Last updated on January 2020

A Phase IIA Study of Blood Pressure Comparing Daprodustat to an Erythropoiesis-stimulating Agent in Subjects With Anemia of Chronic Kidney Disease on Hemodialysis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Anemia; Non-Hodgkins Lymphoma | Anemia
  • Age: Between 40 - 100 Years
  • Gender: Male or Female

Inclusion Criteria

  • More than or equal to 40 years of age, at the time of signing the informed consent
  • Stable Hgb 8.5 to 11.5 grams per deciliter (g/dL) inclusive.
  • Dialysis frequency: On hemodialysis (HD, hemofiltration or hemodiafiltration) three-to five-times weekly for at least 4 weeks prior to screening.
  • A single pool Kt/Vurea >=1.2 based on a historical value obtained within 3 months prior to screening in order to ensure the adequacy of dialysis. If Kt/Vurea is not available, then an average of the last 2 values of urea reduction ratio should be at least 65%.
  • Treated with an ESA (epoetins or their biosimilars, darbepoetin, or methoxy polyethylene glycol [PEG]-epoetin beta) for at least 4 weeks prior to screening.
  • Subjects may be on stable maintenance oral or intravenous (IV; <=100 mg/week) iron supplementation. If subjects are on oral or IV iron, then doses must be stable for the 4 weeks prior to Washout.
  • Estimated Dry Weight: Mid-week average weight gain between dialysis treatments <5% as assessed pre- and post-dialysis from screening to Washout.
  • On at least 1 antihypertensive medication (excluding diuretics) and on that same medication and the same dose for at least 1 week prior to Washout.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and the protocol.
  • Willing and able to wear ABPM device for at least 25 hours on two separate sessions.

Exclusion Criteria

  • Planned change from HD to peritoneal dialysis within the study time period, or on home dialysis.
  • Planned for kidney transplant within the 16 weeks following the Screening visit.
  • An epoetin alfa dose of >=360 IU/kg/week IV or >=250 IU/kg/week subcutaneous (SC), or darbepoetin dose of >=1.8 micrograms (g)/kg/week IV or SC, or methoxy PEG-epoetin beta dose of >=2.2 g/kg/week within the 8 weeks prior to screening through Week -4.
  • Planned or recorded administration of Mircera (methoxy PEG-epoetin beta) within the 4 weeks prior to the Washout.
  • Occurrence of myocardial infarction or acute coronary syndrome within 3 months prior to Washout.
  • Stroke or transient ischemic attack within 3 months prior to Washout.
  • Chronic Class IV heart failure, as defined by the New York Heart Association functional classification system diagnosed prior to Washout.
  • QT interval corrected for heart rate using Bazett's formula (QTcB) >500 milliseconds (msec), or QTcB >530 msec in subjects with Bundle Branch Block. There is no QTc exclusion for subjects with a predominantly paced rhythm.
  • Resting SBP >160 millimeter of mercury (mmHg); or DBP >100 mmHg at screening.
  • Presence of atrial fibrillation.
  • Active chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosus, rheumatoid arthritis, celiac disease) diagnosed prior to Washout.
  • History of bone marrow aplasia or pure red cell aplasia.
  • Other causes of anemia including Pernicious anemia, thalassemia major, sickle cell disease or myelodysplastic syndrome.
  • Alanine transaminase (ALT) >2 times upper limit of normal (ULN) (screening only) or Bilirubin >1.5 times ULN (screening only) or 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.
  • Major surgery (excluding vascular access surgery) within the 3 months prior to Washout, or planned during the study.
  • Blood transfusion within the 8 weeks prior to Washout, or an anticipated need for blood transfusion during the study.
  • Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease OR clinically significant gastrointestinal bleeding within the 8 weeks prior to Washout.
  • Clinical evidence of acute infection or history of infection requiring IV antibiotic therapy within the 8 weeks prior to Washout.
  • History of malignancy within the two years prior to screening through Day 1 or currently receiving treatment for cancer, or has a known complex kidney cyst (e.g., Bosniak Category IIF, III or IV) >=3 centimeters.
  • Subjects with an upper arm diameter which cannot be measured by oscillometer/ sphygmomanometer cuff OR for whom BP cannot be measured in the opposite arm of current vascular access.
  • History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.
  • Use of any prescription or non-prescription drugs or dietary supplements that are prohibited from screening until Washout.
  • The subject has participated in a clinical trial and has received an experimental investigational product within the 30 days prior to Day 1 or within 5 half lives of the investigational product prior to screening, whichever is longer.
  • 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.
  • A female subject is pregnant (as confirmed by a positive serum human chorionic gonadotrophin test for females of reproductive potential only), subject is breastfeeding, or subject is of reproductive potential and does not agree to follow one of the pre-specified contraceptive options
  • Vitamin B12 at or below the lower limit of the reference range (may rescreen in a minimum of 8 weeks, following treatment).
  • Folate at <2.0 nanograms (ng)/milliliter (mL) (4.5 Nanomoles/L) (may rescreen in a minimum of 4 weeks, following treatment).
  • Ferritin at <100 ng/mL
  • Transferrin saturation at <20%.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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