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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02865850




Registration number
NCT02865850
Ethics application status
Date submitted
8/08/2016
Date registered
15/08/2016
Date last updated
18/07/2022

Titles & IDs
Public title
Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)
Scientific title
Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction or Maintenance Treatment of Anemia in Subjects With Incident Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE - CORRECTION/CONVERSION)
Secondary ID [1] 0 0
2016-000838-21
Secondary ID [2] 0 0
AKB-6548-CI-0016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia 0 0
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 176 weeks
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 176 weeks
Secondary outcome [3] 0 0
Median Time to First Cardiovascular MACE
Timepoint [3] 0 0
Up to 176 weeks
Secondary outcome [4] 0 0
Median Time to First Cardiovascular Death
Timepoint [4] 0 0
Up to 176 weeks
Secondary outcome [5] 0 0
Median Time to First All-cause Mortality
Timepoint [5] 0 0
Up to 176 weeks

Eligibility
Key inclusion criteria
- =18 years of age

- Initiated chronic maintenance dialysis (either peritoneal or hemodialysis) for
end-stage kidney disease within 16 weeks prior to Screening

- Mean Screening hemoglobin between 8.0 and <11.0 grams per deciliter (g/dL) (inclusive)

- Serum ferritin =100 nanograms per deciliter (ng/mL) and 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 chronic kidney disease or participants with active
bleeding or recent blood loss

- Red blood cells transfusion within 8 weeks prior to randomization

- Anticipated to recover adequate kidney function to no longer require dialysis

- Uncontrolled hypertension

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

- Acute coronary syndrome (hospitalization for unstable angina, 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
congestive heart failure; or stroke within 12 weeks prior to or during Screening.

- Participants meeting the criteria of erythropoiesis-stimulating agent resistance
within 8 weeks prior to or during Screening defined as follows

1. epoetin: > 7700 units/dose three times per week or >23,000 units per week

2. Darbepoetin alfa: >100 micrograms per week (mcg/week)

3. methoxy polyethylene glycol-epoetin beta: >100 micrograms (mcg) every other week
or >200 mcg/month

- Hypersensitivity to Vadadustat, Darbepoetin alfa or 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
1/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/03/2020
Sample size
Target
Accrual to date
Final
369
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
State/province [3] 0 0
California
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United States of America
State/province [4] 0 0
Colorado
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United States of America
State/province [5] 0 0
Connecticut
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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United States of America
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Maryland
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Michigan
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Missouri
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New Mexico
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New York
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North Carolina
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Pennsylvania
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Tennessee
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Texas
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Corrientes
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Salta
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Argentina
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San Luis
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Ceará
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Minas Gerais
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Paraná
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Rio Grande Do Sul
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Santa Catarina
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Sao Paulo
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Germany
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Baden Wuerttemberg
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Germany
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Mecklenburg Vorpommern
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Germany
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Nordrhein Westfalen
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Foggia
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Italy
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Genova
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Italy
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Lecco
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Italy
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Napoli
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Pavia
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Italy
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Roma
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Siena
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Korea, Republic of
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Gangwon-do
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Gyeonggi-do
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Korea, Republic of
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Busan
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Seoul
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Jalisco
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Lodz
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Leiria
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Loures
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Russian Federation
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Kemerovo
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Ukraine
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Brovary
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Cherkassy
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Dnipro
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Ivano-Frankivsk
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Kharkiv
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Kyiv
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Ternopil
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Uzhgorod
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Vinnytsia
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Zaporizhzhia
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Ukraine
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Zhytomyr

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 correction or
maintenance treatment of anemia in participants with incident dialysis-dependent chronic
kidney disease (DD-CKD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02865850
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Chief Medical Officer
Address 0 0
Akebia Therapeutics Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries