Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
Launched by GLAXOSMITHKLINE · Aug 22, 2016
Trial Information
Current as of May 08, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age: 18 to 99 years of age (inclusive).
- • Erythropoietin-stimulating agents (ESAs): Use of any approved ESA for at least the 6 weeks prior to screening and between screening and randomization.
- • Hgb concentration: On Week -8: Hgb 8 to 12 grams per deciliter (g/dL). On randomization (Day 1): Hgb 8 to 11 g/dL and receiving at least the minimum ESA dose. Hgb \>11 g/dL to 11.5 g/dL and receiving greater than the minimum ESA dose.
- • Dialysis: On dialysis \>90 days prior to screening and continuing on the same mode of dialysis from screening (Week -8) through to randomization (Day 1).
- • Frequency of Dialysis: Hemodialysis (HD) \>=2 times/week and peritoneal dialysis (PD) \>=5 times/week. Home hemodialysis \>=2 times/week.
- • Compliance with placebo \[randomization (Day 1) only\]: \>=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 listed in the consent form and in this protocol.
- Exclusion Criteria:
- • 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 QT 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 epoetin alfa 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).
- • Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment duration of \>30 days.
- • Females only: Subject is pregnant \[as confirmed by a positive serum human chorionic gonadotrophin (hCG) test for females of reproductive potential (FRP) only\], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow one of the contraceptive options listed in the List of Highly Effective Methods for Avoiding Pregnancy.
- • 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 rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.
About Glaxosmithkline
GlaxoSmithKline (GSK) is a global healthcare company dedicated to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong focus on research and development, GSK specializes in pharmaceuticals, vaccines, and consumer health products. The company is committed to advancing innovative therapies and preventive measures across various therapeutic areas, including respiratory, oncology, immunology, and infectious diseases. GSK's collaborative approach and rigorous clinical trial processes underscore its dedication to delivering safe and effective healthcare solutions that meet the needs of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bronx, New York, United States
Houston, Texas, United States
New York, New York, United States
Genova, Liguria, Italy
Pavia, Lombardia, Italy
Barcelona, , Spain
Madrid, , Spain
Fountain Valley, California, United States
Raleigh, North Carolina, United States
Miskolc, , Hungary
Napoli, Campania, Italy
Washington, District Of Columbia, United States
Asheville, North Carolina, United States
Mineola, New York, United States
Hampton, Virginia, United States
Leuven, , Belgium
Sacramento, California, United States
Adelaide, South Australia, Australia
Melbourne, Victoria, Australia
Singapore, , Singapore
Nashville, Tennessee, United States
Salem, Virginia, United States
La Mesa, California, United States
Baton Rouge, Louisiana, United States
Buffalo, New York, United States
Providence, Rhode Island, United States
Anaheim, California, United States
Long Beach, California, United States
San Diego, California, United States
Middlebury, Connecticut, United States
Aventura, Florida, United States
Jacksonville, Florida, United States
Ocala, Florida, United States
Jeffersonville, Indiana, United States
Greenbelt, Maryland, United States
Las Vegas, Nevada, United States
Winston Salem, North Carolina, United States
Charleston, South Carolina, United States
Córdoba, Córdova, Argentina
Kogarah, New South Wales, Australia
Westmead, New South Wales, Australia
Woolloongabba, Queensland, Australia
Hasselt, , Belgium
Varna, , Bulgaria
Milano, Lombardia, Italy
Cagliari, Sardegna, Italy
Badalona, , Spain
Sevilla, , Spain
Winter Park, Florida, United States
Cerritos, California, United States
Iowa City, Iowa, United States
Louisville, Kentucky, United States
Brooklyn, New York, United States
Edmonton, Alberta, Canada
San Luis Obispo, California, United States
Kansas City, Missouri, United States
Coral Gables, Florida, United States
Gulfport, Mississippi, United States
El Centro, California, United States
Beverly Hills, California, United States
Spring Hill, Florida, United States
Meridian, Idaho, United States
Anderson, South Carolina, United States
Chula Vista, California, United States
Alexandria, Virginia, United States
Cincinnati, Ohio, United States
Beaumont, Texas, United States
St Leonards, New South Wales, Australia
Wollongong, New South Wales, Australia
Philadelphia, Pennsylvania, United States
Buenos Aires, , Argentina
Nedlands, Western Australia, Australia
Roeselare, , Belgium
Liège, , Belgium
Mannheim, Baden Wuerttemberg, Germany
Kiel, Schleswig Holstein, Germany
Amsterdam, , Netherlands
Amadora, , Portugal
Bucharest, , Romania
Stockholm, , Sweden
Toronto, Ontario, Canada
Catanzaro, Calabria, Italy
Lisboa, , Portugal
Guadalajara, , Spain
Santiago De Compostela, , Spain
Tainan, , Taiwan
Dundee, , United Kingdom
Los Angeles, California, United States
Tarzana, California, United States
Concord, New South Wales, Australia
Tupelo, Mississippi, United States
Plovdiv, , Bulgaria
Novosibirsk, , Russian Federation
London, , United Kingdom
Columbus, Georgia, United States
Sumter, South Carolina, United States
Daejeon, , Korea, Republic Of
Girona, , Spain
Bruxelles, , Belgium
Yorba Linda, California, United States
Miami, Florida, United States
Athens, , Greece
Thessaloniki, , Greece
Sofia, , Bulgaria
Odense C, , Denmark
Yaroslavl, , Russian Federation
Arta, , Greece
Komotini, , Greece
Rostock, Mecklenburg Vorpommern, Germany
Foggia, Puglia, Italy
örebro, , Sweden
Mumbai, , India
Hamilton, , New Zealand
Gdansk, , Poland
Clayton, Victoria, Australia
Fife, , United Kingdom
London, Ontario, Canada
Praha 4, , Czechia
Praha 2, , Czechia
Glasgow, , United Kingdom
Kaiserslautern, Rheinland Pfalz, Germany
New Delhi, , India
Augusta, Georgia, United States
Trivandrum, , India
Clyde, North Carolina, United States
Poitiers, , France
Reims, , France
Piacenza, Emilia Romagna, Italy
Alcala De Henares, , Spain
Kuala Lumpur, , Malaysia
Jaipur, , India
Bordeaux, , France
Nagpur, , India
Pune, , India
Port Charlotte, Florida, United States
Kaohsiung, , Taiwan
Flushing, New York, United States
Pécs, , Hungary
Mulhouse, , France
Ioannina, , Greece
Taoyuan Hsien, , Taiwan
Veliko Tarnovo, , Bulgaria
Bakersfield, California, United States
Herston, Queensland, Australia
Alexandroupolis, , Greece
Esztergom, , Hungary
Valladolid, , Spain
Montebello, California, United States
Lecco, Lombardia, Italy
Sabadell, , Spain
Birmingham, , United Kingdom
Szigetvar, , Hungary
Cordova, Tennessee, United States
Knoxville, Tennessee, United States
Bangalore, , India
Aalborg, , Denmark
Cape Town, , South Africa
Granada Hills, California, United States
Larissa, , Greece
Lakewood, California, United States
Brussels, , Belgium
Tours Cedex 9, , France
Passo Fundo, Rio Grande Do Sul, Brazil
Pardubice, , Czechia
Caen Cedex 9, , France
Ahmedabad, , India
Riverside, California, United States
Ruse, , Bulgaria
Rotterdam, , Netherlands
Nizhniy Novgorod, , Russian Federation
Huntsville, Alabama, United States
Taipei, , Taiwan
Northridge, California, United States
Aguascalientes, , Mexico
Bergamo, Lombardia, Italy
Pazardzhik, , Bulgaria
Sao Jose Do Rio Preto, São Paulo, Brazil
Svendborg, , Denmark
Chennai, , India
Gurgaon, , India
Deventer, , Netherlands
Orenburg, , Russian Federation
Eskisehir, , Turkey
Graz, , Austria
St Petersburg, , Russian Federation
Monterey Park, California, United States
Kingswood, New South Wales, Australia
Stavanger, , Norway
Hyderabad, , India
Volzhsky, , Russian Federation
Whittier, California, United States
Bois Guillaume, , France
Ankara, , Turkey
Kayseri, , Turkey
Miami Gardens, Florida, United States
Ieper, , Belgium
Kalamazoo, Michigan, United States
Monza, Lombardia, Italy
Escondido, California, United States
Salford, , United Kingdom
Otahuhu, , New Zealand
Simi Valley, California, United States
Lufkin, Texas, United States
Pergamino, Buenos Aires, Argentina
Blagoevgrad, , Bulgaria
Gabrovo, , Bulgaria
Lovech, , Bulgaria
Johor Bahru, , Malaysia
Cuautitlan Izcalli, Estado De México, Mexico
Chihuahua, , Mexico
Ivano Frankivsk, , Ukraine
Ternopil, , Ukraine
Zhytomyr, , Ukraine
Derby, , United Kingdom
Wien, , Austria
Chernivtsi, , Ukraine
Doncaster, , United Kingdom
Ipoh, , Malaysia
Gallup, New Mexico, United States
Bethlehem, Pennsylvania, United States
Pine Bluff, Arkansas, United States
Lynwood, California, United States
Oslo, , Norway
Stevenage, Hertfordshire, United Kingdom
New Taipei, , Taiwan
St Albans, Victoria, Australia
La Palma, California, United States
Belo Horizonte, Minas Gerais, , Brazil
México, D.F., , Mexico
Gyeonggi Do, , Korea, Republic Of
Liverpool, , Australia
Dobrich, , Bulgaria
Preston, Lancashire, United Kingdom
Boulogne Billancourt, , France
Heraklion Crete, , Greece
Omsk, , Russian Federation
Hollywood, Florida, United States
Lauderdale Lakes, Florida, United States
Sokolov, , Czechia
Duesseldorf, Nordrhein Westfalen, Germany
Krasnodar, , Russian Federation
Mytischi, , Russian Federation
Hull, , United Kingdom
Oxford, , United Kingdom
Marianske Lazne, , Czechia
Keelung, , Taiwan
Palma De Mallorca, , Spain
Irkutsk, , Russian Federation
Porto Alegre, Rio Grande Do Sul, Brazil
São Paulo, , Brazil
Uppsala, , Sweden
Queretaro, Querétaro, Mexico
Anyang Si, Gyeonggi Do, , Korea, Republic Of
Seoul, , Korea, Republic Of
Daegu Si, , Korea, Republic Of
Roseville, Michigan, United States
Penza, , Russian Federation
Manises (Valencia), , Spain
Glendale, Arizona, United States
Crystal Lake, Illinois, United States
Fort Wayne, Indiana, United States
Michigan City, Indiana, United States
Takoma Park, Maryland, United States
Pontiac, Michigan, United States
Saint Louis, Missouri, United States
Ridgewood, New York, United States
Yonkers, New York, United States
Canton, Ohio, United States
Roseburg, Oregon, United States
San Antonio, Texas, United States
Fairfax, Virginia, United States
Bluefield, West Virginia, United States
Ciudad Evita, Buenos Aires, Argentina
Formosa, , Argentina
Mendoza, , Argentina
Moron, , Argentina
San Miguel De Tucumán, , Argentina
Baudour, , Belgium
Brugge, , Belgium
Salvador, Bahia, Brazil
Curitiba, Paraná, Brazil
Feira De Santana, , Brazil
Joinville, , Brazil
Sao Paulo, , Brazil
Lom, , Bulgaria
Smolyan, , Bulgaria
Beroun, , Czechia
Ivancice, , Czechia
Jilemnice, , Czechia
Holstebro, , Denmark
Kolding, , Denmark
Tallinn, , Estonia
Tartu, , Estonia
Annonay, , France
Cloppenburg, Niedersachsen, Germany
Wiesbaden, , Germany
Patras, , Greece
Calicut, , India
Chennai, Tamil Nadu, , India
Delhi, , India
Nadiad, , India
Secunderabad, , India
Torino, Piemonte, Italy
Imola, , Italy
Mestre, , Italy
Busan, , Korea, Republic Of
Goyang Si, , Korea, Republic Of
Incheon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Suwon, , Korea, Republic Of
Uijeongbu Si, , Korea, Republic Of
Wonju Si, , Korea, Republic Of
Pahang, , Malaysia
Penang, , Malaysia
Saltillo, Coahuila, Mexico
Durango., Durango, Mexico
Guadalajara, Jalisco, Mexico
Merida, Yucatán, Mexico
Ciudad De México, , Mexico
Ciudad De México, , Mexico
Zapopan, Jalisco, , Mexico
Hastings, , New Zealand
Kielce, , Poland
Kolobrzeg, , Poland
Lodz, , Poland
Covilhã, , Portugal
St. Petersburg, , Russian Federation
Cape Town., , South Africa
Majadahonda, Madrid, Spain
Ciudad Real, , Spain
Mollet Del Valles, , Spain
Adana, , Turkey
Antalya, , Turkey
Edirne, , Turkey
Chernihiv, , Ukraine
Kherson, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Mykolaiv, , Ukraine
Zaporizhzhia, , Ukraine
Wolverhampton, West Midlands, United Kingdom
Fairfield, California, United States
Hacienda Heights, California, United States
Moreno Valley, California, United States
Norco, California, United States
Ontario, California, United States
Santa Clarita, California, United States
Merrillville, Indiana, United States
Florissant, Missouri, United States
Portsmouth, New Hampshire, United States
Shorewood, Wisconsin, United States
Burzaco, Buenos Aires, Argentina
Pilar, Buenos Aires, Argentina
Birtinya, Queensland, Australia
Murdoch, , Australia
St. Pölten, , Austria
Montana, , Bulgaria
Frýdek Mistek, , Czechia
Parnu, , Estonia
Bad Koenig, Hessen, Germany
Dieburg, , Germany
Freiburg, , Germany
Minden, , Germany
Budapest, , Hungary
Egri, , Hungary
Kecskemet, , Hungary
Reggio Calabria, Calabria, Italy
Seriate, Lombardia, Italy
Bucheon Si,, , Korea, Republic Of
Goyang Si, Gyeonggi Do, , Korea, Republic Of
Batu Caves, , Malaysia
Biala Podlaska, , Poland
Grojec, , Poland
Kolo, , Poland
Olkusz, , Poland
Pruszkow, , Poland
Tomaszow Mazowiecki, , Poland
Warszawa, , Poland
Zary, , Poland
Corroios., , Portugal
Forte Da Casa, , Portugal
Mirandela, , Portugal
Portimão, , Portugal
Vila Franca De Xira, , Portugal
Vila Real (Lordelo), , Portugal
Arad, , Romania
Resita, , Romania
Targu Jiu, , Romania
Aranda De Duero, , Spain
Málaga, , Spain
New Taipei City, , Taiwan
Zhongzheng Dist., Taipei, , Taiwan
Larissa, , Greece
Sao Paulo, , Brazil
Cagliari, Sardegna, Italy
Mollet Del Valles, , Spain
Adana, , Turkey
Ankara, , Turkey
Antalya, , Turkey
Kiev, , Ukraine
Patients applied
Trial Officials
GSK Clinical Trials
Study Director
GlaxoSmithKline
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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