Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:10/14/2018
Start Date:March 5, 2018
End Date:November 5, 2020
Contact:US GSK Clinical Trials Call Center
Email:GSKClinicalSupportHD@gsk.com
Phone:877-379-3718

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A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naïve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo

The purpose of this multi-center study in non-dialysis subjects with anemia associated with
CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.


Inclusion Criteria:

- >=18 years of age at the time of signing the informed consent.

- Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI)
CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the
CKD Epidemiology Collaboration (CKD-EPI) formula.

- Subjects with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and
from 8.5 to 10.0 g/dL at randomization (Day 1).

- Subjects may receive up to one intravenous (IV) iron dose within the 8 weeks prior to
screening and NO IV iron use between screening visit and randomization (Day 1).

- If needed, subject may be on stable maintenance oral iron supplementation. The type of
iron and dose must not be changed for the 4 weeks prior to screening (Week -4),
through the screening period, and until randomization (Day 1).

- Male and female subjects are eligible. A female subject is eligible to participate if
she is not pregnant, not breastfeeding, and at least one of the following conditions
applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow
the contraceptive guidance during the treatment period and for at least 4 weeks after
the last dose of study treatment.

- Capable of giving signed informed consent.

Exclusion Criteria:

- Subjects who are on dialysis or clinical evidence of impending need to initiate
dialysis within 180 days after randomization (Day 1).

- Planned living-related or living-unrelated kidney transplant within 28 weeks after
randomization (Day 1).

- Transferrin saturation (TSAT) <15 percent (Screening only).

- Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).

- History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO
use between screening and randomization (Day 1).

- History of transfusion within the 8 weeks prior to screening and transfusion between
screening and randomization (Day 1).

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

- Subjects with Megaloblastic anemia (untreated pernicious anemia and folate
deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.

- Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or
clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening
through to randomization (Day 1).

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

- Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of
CYP2C8 (for example, rifampin/rifampicin).

- Ferric citrate use within 4 weeks prior to randomization (Day 1).

- Use of another investigational agent within 30 days or within five half-lives of the
investigational agent (whichever is longer) or currently participating in a study of
an investigational device prior to screening through to randomization (Day 1).

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

- MI or acute coronary syndrome within the 8 weeks prior to screening through to
randomization. (Day 1).

- Stroke or transient ischemic attack within the 8 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.

- QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530
msec in subjects with bundle branch block. There is no corrected QT interval (QTc)
exclusion for subjects with a predominantly paced rhythm.

- Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).

- Bilirubin >1.5xULN at screening (Week -4).

- 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.

- 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 (for
example, Bosniak Category II F, III or IV) > 3 centimeters (cm).

- 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 or prevent understanding of the aims or investigational
procedures or possible consequences of the study.
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