Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - 99
Updated:10/14/2018
Start Date:September 27, 2016
End Date:August 17, 2020
Contact:US GSK Clinical Trials Call Center
Email:GSKClinicalSupportHD@gsk.com
Phone:877-379-3718

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

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

The purpose of this multi-center event-driven study in non-dialysis (ND) participants with
anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of
daprodustat compared to darbepoetin alfa.


Inclusion Criteria:

- Age: 18 to 99 years of age (inclusive)

- CKD stage: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5
defined by electronic estimated glomerular filtration rate (eGFR) using the CKD
Epidemiology Collaboration (CKD-EPI) formula.

- Erythropoietin-stimulating agents (ESAs)/Hgb: Group 1 (not using ESAs): No ESA use
within the 6 weeks prior to screening and no ESA use between screening and
randomization (Day 1). Group 2 (ESA users): Use of any approved ESA for the 6 weeks
prior to screening and continuing between screening and randomization.

- For Group 1 (not using ESAs), Hgb concentration at Week -8 and Week 1 should be 8 to
10 gram per deciliter (g/dL). For Group 2 (ESA users), Hgb concentration at Week -8
should be 8 to 12 g/dL and at Week 1 should be 8 to 11 g/dL.

- >=80% and <=120% compliance with placebo during run-in period.

- Informed consent (screening only): capable of giving signed informed consent which
includes compliance with the requirements and restrictions.

Exclusion Criteria:

- Dialysis: On dialysis or clinical evidence of impending need to initiate dialysis
within 90 days after study start (Day 1).

- Kidney transplant: Planned living-related or living-unrelated kidney transplant within
52 weeks after study start (Day 1).

- Ferritin: <=100 nanograms (ng)/milliliter (mL) (<=100 micrograms/liter [L]) at
screening.

- Transferrin saturation (TSAT) (screening only): <=20%.

- Aplasias: History of bone marrow aplasia or pure red cell aplasia.

- Other causes of anemia: untreated pernicious anemia, thalassemia major, sickle cell
disease or myelodysplastic syndrome.

- Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or
esophageal ulcer disease or clinically significant GI bleeding <=4 weeks prior to
screening through to randomization (Day 1).

- MI or acute coronary syndrome: <=4 weeks prior to screening through to randomization
(Day 1).

- Stroke or transient ischemic attack: <=4 weeks prior to screening through to
randomization (Day 1).

- Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association
(NYHA) functional classification system.

- Current uncontrolled hypertension: Current uncontrolled hypertension as determined by
the investigator that would contraindicate the use of recombinant human erythropoietin
(rhEPO).

- Bazett's corrected QT interval (QTcB) (Day 1): QTcB >500 millisecond (msec), or QTcB
>530 msec in subjects with bundle branch block. There is no Q-T Interval Corrected for
Heart Rate (QTc) exclusion for subjects with a predominantly ventricular paced rhythm.

- Alanine transaminase (ALT): >2x upper limit of normal (ULN) at screening.

- Bilirubin: >1.5xULN at screening.

- Current unstable liver or biliary disease per investigator assessment, generally
defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia,
esophageal or gastric varices, persistent jaundice, or cirrhosis.

- Malignancy: History of malignancy within the 2 years prior to screening through to
randomization (Day 1) or currently receiving treatment for cancer, or complex kidney
cyst (example [e.g.] Bosniak Category II F, III or IV) > 3 centimeter (cm); with the
exception of localized squamous cell or basal cell carcinoma of the skin that has been
definitively treated >=4 weeks prior to screening.

- Severe allergic reactions: History of severe allergic or anaphylactic reactions or
hypersensitivity to excipients in the investigational product, or darbepoetin alfa.

- Drugs and supplements: Use of strong inhibitors of Cytochrome P4502C8 (CYP2C8) (e.g.,
gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin/rifampicin).

- Other study participation: Use of other investigational agent or device prior to
screening through to randomization (Day 1). At screening, this exclusion applies to
use of the investigational agent within 30 days or within five half lives (whichever
is longer).

- Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment
duration of >30 days.

- Females only: Subject is pregnant [as confirmed by a positive urine human chorionic
gonadotrophin (hCG) test for females of reproductive potential (FRP) only], subject is
breastfeeding, or subject is of reproductive potential and does not agree to follow
one of the contraceptive options.

- Other Conditions: Any other condition, clinical or laboratory abnormality, or
examination finding that the investigator considers would put the subject at
unacceptable risk, which may affect study compliance (e.g., intolerance to darbepoetin
alfa) or prevent understanding of the aims or investigational procedures or possible
consequences of the study.
We found this trial at
136
sites
Alexandria, Virginia 22304
Phone: 877-379-3718
?
mi
from
Alexandria, VA
Click here to add this to my saved trials
Akron, Ohio 44313
Phone: 877-379-3718
?
mi
from
Akron, OH
Click here to add this to my saved trials
Andalusia, Alabama 36420
Phone: 877-379-3718
?
mi
from
Andalusia, AL
Click here to add this to my saved trials
Anderson, South Carolina 29621
Phone: 877-379-3718
?
mi
from
Anderson, SC
Click here to add this to my saved trials
Atlanta, Georgia 30341
Phone: 877-379-3718
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Augusta, Georgia 30909
Phone: 877-379-3718
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Austin, Texas 78705
Phone: 877-379-3718
?
mi
from
Austin, TX
Click here to add this to my saved trials
Aventura, Florida 33180
Phone: 877-379-3718
?
mi
from
Aventura, FL
Click here to add this to my saved trials
Avondale, Arizona 85392
Phone: 877-379-3718
?
mi
from
Avondale, AZ
Click here to add this to my saved trials
Bakersfield, California 93309
Phone: 877-379-3718
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
Phone: 877-379-3718
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18105
Phone: 877-379-3718
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Birmingham, Alabama 35249
Phone: 877-379-3718
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Bluefield, West Virginia 24701
Phone: 877-379-3718
?
mi
from
Bluefield, WV
Click here to add this to my saved trials
Boca Raton, Florida 33486
Phone: 877-379-3718
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
Boston, Massachusetts 02115
Phone: 877-379-3718
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bronx, New York 10461
Phone: 877-379-3718
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Brooklyn, New York 11215
Phone: 877-379-3718
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Buffalo, New York 14263
Phone: 877-379-3718
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Canton, Ohio 44708
Phone: 877-379-3718
?
mi
from
Canton, OH
Click here to add this to my saved trials
Cerritos, California 90703
Phone: 877-379-3718
?
mi
from
Cerritos, CA
Click here to add this to my saved trials
Charleston, South Carolina 29425
Phone: 877-379-3718
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28203
Phone: 877-379-3718
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
Phone: 877-379-3718
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chicago, Illinois 60611
Phone: 877-379-3718
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chula Vista, California 91911
Phone: 877-379-3718
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Cincinnati, Ohio 45229
Phone: 877-379-3718
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Ciudad Evita, Buenos Aires
Phone: 877-379-3718
?
mi
from
Ciudad Evita,
Click here to add this to my saved trials
Columbia, South Carolina 29203
Phone: 877-379-3718
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Columbus, Georgia 31904
Phone: 877-379-3718
?
mi
from
Columbus, GA
Click here to add this to my saved trials
Coral Gables, Florida 33134
Phone: 877-379-3718
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
Coral Springs, Florida 33065
Phone: 877-379-3718
?
mi
from
Coral Springs, FL
Click here to add this to my saved trials
Cordova, Tennessee 38018
Phone: 877-379-3718
?
mi
from
Cordova, TN
Click here to add this to my saved trials
Corpus Christi, Texas 78405
Phone: 877-379-3718
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
Corsicana, Texas 75110
Phone: 877-379-3718
?
mi
from
Corsicana, TX
Click here to add this to my saved trials
Crystal Lake, Illinois 60014
Phone: 877-379-3718
?
mi
from
Crystal Lake, IL
Click here to add this to my saved trials
Cudahy, California 90201
Phone: 877-379-3718
?
mi
from
Cudahy, CA
Click here to add this to my saved trials
Cutler Bay, Florida 33189
Phone: 877-379-3718
?
mi
from
Cutler Bay, FL
Click here to add this to my saved trials
Dallas, Texas 75230
Phone: 877-379-3718
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Des Moines, Iowa 50314
Phone: 877-379-3718
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Detroit, Michigan 48202
Phone: 877-379-3718
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Doral, Florida 33172
Phone: 877-379-3718
?
mi
from
Doral, FL
Click here to add this to my saved trials
Doylestown, Pennsylvania 18901
Phone: 877-379-3718
?
mi
from
Doylestown, PA
Click here to add this to my saved trials
El Centro, California
Phone: 877-379-3718
?
mi
from
El Centro, CA
Click here to add this to my saved trials
Escondido, California 92025
Phone: 877-379-3718
?
mi
from
Escondido, CA
Click here to add this to my saved trials
Evergreen Park, Illinois 60805
Phone: 877-379-3718
?
mi
from
Evergreen Park, IL
Click here to add this to my saved trials
Fairfax, Virginia 22031
Phone: 877-379-3718
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Flushing, New York 11355
Phone: 877-379-3718
?
mi
from
Flushing, NY
Click here to add this to my saved trials
Fort Lauderdale, Florida 33308
Phone: 877-379-3718
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Wayne, Indiana 46825
Phone: 877-379-3718
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
Fountain Valley, California 92708
Phone: 877-379-3718
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Glendale, California 91204
Phone: 877-379-3718
?
mi
from
Glendale, CA
Click here to add this to my saved trials
Granada Hills, California 91344
Phone: 877-379-3718
?
mi
from
Granada Hills, CA
Click here to add this to my saved trials
Grand Forks, North Dakota 58201
Phone: 877-379-3718
?
mi
from
Grand Forks, ND
Click here to add this to my saved trials
Hampton, Virginia 23666
Phone: 877-379-3718
?
mi
from
Hampton, VA
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 877-379-3718
?
mi
from
Houston, TX
Click here to add this to my saved trials
Hudson, Florida 34667
Phone: 877-379-3718
?
mi
from
Hudson, FL
Click here to add this to my saved trials
Huntsville, Alabama 35801
Phone: 877-379-3718
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Hutchinson, Kansas 67502
Phone: 877-379-3718
?
mi
from
Hutchinson, KS
Click here to add this to my saved trials
Iowa City, Iowa 52242
Phone: 877-379-3718
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Jackson, Mississippi 39202
Phone: 877-379-3718
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Jacksonville, Florida 32207
Phone: 877-379-3718
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jeffersonville, Indiana 47130
Phone: 877-379-3718
?
mi
from
Jeffersonville, IN
Click here to add this to my saved trials
Kalamazoo, Michigan 49007
Phone: 877-379-3718
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
Knoxville, Tennessee 37916
Phone: 877-379-3718
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
La Mesa, California 91942
Phone: 877-379-3718
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
La Palma, California 90623
Phone: 877-379-3718
?
mi
from
La Palma, CA
Click here to add this to my saved trials
Lancaster, Pennsylvania 17605
Phone: 877-379-3718
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
Las Vegas, Nevada 89102
Phone: 877-379-3718
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lauderdale Lakes, Florida 33313
Phone: 877-379-3718
?
mi
from
Lauderdale Lakes, FL
Click here to add this to my saved trials
Laurelton, New York 11413
Phone: 877-379-3718
?
mi
from
Laurelton, NY
Click here to add this to my saved trials
Long Beach, California 90813
Phone: 877-379-3718
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90025
Phone: 877-379-3718
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
Phone: 877-379-3718
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Lufkin, Texas 75904
Phone: 877-379-3718
?
mi
from
Lufkin, TX
Click here to add this to my saved trials
Lynwood, California 60262
Phone: 877-379-3718
?
mi
from
Lynwood, CA
Click here to add this to my saved trials
McAllen, Texas 78503
Phone: 877-379-3718
?
mi
from
McAllen, TX
Click here to add this to my saved trials
Mentor, Ohio 44060
Phone: 877-379-3718
?
mi
from
Mentor, OH
Click here to add this to my saved trials
Meridian, Idaho 83642
Phone: 877-379-3718
?
mi
from
Meridian, ID
Click here to add this to my saved trials
Mesa, Arizona 85206
Phone: 877-379-3718
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
Metairie, Louisiana 70006
Phone: 877-379-3718
?
mi
from
Metairie, LA
Click here to add this to my saved trials
Miami, Florida 33136
Phone: 877-379-3718
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Gardens, Florida 33169
Phone: 877-379-3718
?
mi
from
Miami Gardens, FL
Click here to add this to my saved trials
Miami Lakes, Florida 33014
Phone: 877-379-3718
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
Michigan city, Indiana 46360
Phone: 877-379-3718
?
mi
from
Michigan city, IN
Click here to add this to my saved trials
Middlebury, Connecticut 06762
Phone: 877-379-3718
?
mi
from
Middlebury, CT
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
Phone: 877-379-3718
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Montebello, California 90640
Phone: 877-379-3718
?
mi
from
Montebello, CA
Click here to add this to my saved trials
Monterey Park, California 91754
Phone: 877-379-3718
?
mi
from
Monterey Park, CA
Click here to add this to my saved trials
Mount Prospect, Illinois 60056
Phone: 877-379-3718
?
mi
from
Mount Prospect, IL
Click here to add this to my saved trials
Munster, Indiana 46321
Phone: 877-379-3718
?
mi
from
Munster, IN
Click here to add this to my saved trials
Nashville, Tennessee 37203
Phone: 877-379-3718
?
mi
from
Nashville, TN
Click here to add this to my saved trials
National City, California 91950
Phone: 877-379-3718
?
mi
from
National City, CA
Click here to add this to my saved trials
New York, New York 10032
Phone: 877-379-3718
?
mi
from
New York, NY
Click here to add this to my saved trials
North Platte, Nebraska 69101
Phone: 877-379-3718
?
mi
from
North Platte, NE
Click here to add this to my saved trials
Ocala, Florida 34471
Phone: 877-379-3718
?
mi
from
Ocala, FL
Click here to add this to my saved trials
Orlando, Florida 32806
Phone: 877-379-3718
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Paramount, California 90723
Phone: 877-379-3718
?
mi
from
Paramount, CA
Click here to add this to my saved trials
Pembroke Pines, Florida 33028
Phone: 877-379-3718
?
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
Phoenix, Arizona 85012
Phone: 877-379-3718
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
Phone: 877-379-3718
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials