Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - 99
Updated:9/30/2018
Start Date:May 11, 2017
End Date:June 5, 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 52-week Open-label (Sponsor-blind), Randomized, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Efficacy and Safety of Daprodustat Compared to Recombinant Human Erythropoietin in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Initiating Dialysis

The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat
in subjects with anemia associated with CKD.


Inclusion Criteria:

- 18 to 99 years of age inclusive.

- Planning to start chronic dialysis within the next 6 weeks (from the date of the
screening visit) OR have started and received dialysis (as specified below) for
end-stage renal disease for a maximum of <=90 days immediately prior to randomization
and is not expected to stop dialysis during the duration of the trial: HD >=2 times
per week or PD >=4 times per week including incremental schedule; subjects on
continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis
(APD) are eligible.

- Hemoglobin concentration as measured by HemoCue (range inclusive): 8 to 10.5 g/dL
(5-6.5 millimoles per liter [mmol/L]) at screening and 8-11.0 g/dL (5 to 6.8 mmol/L)
at randomization.

- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the consent form and in this protocol.

Exclusion Criteria:

- Planned living-related or living-unrelated kidney transplant during the study.

- Ferritin: <=100 nanograms per milliliter (ng/mL) (<=100 micrograms per liter [mcg/L])
at screening or after IV iron supplementation.

- Transferrin saturation (TSAT): <=20% at screening or after IV iron supplementation.

- Vitamin B12 (cobalamin): Below the lower limit of the reference range at screening or
after vitamin B12 supplementation.

- Folate: <2.0 ng/mL (<4.5 nanomoles per liter [nmol/L]) at screening.

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

- 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 <=10 weeks prior to
screening through to randomization (Day 1).

- Use of any Erythropoiesis-stimulating agent (ESA) treatment within 8 weeks prior to
screening except for limited use as part of dialysis initiation. Note : Limited use is
defined as no more than 6 weeks of short acting ESA (rhEPO or biosimilars; maximum of
20000 unit total) or long acting ESA (darbepoetin alfa [maximum of 100 mcg total] or
methoxy polyethylene glycol-epoetin beta [maximum of 125 mcg total]) received before
or after starting dialysis.

- Myocardial infarction or acute coronary syndrome: <=10 weeks prior to screening
through to randomization (Day 1).

- Stroke or transient ischemic attack: <=10 weeks prior to screening through to
randomization (Day 1).

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

- Current uncontrolled hypertension as determined by the Investigator that would
contraindicate the use of rhEPO.

- QT correction using Bazett's (QTcB) (Day 1): QTcB >500 milliseconds (msec), or QTcB
>530 msec in subjects with bundle branch block. There is no QTc exclusion for subjects
with a predominantly ventricular paced rhythm.

- Liver disease (any one of the following): 1. Alanine transaminase (ALT) >2 times upper
limit of normal (ULN) (screening only). 2. Bilirubin >1.5 times ULN (screening only)
(NOTE: Isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated
and direct bilirubin <35%). 3. Current unstable liver or biliary disease per
investigator assessment, generally defined by the presence of ascites, encephalopathy,
coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or
cirrhosis. NOTE: Stable chronic liver disease (including asymptomatic gallstones,
chronic hepatitis B or C, or Gilbert's syndrome) are acceptable if subject otherwise
meets entry criteria.

- 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 (i.e.
Bosniak Category II F, III or IV) >3 centimeter (cm). The only exception is localized
squamous cell or basal cell carcinoma of the skin that has been definitively treated
>=10 weeks prior to screening.

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

- Use of strong Cytochrome P4502C8 (CYP2C8) inhibitors (example gemfibrozil) or strong
CYP2C8 inducers (example rifampin/rifampicin).

- 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).

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

- Females only: Subject is pregnant [as confirmed by a positive serum human chorionic
gonadotropin (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 in the List of Highly Effective Methods for Avoiding
Pregnancy.

- 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 (example intolerance to rhEPO) or prevent understanding of the
aims or investigational procedures or possible consequences of the study.
We found this trial at
51
sites
Louisville, Kentucky 40202
Phone: 877-379-3718
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Anaheim, California 92807
Phone: 877-379-3718
?
mi
from
Anaheim, CA
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
Bakersfield, California 93309
Phone: 877-379-3718
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Baltimore, Maryland 21201
Phone: 877-379-3718
?
mi
from
Baltimore, MD
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
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
Chicago, Illinois 60611
Phone: 877-379-3718
?
mi
from
Chicago, IL
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
Coral Gables, Florida 33134
Phone: 877-379-3718
?
mi
from
Coral Gables, FL
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
Escondido, California 92025
Phone: 877-379-3718
?
mi
from
Escondido, CA
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
Hacienda Heights, California 91745
Phone: 877-379-3718
?
mi
from
Hacienda Heights, CA
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
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
Kansas City, Missouri 64128
Phone: 877-379-3718
?
mi
from
Kansas City, MO
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
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
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
Merrillville, Indiana 46410
Phone: 877-379-3718
?
mi
from
Merrillville, IN
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
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
Mineola, New York 11501
Phone: 877-379-3718
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Moreno Valley, California 92555
Phone: 877-379-3718
?
mi
from
Moreno Valley, 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
New Orleans, Louisiana 70112
Phone: 877-379-3718
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Riverside, California 92506
Phone: 877-379-3718
?
mi
from
Riverside, CA
Click here to add this to my saved trials
Roseburg, Oregon 97471
Phone: 877-379-3718
?
mi
from
Roseburg, OR
Click here to add this to my saved trials
Rosemead, California 91770
Phone: 877-379-3718
?
mi
from
Rosemead, CA
Click here to add this to my saved trials
Sacramento, California 95815
Phone: 877-379-3718
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Phone: 877-379-3718
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78258
Phone: 877-379-3718
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92111
Phone: 877-379-3718
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Luis Obispo, California 93405
Phone: 877-379-3718
?
mi
from
San Luis Obispo, CA
Click here to add this to my saved trials
Tarzana, California 91356
Phone: 877-379-3718
?
mi
from
Tarzana, CA
Click here to add this to my saved trials
Whittier, California 90606
Phone: 877-379-3718
?
mi
from
Whittier, CA
Click here to add this to my saved trials