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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:July 2016
End Date:May 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 or Maintenance Treatment of Anemia in Subjects With Incident Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE - CORRECTION/CONVERSION)

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction or
maintenance treatment of anemia in subjects with incident 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 correction or maintenance
treatment in subjects with anemia secondary to CKD who have recently initiated dialysis
treatment for end-stage renal disease.

Inclusion Criteria:

- ≥18 years of age

- Initiated chronic maintenance dialysis (either peritoneal or hemodialysis) for
end-stage kidney disease within 16 weeks prior to Screening

- Mean Screening hemoglobin between 8.0 and <11.0 g/dL (inclusive)

Exclusion Criteria:

- Subjects meeting the criteria of ESA resistance within 8 weeks prior to or during
Screening defined as follows

1. epoetin: > 7700 units/dose three times per week or >23,000 units per week

2. darbepoetin alfa: >100 mcg/week

3. methoxy polyethylene glycol-epoetin beta: >100 mcg every other week or >200
mcg/month

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

- Anticipated to recover adequate kidney function to no longer require dialysis

- Uncontrolled hypertension

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

- Acute coronary syndrome (hospitalization for unstable angina, 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 CHF; 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
93
sites
?
mi
from
Panorama City, CA
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
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
Astoria, NY
Click here to add this to my saved trials
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Azusa, CA
Click here to add this to my saved trials
?
mi
from
Bahia Blanca,
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Caldwell, ID
Click here to add this to my saved trials
?
mi
from
Cerritos, CA
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
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
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
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
El Cajon, 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
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
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
Grovetown, GA
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
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
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
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
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
Los Angeles, CA
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
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
Monroe, LA
Click here to add this to my saved trials
?
mi
from
Montebello, CA
Click here to add this to my saved trials
?
mi
from
Monterey Park, CA
Click here to add this to my saved trials
?
mi
from
Nampa, ID
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Newport News, VA
Click here to add this to my saved trials
?
mi
from
North Miami, FL
Click here to add this to my saved trials
?
mi
from
Northridge, CA
Click here to add this to my saved trials
?
mi
from
Norwalk, CA
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Plantation, FL
Click here to add this to my saved trials
?
mi
from
Riverside, CA
Click here to add this to my saved trials
2351 Sunset Boulevard
Rocklin, California 95765
?
mi
from
Rocklin, CA
Click here to add this to my saved trials
?
mi
from
Roseville, CA
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
San Dimas, CA
Click here to add this to my saved trials
Santa Clarita, California 91350
?
mi
from
Santa Clarita, CA
Click here to add this to my saved trials
?
mi
from
Seat Pleasant, MD
Click here to add this to my saved trials
?
mi
from
Simi Valley, CA
Click here to add this to my saved trials
?
mi
from
Stamford, CT
Click here to add this to my saved trials
?
mi
from
Statesboro, GA
Click here to add this to my saved trials
?
mi
from
Sylmar, CA
Click here to add this to my saved trials
?
mi
from
Takoma Park, MD
Click here to add this to my saved trials
?
mi
from
Tamarac, FL
Click here to add this to my saved trials
?
mi
from
Tarzana, CA
Click here to add this to my saved trials
Thomasville, North Carolina 27360
?
mi
from
Thomasville, NC
Click here to add this to my saved trials
14514 Main Street
Upper Marlboro, Maryland 20772
?
mi
from
Upper Marlboro, MD
Click here to add this to my saved trials
?
mi
from
Valencia, CA
Click here to add this to my saved trials
?
mi
from
Vidalia, GA
Click here to add this to my saved trials
?
mi
from
Warren, MI
Click here to add this to my saved trials
?
mi
from
West Covina, CA
Click here to add this to my saved trials
?
mi
from
West Sacramento, CA
Click here to add this to my saved trials
?
mi
from
Westminster, CO
Click here to add this to my saved trials
?
mi
from
Whittier, CA
Click here to add this to my saved trials