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Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT)

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ClinicalTrials.gov Identifier: NCT02680574
Recruitment Status : Active, not recruiting
First Posted : February 11, 2016
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Anemia Non-dialysis-dependent Chronic Kidney Disease Drug: vadadustat Drug: darbepoetin alfa Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1752 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : February 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

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Arm Intervention/treatment
Experimental: vadadustat Drug: vadadustat
oral tablet
Other Name: AKB-6548

Active Comparator: darbepoetin alfa Drug: darbepoetin alfa
Subcutaneous
Other Name: aranesp




Primary Outcome Measures :
  1. Mean change in Hb between baseline and the primary evaluation period [ Time Frame: Baseline visit, Week 36 ]
  2. Major adverse cardiovascular events (MACE), defined as all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke [ Time Frame: From Baseline visit to end of study (event-driven, minimum 1 year) ]

Secondary Outcome Measures :
  1. Mean change in Hb value between Baseline and the secondary evaluation period [ Time Frame: Baseline visit, Week 52 ]
  2. Proportion of subjects with Hb values within the target range during the primary evaluation period [ Time Frame: Baseline visit, Week 36 ]
  3. Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Baseline visit to end of study (event-driven, minimum 1 year) ]
  4. Proportion of time with Hb values within the target range during the primary evaluation period [ Time Frame: Baseline visit, Week 36 ]
  5. Proportion of time with Hb values within the target range during the secondary evaluation period [ Time Frame: Baseline visit, Week 52 ]
  6. Proportion of subjects with Hb values within the target range during the secondary evaluation period [ Time Frame: Baseline visit, Week 52 ]
  7. Proportion of subjects with Hb increase of >1.0 g/dL from Baseline visit [ Time Frame: From baseline visit to end of study (event-driven, minimum 36 weeks) ]
  8. Time to achieve Hb increase of 1.0 g/dL from Baseline visit [ Time Frame: From baseline visit to end of study (event-driven, minimum 36 weeks) ]
  9. 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 [ Time Frame: Baseline visit, Week 36 ]
  10. Proportion of subjects receiving IV iron therapy [ Time Frame: Baseline visit, Week 52 ]
  11. Mean monthly dose of IV elemental iron administered in subjects who have received IV iron [ Time Frame: Baseline visit, Week 52 ]
  12. Proportion of subjects receiving RBC transfusion(s) [ Time Frame: Baseline visit, Week 52 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680574


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Research Site
Milano, Italy, 20162
Research Site #1
Napoli, Italy, 80138
Research Site #2
Napoli, Italy, 80138
Research Site
Parma, Italy, 43100
Research Site
Pavia, Italy, 27100
Research Site
Roma, Italy, 00168
Research Site
Siena, Italy, 53100
Korea, Republic of
Research Site
Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
Research Site
Goyang-si, Gyeonggi-do, Korea, Republic of, 10380
Research Site
Guri-si, Gyeonggi-do, Korea, Republic of, 11923
Research Site
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Research Site
Busan, Korea, Republic of, 47392
Research Site
Busan, Korea, Republic of, 49201
Research Site
Daegu, Korea, Republic of, 41944
Research Site
Seoul, Korea, Republic of, 02841
Research Site
Seoul, Korea, Republic of, 03080
Research Site
Seoul, Korea, Republic of, 06591
Research Site
Seoul, Korea, Republic of, 07345
Research Site
Seoul, Korea, Republic of, 135-710
Malaysia
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Alor Setar, Kedah, Malaysia, 05460
Research Site
Kuala Lumpur, Malaysia, 56000
Research Site
Kuala Lumpur, Malaysia, 59100
Research Site
Pulau Pinang, Malaysia, 10990
Mexico
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Torreon, Coahuila, Mexico, 27000
Research Site
Mexico, Distrito Federal, Mexico, 06100
Research Site
Mexico, Distrito Federal, Mexico, 06700
Research Site
Acapulco de Juarez, Guerrero, Mexico, 39670
Research Site #1
Pachuca, Hidalgo, Mexico, 42070
Research Site #2
Pachuca, Hidalgo, Mexico, 42070
Research Site
Guadalajara, Jalisco, Mexico, 44130
Research Site
Zapopan, Jalisco, Mexico, 45030
Research Site
Zapopan, Jalisco, Mexico, 45116
Research Site
Zapopan, Jalisco, Mexico, 45200
Research Site
Morelia, Michoacán, Mexico, 58260
Research Site
Monterrey, Nuevo León, Mexico, 64620
Research Site
Monterrey, Nuevo León, Mexico, 64710
Research Site
San Juan del Rio, Queretaro, Mexico, 76800
Research Site
Culiacan, Sinaloa, Mexico, 80200
Research Site
Culiacan, Sinaloa, Mexico, 80230
Research Site
Culiacán, Sinaloa, Mexico, 80030
Research Site
Mazatlan, Sinaloa, Mexico, 82110
Research Site
Chihuahua, Mexico, 31203
Research Site
Chihuahua, Mexico, 31217
Research Site
Durango, Mexico, 34000
Research Site
Veracruz, Mexico, 91900
New Zealand
Research Site
Hamilton, New Zealand, 3200
Research Site
New Plymouth, New Zealand, 4342
Poland
Research Site
Nowa Sol, Poland, 67-100
Puerto Rico
Research Site
Caguas, Puerto Rico, 00725
Romania
Research Site
Bucuresti, Romania, 010719
Research Site
Bucuresti, Romania, 011794
Research Site #1
Bucuresti, Romania, 022328
Research Site #2
Bucuresti, Romania, 022328
Research Site
Bucuresti, Romania, 042122
Research Site
Oradea, Romania, 410469
Research Site
Timisoara, Romania, 300182
Russian Federation
Research Site
Kazan, Russian Federation, 420012
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Kemerovo, Russian Federation, 650066
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Krasnoyarsk, Russian Federation, 660062
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Nizhniy Novgorod, Russian Federation, 603076
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Novosibirsk, Russian Federation, 630054
Research Site
Novosibirsk, Russian Federation, 630091
Research Site
Petrozavodsk, Russian Federation, 185019
Research Site
Pushkin, Russian Federation, 196603
Research Site
Saint-Petersburg, Russian Federation, 195271
Research Site
Saint-Petersburg, Russian Federation, 197022
Research Site
Yaroslavl, Russian Federation, 150062
Serbia
Research Site #1
Belgrade, Serbia, 11000
Research Site #2
Belgrade, Serbia, 11000
Research Site #3
Belgrade, Serbia, 11000
Research Site
Kragujevac, Serbia, 34000
Research Site
Lazarevac, Serbia, 11000
Research Site
Nis, Serbia, 18000
Research Site
Zajecar, Serbia, 19000
Slovakia
Research Site
Bardejov, Slovakia, 08501
Research Site
Bratislava, Slovakia, 83103
Research Site
Galanta, Slovakia, 924 22
Research Site
Svidnik, Slovakia, 08901
Research Site
Trstena, Slovakia, 02801
South Africa
Research Site
Bloemfontein, Free State, South Africa, 9301
Research Site
Brandfort, Free State, South Africa, 9400
Research Site
Pretoria, Gauteng, South Africa, 0002
Research Site
Pretoria, Gauteng, South Africa, 1692
Research Site
Vereeniging, Gauteng, South Africa, 1935
Research Site #1
Durban, KwaZulu-Natal, South Africa, 4001
Research Site #2
Durban, KwaZulu-Natal, South Africa, 4001
Research Site
Durban, KwaZulu-Natal, South Africa, 4092
Research Site
Durban, KwaZulu-Natal, South Africa, 4320
Research Site
Tongaat, KwaZulu-Natal, South Africa, 4399
Research Site
Worcester, Western Cape, South Africa, 6850
Spain
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Elche, Alicante, Spain, 03293
Research Site
Torrevieja, Alicante, Spain, 03186
Research Site
Palma de Mallorca, Baleares, Spain, 07120
Research Site
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Research Site
Malaga, Málaga, Spain, 29010
Research Site
Almeria, Spain, 04007
Research Site
Almeria, Spain, 04009
Research Site
Badajoz, Spain, 06006
Research Site
Barcelona, Spain, 08003
Research Site
Barcelona, Spain, 08025
Research Site
Barcelona, Spain, 08035
Research Site
Madrid, Spain, 28007
Research Site
Madrid, Spain, 28040
Research Site
Madrid, Spain, 28041
Research Site
Pamplona, Spain, 31001
Research Site
Sevilla, Spain, 41013
Research Site
Sevilla, Spain, 41071
Research Site
Valencia, Spain, 46014
Research Site
Valencia, Spain, 46026
Turkey
Research Site
Ankara, Turkey, 06100
Research Site
Erciyes, Turkey, 38039
Research Site
Istanbul, Turkey, 34098
Research Site
Istanbul, Turkey, 34722
Research Site
Kocaeli, Turkey, 41380
Ukraine
Research Site
Dnipro, Ukraine, 49005
Research Site
Ivano-Frankivsk, Ukraine, 76008
Research Site
Ivano-Frankivsk, Ukraine, 76018
Research Site
Kharkiv, Ukraine, 61037
Research Site
Kharkiv, Ukraine, 61039
Research Site
Kharkiv, Ukraine, 61103
Research Site
Kharkiv, Ukraine, 61157
Research Site
Kropyvnytskyi, Ukraine, 25006
Research Site
Kyiv, Ukraine, 02125
Research Site
Kyiv, Ukraine, 04050
Research Site
Lutsk, Ukraine, 43005
Research Site
Lviv, Ukraine, 79013
Research Site
Mykolaiv, Ukraine, 54058
Research Site
Odesa, Ukraine, 65025
Research Site
Vinnytsia, Ukraine, 21001
Research Site
Vinnytsia, Ukraine, 21005
Research Site
Vinnytsia, Ukraine, 21018
Research Site
Zaporizhzhia, Ukraine, 69118
United Kingdom
Research Site
Exeter, Devon, United Kingdom, EX2 5DW
Research Site
London, Greater London, United Kingdom, E1 1BB
Research Site
London, Greater London, United Kingdom, SE5 9RS
Research Site
Salford, Greater Manchester, United Kingdom, M6 8HD
Research Site
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
Research Site
Leicester, Leicestershire, United Kingdom, LE5 4PW
Research Site
King's Lynn, Norfolk, United Kingdom, PE30 4ET
Research Site
Doncaster, South Yorkshire, United Kingdom, DN2 5LT
Research Site
Swansea, United Kingdom, SA6 6NL
Sponsors and Collaborators
Akebia Therapeutics
Investigators
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Study Director: Akebia Therapeutics Sponsor GmbH

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Responsible Party: Akebia Therapeutics
ClinicalTrials.gov Identifier: NCT02680574     History of Changes
Other Study ID Numbers: AKB-6548-CI-0015
2015-004774-14 ( EudraCT Number )
First Posted: February 11, 2016    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Akebia Therapeutics:
vadadustat
AKB-6548
Chronic kidney disease
anemia
CKD
chronic renal insufficiency
renal impairment
erythropoietin
kidney
renal
oral anemia treatment
hemoglobin
hypoxia-inducible factor
HIF
hypoxia-inducible factor prolyl-hydroxylase inhibitor
HIF-PHI
efficacy
safety
Phase 3
cardiovascular
NDD-CKD
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Glycine
Hematinics
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs