Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

Phase 3, Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)

Sponsors

Lead Sponsor: Akebia Therapeutics

Source Akebia Therapeutics
Brief Summary

A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in subjects with NDD-CKD

Detailed Description

This is a multicenter, randomized, open-label, active-controlled Phase 3 study of the efficacy and safety of vadadustat versus darbepoetin alfa for the maintenance treatment of anemia in subjects with NDD-CKD

Overall Status Active, not recruiting
Start Date February 2016
Completion Date August 2020
Primary Completion Date June 5, 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean change in Hb between baseline and the primary evaluation period Baseline visit, Week 36
Major adverse cardiovascular events (MACE), defined as all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke From Baseline visit to end of study (event-driven, minimum 1 year)
Secondary Outcome
Measure Time Frame
Mean change in Hb value between Baseline and the secondary evaluation period Baseline visit, Week 52
Proportion of subjects with Hb values within the target range during the primary evaluation period Baseline visit, Week 36
Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline visit to end of study (event-driven, minimum 1 year)
Proportion of time with Hb values within the target range during the primary evaluation period Baseline visit, Week 36
Proportion of time with Hb values within the target range during the secondary evaluation period Baseline visit, Week 52
Proportion of subjects with Hb values within the target range during the secondary evaluation period Baseline visit, Week 52
Proportion of subjects with Hb increase of >1.0 g/dL from Baseline visit From baseline visit to end of study (event-driven, minimum 36 weeks)
Time to achieve Hb increase of 1.0 g/dL from Baseline visit From baseline visit to end of study (event-driven, minimum 36 weeks)
Mean change in Hb between Baseline (mean pretreatment Hb) and the primary evaluation period (mean Hgb from weeks 24-36) stratified b pre-baseline ESA exposure Baseline visit, Week 36
Proportion of subjects receiving IV iron therapy Baseline visit, Week 52
Mean monthly dose of IV elemental iron administered in subjects who have received IV iron Baseline visit, Week 52
Proportion of subjects receiving RBC transfusion(s) Baseline visit, Week 52
Enrollment 1752
Condition
Intervention

Intervention Type: Drug

Intervention Name: vadadustat

Description: oral tablet

Arm Group Label: vadadustat

Other Name: AKB-6548

Intervention Type: Drug

Intervention Name: darbepoetin alfa

Description: Subcutaneous

Arm Group Label: darbepoetin alfa

Other Name: aranesp

Eligibility

Criteria:

Inclusion Criteria:

- ≥18 years of age

- Diagnosis of CKD with an eGFR ≤60 mL/min/1.73 m^2 at Screening and not expected to start dialysis within 6 months of Screening

- Currently maintained on ESA therapy, with a dose received within 6 weeks prior to or during Screening

- Mean Screening HGB between 8.0 and 11.0 g/dL (inclusive) in the US and between 9.0 and 12.0 g/dL (inclusive) outside of the US

Exclusion Criteria:

- Uncontrolled hypertension

- Severe heart failure at Screening (New York Heart Association Class IV)

- Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular, or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for HF, or stroke within 12 weeks prior to or during Screening

- Hypersensitivity to darbepoetin or vadadustat or to any of their excipients

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Akebia Therapeutics Study Director Sponsor GmbH
Location
Facility:
Research Site | Birmingham, Alabama, 35211, United States
Research Site | Huntsville, Alabama, 35805, United States
Research Site | Tuscumbia, Alabama, 35674, United States
Research Site | Glendale, Arizona, 85306, United States
Research Site | Mesa, Arizona, 85210, United States
Research Site | Phoenix, Arizona, 85027, United States
Research Site | Tucson, Arizona, 85718, United States
Research Site | Tucson, Arizona, 85724, United States
Research Site | Anaheim, California, 92801, United States
Research Site | Bakersfield, California, 93309, United States
Research Site #1 | Chula Vista, California, 91910, United States
Research Site #2 | Chula Vista, California, 91910, United States
Research Site | El Centro, California, 92243, United States
Research Site | Fountain Valley, California, 92708, United States
Research Site | Glendale, California, 91206, United States
Research Site | Granada Hills, California, 91344, United States
Research Site | La Mesa, California, 91942, United States
Research Site | Laguna Hills, California, 92653, United States
Research Site | Long Beach, California, 90807, United States
Research Site | Long Beach, California, 92886, United States
Research Site | Los Angeles, California, 90048, United States
Research Site | Lynwood, California, 90260, United States
Research Site #1 | Northridge, California, 91324, United States
Research Site #2 | Northridge, California, 91324, United States
Research Site | Riverside, California, 92505, United States
Research Site | Roseville, California, 95661, United States
Research Site | Salinas, California, 93901, United States
Research Site | San Diego, California, 92103-6204, United States
Research Site #1 | San Dimas, California, 91773, United States
Research Site #2 | San Dimas, California, 91773, United States
Research Site | Santa Ana, California, 92704, United States
Research Site | Santa Monica, California, 90404, United States
Research Site | Sherman Oaks, California, 91403, United States
Research Site | Thousand Oaks, California, 91360, United States
Research Site | Whittier, California, 90603, United States
Research Site | Whittier, California, 99999, United States
Research Site | Arvada, Colorado, 80002, United States
Research Site | Denver, Colorado, 80230, United States
Research Site | Westminster, Colorado, 80031, United States
Research Site | Stamford, Connecticut, 06902, United States
Research Site | Waterbury, Connecticut, 06708, United States
Research Site | Bradenton, Florida, 34209, United States
Research Site | Brandon, Florida, 33511, United States
Research Site | Cooper City, Florida, 33024, United States
Research Site #1 | Coral Gables, Florida, 33134, United States
Research Site #2 | Coral Gables, Florida, 33134, United States
Research Site | Coral Springs, Florida, 33065, United States
Research Site | Coral Springs, Florida, 33071, United States
Research Site | Doral, Florida, 33166, United States
Research Site | Edgewater, Florida, 32132, United States
Research Site | Hialeah, Florida, 33010, United States
Research Site #1 | Hialeah, Florida, 33012, United States
Research Site #2 | Hialeah, Florida, 33012, United States
Research Site #3 | Hialeah, Florida, 33012, United States
Research Site | Hialeah, Florida, 33018, United States
Research Site #1 | Hollywood, Florida, 33024, United States
Research Site #2 | Hollywood, Florida, 33024, United States
Research Site | Jacksonville, Florida, 32204, United States
Research Site #1 | Jacksonville, Florida, 32216, United States
Research Site #2 | Jacksonville, Florida, 32216, United States
Research Site | Lake Worth, Florida, 33467, United States
Research Site | Lauderdale Lakes, Florida, 33313, United States
Research Site | Miami Beach, Florida, 33140, United States
Research Site | Miami Lakes, Florida, 33014, United States
Research Site #1 | Miami Lakes, Florida, 33016, United States
Research Site #2 | Miami Lakes, Florida, 33016, United States
Research Site | Miami, Florida, 33122, United States
Research Site | Miami, Florida, 33125-4141, United States
Research Site #1 | Miami, Florida, 33126, United States
Research Site #2 | Miami, Florida, 33126, United States
Research Site | Miami, Florida, 33133, United States
Research Site | Miami, Florida, 33134, United States
Research Site | Miami, Florida, 33135, United States
Research Site | Miami, Florida, 33143, United States
Research Site #1 | Miami, Florida, 33144, United States
Research Site #2 | Miami, Florida, 33144, United States
Research Site | Miami, Florida, 33145, United States
Research Site | Miami, Florida, 33150, United States
Research Site | Miami, Florida, 33157, United States
Research Site | Miami, Florida, 33165, United States
Research Site | Miami, Florida, 33169, United States
Research Site | Miami, Florida, 33173, United States
Research Site #1 | Miami, Florida, 33175, United States
Research Site #2 | Miami, Florida, 33175, United States
Research Site | Pembroke Pines, Florida, 33026, United States
Research Site | Pompano Beach, Florida, 33060, United States
Research Site | Port Charlotte, Florida, 33952, United States
Research Site | Tampa, Florida, 33604, United States
Research Site | Tampa, Florida, 33612, United States
Research Site | Tampa, Florida, 33614, United States
Research Site | Atlanta, Georgia, 30338, United States
Research Site | Atlanta, Georgia, 30342, United States
Research Site | Atlanta, Georgia, 30350, United States
Research Site | Augusta, Georgia, 30909, United States
Research Site | Columbus, Georgia, 31901, United States
Research Site #1 | Columbus, Georgia, 31904, United States
Research Site #2 | Columbus, Georgia, 31904, United States
Research Site #1 | Lawrenceville, Georgia, 30046, United States
Research Site #2 | Lawrenceville, Georgia, 30046, United States
Research Site | Macon, Georgia, 31217, United States
Research Site | Meridian, Idaho, 83642, United States
Research Site | Chicago, Illinois, 60637, United States
Research Site | Elk Grove Village, Illinois, 60007, United States
Research Site | Evanston, Illinois, 60201, United States
Research Site | McHenry, Illinois, 60050, United States
Research Site | Peoria, Illinois, 61603, United States
Research Site | Anderson, Indiana, 46011, United States
Research Site | Fort Wayne, Indiana, 46804, United States
Research Site | Jeffersonville, Indiana, 47130, United States
Research Site #1 | Merrillville, Indiana, 46410, United States
Research Site #2 | Merrillville, Indiana, 46410, United States
Research Site | Michigan City, Indiana, 46360, United States
Research Site | Muncie, Indiana, 47304, United States
Research Site | Monroe, Louisiana, 71201, United States
Research Site | New Orleans, Louisiana, 70115, United States
Research Site | Shreveport, Louisiana, 71101, United States
Research Site | Shreveport, Louisiana, 71103, United States
Research Site | Portland, Maine, 04102, United States
Research Site | Baltimore, Maryland, 21218, United States
Research Site | Greenbelt, Maryland, 20770, United States
Research Site | Takoma Park, Maryland, 20912, United States
Research Site | Methuen, Massachusetts, 01844, United States
Research Site | Plymouth, Massachusetts, 02360, United States
Research Site | Springfield, Massachusetts, 01107, United States
Research Site | Detroit, Michigan, 48202, United States
Research Site | Pontiac, Michigan, 48341, United States
Research Site | Port Huron, Michigan, 91344, United States
Research Site | Roseville, Michigan, 48066, United States
Research Site | Minneapolis, Minnesota, 55404, United States
Research Site | Saint Paul, Minnesota, 55102, United States
Research Site | Gulfport, Mississippi, 39501, United States
Research Site | Columbia, Missouri, 65201, United States
Research Site | Kansas City, Missouri, 64111, United States
Research Site | Kansas City, Missouri, 64128, United States
Research Site | Butte, Montana, 59701, United States
Research Site | Lincoln, Nebraska, 68510, United States
Research Site | Omaha, Nebraska, 68124, United States
Research Site #1 | Las Vegas, Nevada, 89106, United States
Research Site #2 | Las Vegas, Nevada, 89106, United States
Research Site | Portsmouth, New Hampshire, 03801, United States
Research Site | Berlin, New Jersey, 08009, United States
Research Site | Voorhees, New Jersey, 08043, United States
Research Site | Albuquerque, New Mexico, 87106, United States
Research Site | Albuquerque, New Mexico, 87108, United States
Research Site | Albuquerque, New Mexico, 87109, United States
Research Site | Santa Fe, New Mexico, 87505, United States
Research Site | Bronx, New York, 10467, United States
Research Site | Flushing, New York, 11355, United States
Research Site | Laurelton, New York, 11413, United States
Research Site | Mineola, New York, 11501, United States
Research Site | New York, New York, 10010, United States
Research Site | Asheville, North Carolina, 28801, United States
Research Site #1 | Greenville, North Carolina, 27834, United States
Research Site #2 | Greenville, North Carolina, 27834, United States
Research Site | Jacksonville, North Carolina, 28546, United States
Research Site | Kinston, North Carolina, 28504, United States
Research Site | Morehead City, North Carolina, 28557, United States
Research Site | New Bern, North Carolina, 28560, United States
Research Site | Wilmington, North Carolina, 28401, United States
Research Site | Winston-Salem, North Carolina, 27103, United States
Research Site | Akron, Ohio, 44302, United States
Research Site | Columbus, Ohio, 43203, United States
Research Site | Marion, Ohio, 43302, United States
Research Site | Maumee, Ohio, 43537, United States
Research Site | Portland, Oregon, 97216, United States
Research Site | Doylestown, Pennsylvania, 18901, United States
Research Site | Jersey Shore, Pennsylvania, 17740, United States
Research Site | Philadelphia, Pennsylvania, 19140, United States
Research Site | East Providence, Rhode Island, 02915, United States
Research Site | Providence, Rhode Island, 02908, United States
Research Site | Anderson, South Carolina, 29625, United States
Research Site | Columbia, South Carolina, 29203, United States
Research Site | Orangeburg, South Carolina, 29118, United States
Research Site | Sumter, South Carolina, 29150-1900, United States
Research Site | West Columbia, South Carolina, 29169, United States
Research Site | Chattanooga, Tennessee, 37408, United States
Research Site | Knoxville, Tennessee, 37923, United States
Research Site | Memphis, Tennessee, 38104, United States
Research Site | Nashville, Tennessee, 37205, United States
Research Site | Arlington, Texas, 76015, United States
Research Site | Dallas, Texas, 75220, United States
Research Site | Dallas, Texas, 75390, United States
Research Site | DeSoto, Texas, 75115, United States
Research Site | El Paso, Texas, 79935, United States
Research Site | Fort Worth, Texas, 76104, United States
Research Site | Gonzales, Texas, 78629, United States
Research Site | Greenville, Texas, 75401, United States
Research Site | Greenville, Texas, 75402, United States
Research Site | Houston, Texas, 33143, United States
Research Site #1 | Houston, Texas, 77004, United States
Research Site #2 | Houston, Texas, 77004, United States
Research Site | Houston, Texas, 77054, United States
Research Site | Lewisville, Texas, 75057, United States
Research Site #1 | McAllen, Texas, 78503, United States
Research Site #2 | McAllen, Texas, 78503, United States
Research Site | McKinney, Texas, 75069, United States
Research Site | McKinney, Texas, 75071, United States
Research Site | Plano, Texas, 75024-5327, United States
Research Site | San Antonio, Texas, 78207, United States
Research Site | San Antonio, Texas, 78212-4740, United States
Research Site | San Antonio, Texas, 78224, United States
Research Site | San Antonio, Texas, 78240-1501, United States
Research Site | Sherman, Texas, 75090, United States
Research Site | Victoria, Texas, 77901, United States
Research Site | Clinton, Utah, 84015, United States
Research Site | Saint George, Utah, 84790, United States
Research Site | Salt Lake City, Utah, 84115, United States
Research Site | Burlington, Vermont, 05401, United States
Research Site | Alexandria, Virginia, 22304, United States
Research Site | Arlington, Virginia, 22207, United States
Research Site | Danville, Virginia, 24541, United States
Research Site | Hampton, Virginia, 23666, United States
Research Site | Lansdowne Town Center, Virginia, 20176, United States
Research Site | Norfolk, Virginia, 23507, United States
Research Site | Salem, Virginia, 24153, United States
Research Site | Woodbridge, Virginia, 22191, United States
Research Site | Tacoma, Washington, 98405, United States
Research Site | Wenatchee, Washington, 98801, United States
Research Site | Madison, Wisconsin, 53705, United States
Research Site | Bahia Blanca, Buenos Aires, B8001HXM, Argentina
Research Site | Junin, Buenos Aires, 6000, Argentina
Research Site | Junin, Buenos Aires, B6000BHA, Argentina
Research Site | Mar del Plata, Buenos Aires, B7600FYK, Argentina
Research Site | Mar del Plata, Buenos Aires, B7600FZ, Argentina
Research Site | Mar del Plata, Buenos Aires, B7602DCK, Argentina
Research Site | Pergamino, Buenos Aires, B2700CPM, Argentina
Research Site | Ramos Mejia, Buenos Aires, B1704ETD, Argentina
Research Site | San Miguel, Buenos Aires, B1663CNJ, Argentina
Research Site | San Nicolas, Buenos Aires, B2900DMH, Argentina
Research Site | Sarandi, Buenos Aires, B1872EEA, Argentina
Research Site | Temperley, Buenos Aires, 1834, Argentina
Research Site | Godoy Cruz, Mendoza, 5501, Argentina
Research Site | Rosario, Santa Fe, S2000DIF, Argentina
Research Site | Rosario, Santa Fe, S2000DNM, Argentina
Research Site | San Miguel de Tucuman, Tucuman, 4000, Argentina
Research Site | San Miguel de Tucuman, Tucuman, T4000AXL, Argentina
Research Site | San Miguel de Tucuman, Tucuman, T4000ICL, Argentina
Research Site | San Miguel de Tucuman, Tucuman, T4000, Argentina
Research Site | Ciudad Autonoma Buenos Aires, C1093AAS, Argentina
Research Site | Ciudad Autonoma Buenos Aires, C1430CKE, Argentina
Research Site | Cordoba, 5000, Argentina
Research Site | Cordoba, X5000AAW, Argentina
Research Site | Cordoba, X5000EVQ, Argentina
Research Site | Cordoba, X5020AAA, Argentina
Research Site | Corrientes, 3400, Argentina
Research Site | Salta, 4406, Argentina
Research Site | San Luis, 5700, Argentina
Research Site | Camperdown, New South Wales, 2050, Australia
Research Site | Liverpool, New South Wales, 2170, Australia
Research Site | Westmead, New South Wales, 2145, Australia
Research Site | Cairns, Queensland, 4870, Australia
Research Site | Gold Coast, Queensland, 9726, Australia
Research Site | Adelaide, South Australia, 5000, Australia
Research Site | Launceston, Tasmania, 7250, Australia
Research Site | Bentleigh East, Victoria, 3165, Australia
Research Site | Box Hill, Victoria, 3128, Australia
Research Site | Fitzroy, Victoria, 3065, Australia
Research Site | Nedlands, Western Australia, 6009, Australia
Research Site | Perth, Western Australia, 6000, Australia
Research Site | St. Pölten, 3100, Austria
Research Site | Wien, 1030, Austria
Research Site | Wien, 1220, Austria
Research Site | Feira de Santana, Bahia, 44001-584, Brazil
Research Site | Itabuna, Bahia, 45600-625, Brazil
Research Site | Salvador, Bahia, 40451-065, Brazil
Research Site | Fortaleza, Ceará, 60115-282, Brazil
Research Site | Fortaleza, Ceará, 60430-370, Brazil
Research Site | Vitória, Espírito Santo, 29055-450, Brazil
Research Site | Belo Horizonte, Minas Gerais, 30150-320, Brazil
Research Site | Juiz de Fora, Minas Gerais, 36036-330, Brazil
Research Site | Curitiba, Paraná, 80230-130, Brazil
Research Site #1 | Curitiba, Paraná, 80810-040, Brazil
Research Site #2 | Curitiba, Paraná, 80810-040, Brazil
Research Site | Maringá, Paraná, 87060-040, Brazil
Research Site | Rio de Janeiro, Rio Do Janeiro, 20551-030, Brazil
Research Site | Caxias do Sul, Rio Grande Do Sul, 95010-005, Brazil
Research Site | Porto Alegre, Rio Grande Do Sul, 90035-074, Brazil
Research Site | Porto Alegre, Rio Grande Do Sul, 90035-903, Brazil
Research Site | Porto Alegre, Rio Grande Do Sul, 90160-093, Brazil
Research Site | Porto Alegre, Rio Grande Do Sul, 90610-000, Brazil
Research Site | Criciúma, Santa Catarina, 88801-250, Brazil
Research Site | Joinville, Santa Catarina, 89202-050, Brazil
Research Site | Botucatu, Sao Paulo, 18618-970, Brazil
Research Site | Campinas, Sao Paulo, 13087-567, Brazil
Research Site | Santo André, Sao Paulo, 09080-110, Brazil
Research Site | Santo André, Sao Paulo, 09090-790, Brazil
Research Site | São Bernardo do Campo, Sao Paulo, 09715-090, Brazil
Research Site | São Paulo, Sao Paulo, 01141-020, Brazil
Research Site | São Paulo, Sao Paulo, 01406-200, Brazil
Research Site | São Paulo, Sao Paulo, 04025-011, Brazil
Research Site | São Paulo, Sao Paulo, 05403-000, Brazil
Research Site | Byala, 7100, Bulgaria
Research Site | Cherven bryag, 5980, Bulgaria
Research Site | Lom, 3600, Bulgaria
Research Site | Silistra, 7500, Bulgaria
Research Site | Sliven, 8800, Bulgaria
Research Site | Smolyan, 4700, Bulgaria
Research Site | Sofia, 1233, Bulgaria
Research Site | Sofia, 1407, Bulgaria
Research Site #1 | Sofia, 1431, Bulgaria
Research Site #2 | Sofia, 1431, Bulgaria
Research Site | Sofia, 1606, Bulgaria
Research Site | Sofia, 1784, Bulgaria
Research Site | Stara Zagora, 6000, Bulgaria
Research Site | Varna, 9000, Bulgaria
Research Site | Varna, 9002, Bulgaria
Research Site | Veliko Tarnovo, 5000, Bulgaria
Research Site | Vratsa, 3000, Bulgaria
Research Site | Scarborough, Ontario, M1H 3G4, Canada
Research Site | Concepción, 4030000, Chile
Research Site | Puerto Varas, 5550170, Chile
Research Site | Santiago, 8431657, Chile
Research Site | Temuco, 4780000, Chile
Research Site | Barranquilla, 080020, Colombia
Research Site | Bogota, 110221, Colombia
Research Site | Espinal, 00000, Colombia
Research Site | Manizales, 170004, Colombia
Research Site #1 | Medellin, 050021, Colombia
Research Site #2 | Medellin, 050021, Colombia
Research Site | Medellín, 500515, Colombia
Research Site | Ceske Budejovice, 370 01, Czechia
Research Site | Hradec Kralove, 50333, Czechia
Research Site | Praha 2, 128 08, Czechia
Research Site | Praha 4, 140 21, Czechia
Research Site | Lille, Alpes De Haute Provence, 59000, France
Research Site | Saint-Priest-En-Jarez, Loire, 42055, France
Research Site | Reims Cedex, Marne, 51090, France
Research Site | Pontoise, Val d'Oise, 95300, France
Research Site | Créteil Cedex, Val De Marne, 94010, France
Research Site | Paris, 75015, France
Research Site | Paris, 75020, France
Research Site | Villingen-Schwenningen, Baden Wuerttemberg, 78052, Germany
Research Site | Rostock, Mecklenburg Vorpommern, 18057, Germany
Research Site | Duesseldorf, Nordrhein Westfalen, 40210, Germany
Research Site | Berlin, 10117, Germany
Research Site | Berlin, 12627, Germany
Research Site | Hamburg, 22297, Germany
Research Site #1 | Baja, 6500, Hungary
Research Site #2 | Baja, 6500, Hungary
Research Site | Balatonfured, 8230, Hungary
Research Site | Budapest, 1076, Hungary
Research Site | Budapest, 1145, Hungary
Research Site | Debrecen, 4032, Hungary
Research Site | Esztergom, 2500, Hungary
Research Site | Hodmezovasarhely, 6800, Hungary
Research Site | Kalocsa, 6300, Hungary
Research Site | Kaposvar, 7400, Hungary
Research Site | Kecskemet, 6000, Hungary
Research Site | Kistarcsa, 2143, Hungary
Research Site | Pecs, 7623, Hungary
Research Site | Szeged, 6720, Hungary
Research Site | Szigetvar, 7900, Hungary
Research Site | Ashkelon, 78278, Israel
Research Site | Haifa, 3109601, Israel
Research Site | Nahariya, 2210001, Israel
Research Site | Ramat Gan, 52363, Israel
Research Site | Rishon Lezion, 75141, Israel
Research Site | Piedimonte Matese, Caserta, 81016, Italy
Research Site | San Giovanni Rotondo, Foggia, 71013, Italy
Research Site | Bari, 70124, Italy
Research Site | Lecco, 23900, Italy
Research Site | Milano, 20142, Italy
Research Site | Milano, 20162, Italy
Research Site #1 | Napoli, 80138, Italy
Research Site #2 | Napoli, 80138, Italy
Research Site | Parma, 43100, Italy
Research Site | Pavia, 27100, Italy
Research Site | Roma, 00168, Italy
Research Site | Siena, 53100, Italy
Research Site | Bucheon-si, Gyeonggi-do, 14647, Korea, Republic of
Research Site | Goyang-si, Gyeonggi-do, 10380, Korea, Republic of
Research Site | Guri-si, Gyeonggi-do, 11923, Korea, Republic of
Research Site | Seongnam-si, Gyeonggi-do, 13620, Korea, Republic of
Research Site | Busan, 47392, Korea, Republic of
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Research Site | Daegu, 41944, Korea, Republic of
Research Site | Seoul, 02841, Korea, Republic of
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Research Site | Alor Setar, Kedah, 05460, Malaysia
Research Site | Kuala Lumpur, 56000, Malaysia
Research Site | Kuala Lumpur, 59100, Malaysia
Research Site | Pulau Pinang, 10990, Malaysia
Research Site | Torreon, Coahuila, 27000, Mexico
Research Site | Mexico, Distrito Federal, 06100, Mexico
Research Site | Mexico, Distrito Federal, 06700, Mexico
Research Site | Acapulco de Juarez, Guerrero, 39670, Mexico
Research Site #1 | Pachuca, Hidalgo, 42070, Mexico
Research Site #2 | Pachuca, Hidalgo, 42070, Mexico
Research Site | Guadalajara, Jalisco, 44130, Mexico
Research Site | Zapopan, Jalisco, 45030, Mexico
Research Site | Zapopan, Jalisco, 45116, Mexico
Research Site | Zapopan, Jalisco, 45200, Mexico
Research Site | Morelia, Michoacán, 58260, Mexico
Research Site | Monterrey, Nuevo León, 64620, Mexico
Research Site | Monterrey, Nuevo León, 64710, Mexico
Research Site | San Juan del Rio, Queretaro, 76800, Mexico
Research Site | Culiacan, Sinaloa, 80200, Mexico
Research Site | Culiacan, Sinaloa, 80230, Mexico
Research Site | Culiacán, Sinaloa, 80030, Mexico
Research Site | Mazatlan, Sinaloa, 82110, Mexico
Research Site | Chihuahua, 31203, Mexico
Research Site | Chihuahua, 31217, Mexico
Research Site | Durango, 34000, Mexico
Research Site | Veracruz, 91900, Mexico
Research Site | Hamilton, 3200, New Zealand
Research Site | New Plymouth, 4342, New Zealand
Research Site | Nowa Sol, 67-100, Poland
Research Site | Caguas, 00725, Puerto Rico
Research Site | Bucuresti, 010719, Romania
Research Site | Bucuresti, 011794, Romania
Research Site #1 | Bucuresti, 022328, Romania
Research Site #2 | Bucuresti, 022328, Romania
Research Site | Bucuresti, 042122, Romania
Research Site | Oradea, 410469, Romania
Research Site | Timisoara, 300182, Romania
Research Site | Kazan, 420012, Russian Federation
Research Site | Kemerovo, 650066, Russian Federation
Research Site | Krasnoyarsk, 660062, Russian Federation
Research Site | Nizhniy Novgorod, 603076, Russian Federation
Research Site | Novosibirsk, 630054, Russian Federation
Research Site | Novosibirsk, 630091, Russian Federation
Research Site | Petrozavodsk, 185019, Russian Federation
Research Site | Pushkin, 196603, Russian Federation
Research Site | Saint-Petersburg, 195271, Russian Federation
Research Site | Saint-Petersburg, 197022, Russian Federation
Research Site | Yaroslavl, 150062, Russian Federation
Research Site #1 | Belgrade, 11000, Serbia
Research Site #2 | Belgrade, 11000, Serbia
Research Site #3 | Belgrade, 11000, Serbia
Research Site | Kragujevac, 34000, Serbia
Research Site | Lazarevac, 11000, Serbia
Research Site | Nis, 18000, Serbia
Research Site | Zajecar, 19000, Serbia
Research Site | Bardejov, 08501, Slovakia
Research Site | Bratislava, 83103, Slovakia
Research Site | Galanta, 924 22, Slovakia
Research Site | Svidnik, 08901, Slovakia
Research Site | Trstena, 02801, Slovakia
Research Site | Bloemfontein, Free State, 9301, South Africa
Research Site | Brandfort, Free State, 9400, South Africa
Research Site | Pretoria, Gauteng, 0002, South Africa
Research Site | Pretoria, Gauteng, 1692, South Africa
Research Site | Vereeniging, Gauteng, 1935, South Africa
Research Site #1 | Durban, KwaZulu-Natal, 4001, South Africa
Research Site #2 | Durban, KwaZulu-Natal, 4001, South Africa
Research Site | Durban, KwaZulu-Natal, 4092, South Africa
Research Site | Durban, KwaZulu-Natal, 4320, South Africa
Research Site | Tongaat, KwaZulu-Natal, 4399, South Africa
Research Site | Worcester, Western Cape, 6850, South Africa
Research Site | Elche, Alicante, 03293, Spain
Research Site | Torrevieja, Alicante, 03186, Spain
Research Site | Palma de Mallorca, Baleares, 07120, Spain
Research Site | L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Research Site | Malaga, Málaga, 29010, Spain
Research Site | Almeria, 04007, Spain
Research Site | Almeria, 04009, Spain
Research Site | Badajoz, 06006, Spain
Research Site | Barcelona, 08003, Spain
Research Site | Barcelona, 08025, Spain
Research Site | Barcelona, 08035, Spain
Research Site | Madrid, 28007, Spain
Research Site | Madrid, 28040, Spain
Research Site | Madrid, 28041, Spain
Research Site | Pamplona, 31001, Spain
Research Site | Sevilla, 41013, Spain
Research Site | Sevilla, 41071, Spain
Research Site | Valencia, 46014, Spain
Research Site | Valencia, 46026, Spain
Research Site | Ankara, 06100, Turkey
Research Site | Erciyes, 38039, Turkey
Research Site | Istanbul, 34098, Turkey
Research Site | Istanbul, 34722, Turkey
Research Site | Kocaeli, 41380, Turkey
Research Site | Dnipro, 49005, Ukraine
Research Site | Ivano-Frankivsk, 76008, Ukraine
Research Site | Ivano-Frankivsk, 76018, Ukraine
Research Site | Kharkiv, 61037, Ukraine
Research Site | Kharkiv, 61039, Ukraine
Research Site | Kharkiv, 61103, Ukraine
Research Site | Kharkiv, 61157, Ukraine
Research Site | Kropyvnytskyi, 25006, Ukraine
Research Site | Kyiv, 02125, Ukraine
Research Site | Kyiv, 04050, Ukraine
Research Site | Lutsk, 43005, Ukraine
Research Site | Lviv, 79013, Ukraine
Research Site | Mykolaiv, 54058, Ukraine
Research Site | Odesa, 65025, Ukraine
Research Site | Vinnytsia, 21001, Ukraine
Research Site | Vinnytsia, 21005, Ukraine
Research Site | Vinnytsia, 21018, Ukraine
Research Site | Zaporizhzhia, 69118, Ukraine
Research Site | Exeter, Devon, EX2 5DW, United Kingdom
Research Site | London, Greater London, E1 1BB, United Kingdom
Research Site | London, Greater London, SE5 9RS, United Kingdom
Research Site | Salford, Greater Manchester, M6 8HD, United Kingdom
Research Site | Stevenage, Hertfordshire, SG1 4AB, United Kingdom
Research Site | Leicester, Leicestershire, LE5 4PW, United Kingdom
Research Site | King's Lynn, Norfolk, PE30 4ET, United Kingdom
Research Site | Doncaster, South Yorkshire, DN2 5LT, United Kingdom
Research Site | Swansea, SA6 6NL, United Kingdom
Location Countries

Argentina

Australia

Austria

Brazil

Bulgaria

Canada

Chile

Colombia

Czechia

France

Germany

Hungary

Israel

Italy

Korea, Republic of

Malaysia

Mexico

New Zealand

Poland

Puerto Rico

Romania

Russian Federation

Serbia

Slovakia

South Africa

Spain

Turkey

Ukraine

United Kingdom

United States

Verification Date

June 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: vadadustat

Type: Experimental

Label: darbepoetin alfa

Type: Active Comparator

Acronym PRO2TECT
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov