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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02680574




Registration number
NCT02680574
Ethics application status
Date submitted
9/02/2016
Date registered
11/02/2016
Date last updated
27/06/2022

Titles & IDs
Public title
Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
Scientific 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)
Secondary ID [1] 0 0
2015-004774-14
Secondary ID [2] 0 0
AKB-6548-CI-0015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia 0 0
Non-Dialysis-Dependent Chronic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vadadustat
Treatment: Drugs - Darbepoetin alfa

Experimental: Vadadustat -

Active comparator: Darbepoetin alfa -


Treatment: Drugs: Vadadustat
Oral dose administered once daily for =36 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.

Treatment: Drugs: Darbepoetin alfa
Subcutaneous or intravenous dose administered for =36 weeks. Initial dose based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)
Timepoint [1] 0 0
Baseline; Weeks 24 to 36
Primary outcome [2] 0 0
Median Time to First Major Adverse Cardiovascular Event (MACE)
Timepoint [2] 0 0
Up to Week 208
Secondary outcome [1] 0 0
Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52)
Timepoint [1] 0 0
Baseline; Weeks 40 to 52
Secondary outcome [2] 0 0
Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis
Timepoint [2] 0 0
Up to Week 208
Secondary outcome [3] 0 0
Median Time to First Cardiovascular MACE
Timepoint [3] 0 0
Up to Week 208
Secondary outcome [4] 0 0
Median Time to First Cardiovascular Death
Timepoint [4] 0 0
Up to Week 208
Secondary outcome [5] 0 0
Median Time to First All-cause Mortality
Timepoint [5] 0 0
Up to Week 208

Eligibility
Key inclusion criteria
* =18 years of age
* Diagnosis of chronic kidney disease (CKD) with an estimated glomerular filtration rate =60 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) at Screening and not expected to start dialysis within 6 months of Screening
* Currently maintained on erythropoiesis-stimulating agents therapy, with a dose received within 6 weeks prior to or during Screening
* Mean Screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the United States (US) and between 9.0 and 12.0 g/dL (inclusive) outside of the US
* Serum ferritin =100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) =20% during Screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Anemia due to a cause other than CKD or participant with active bleeding or recent blood loss
* Red blood cell transfusion within 8 weeks prior to randomization
* 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 heart failure, or stroke within 12 weeks prior to or during Screening
* Hypersensitivity to Darbepoetin or Vadadustat or to any of their excipients

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2020
Sample size
Target
Accrual to date
Final
1725
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Liverpool
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Research Site - Westmead
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Research Site - Bentleigh East
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Research Site - Box Hill
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Research Site - Fitzroy
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Research Site - Nedlands
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Research Site - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
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2170 - Liverpool
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2145 - Westmead
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4870 - Cairns
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9726 - Gold Coast
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5000 - Adelaide
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7250 - Launceston
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3165 - Bentleigh East
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3128 - Box Hill
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3065 - Fitzroy
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment postcode(s) [12] 0 0
6000 - Perth
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Akebia Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
Trial website
https://clinicaltrials.gov/study/NCT02680574
Trial related presentations / publications
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Chertow GM, Pergola PE, Farag YMK, Agarwal R, Arnold S, Bako G, Block GA, Burke S, Castillo FP, Jardine AG, Khawaja Z, Koury MJ, Lewis EF, Lin T, Luo W, Maroni BJ, Matsushita K, McCullough PA, Parfrey PS, Roy-Chaudhury P, Sarnak MJ, Sharma A, Spinowitz B, Tseng C, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Eckardt KU; PRO2TECT Study Group. Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD. N Engl J Med. 2021 Apr 29;384(17):1589-1600. doi: 10.1056/NEJMoa2035938.
Public notes

Contacts
Principal investigator
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Akebia Therapeutics Inc.
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02680574