas, New Mexico 87031
?
mi
from
Los Lunas, NM
Click here to add this to my saved trials
?
mi
from
Madison, AL
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Manassas, VA
Click here to add this to my saved trials
?
mi
from
McAllen, TX
Click here to add this to my saved trials
?
mi
from
Meridian, ID
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
Metter, GA
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 Gardens, FL
Click here to add this to my saved trials
?
mi
from
Mission, TX
Click here to add this to my saved trials