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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02648347




Registration number
NCT02648347
Ethics application status
Date submitted
4/01/2016
Date registered
7/01/2016
Date last updated
11/06/2021

Titles & IDs
Public title
Efficacy and Safety Study to Evaluate Vadadustat for the Correction of Anemia in Subjects 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 Correction of Anemia in Subjects With Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CORRECTION)
Secondary ID [1] 0 0
2015-004265-81
Secondary ID [2] 0 0
AKB-6548-CI-0014
Universal Trial Number (UTN)
Trial acronym
PRO2TECT
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 tablet

Treatment: Drugs: darbepoetin alfa
Subcutaneous

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change in Hb between baseline and the primary evaluation period
Timepoint [1] 0 0
Baseline visit, Week 36
Primary outcome [2] 0 0
Major adverse cardiovascular events (MACE), defined as all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke
Timepoint [2] 0 0
From Baseline visit to end of study (event-driven, minimum 1 year)
Secondary outcome [1] 0 0
Mean change in Hb value between Baseline and the secondary evaluation period
Timepoint [1] 0 0
Baseline visit, Week 52
Secondary outcome [2] 0 0
Proportion of subjects with Hb values within the target range during the primary evaluation period
Timepoint [2] 0 0
Baseline visit, Week 36
Secondary outcome [3] 0 0
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [3] 0 0
From Baseline visit to end of study (event-driven, minimum 1 year)
Secondary outcome [4] 0 0
Proportion of time with Hb values within the target range during the primary evaluation period
Timepoint [4] 0 0
Baseline visit, Week 36
Secondary outcome [5] 0 0
Proportion of time with Hb values within the target range during the secondary evaluation period
Timepoint [5] 0 0
Baseline visit, Week 52
Secondary outcome [6] 0 0
Proportion of subjects with Hb values within the target range during the secondary evaluation period
Timepoint [6] 0 0
Baseline visit, Week 52
Secondary outcome [7] 0 0
Proportion of subjects with Hb increase of >1.0 g/dL from Baseline
Timepoint [7] 0 0
From baseline visit to end of study (event-driven, minimum 36 weeks)
Secondary outcome [8] 0 0
Time to achieve Hb increase of >1.0g/dL from Baseline
Timepoint [8] 0 0
From baseline visit to end of study (event-driven, minimum 36 weeks)
Secondary outcome [9] 0 0
Mean change in Hb between Baseline (mean pretreatment Hgb) and the primary evaluation period (mean Hgb from Weeks 24-36) stratified by pre-baseline ESA exposure
Timepoint [9] 0 0
Baseline visit, Week 36
Secondary outcome [10] 0 0
Proportion of subjects receiving IV iron therapy
Timepoint [10] 0 0
Baseline visit, Week 52
Secondary outcome [11] 0 0
Mean monthly dose of IV elemental iron administered in subjects who have received IV iron
Timepoint [11] 0 0
Baseline visit, Week 52
Secondary outcome [12] 0 0
Proportion of subjects receiving RBC transfusion(s)
Timepoint [12] 0 0
Baseline visit, Week 52

Eligibility
Key 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

- Mean Screening hemoglobin <10.0 g/dL
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Anemia due to a cause other than CKD or subjects with active bleeding or recent blood
loss

- Any erythropoietic stimulating agent 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
HF, 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Liverpool
Recruitment hospital [3] 0 0
Research Site - Cairns
Recruitment hospital [4] 0 0
Research Site - Gold Coast
Recruitment hospital [5] 0 0
Research Site - Herston
Recruitment hospital [6] 0 0
Research Site - Adelaide
Recruitment hospital [7] 0 0
Research Site - Bedford Park
Recruitment hospital [8] 0 0
Research Site - Box Hill
Recruitment hospital [9] 0 0
Research Site - Nedlands
Recruitment hospital [10] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4870 - Cairns
Recruitment postcode(s) [4] 0 0
9726 - Gold Coast
Recruitment postcode(s) [5] 0 0
4006 - Herston
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment postcode(s) [10] 0 0
6000 - Perth
Recruitment outside Australia
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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 of
anemia and maintenance of hemoglobin (Hb) in subjects with NDD-CKD
Trial website
https://clinicaltrials.gov/show/NCT02648347
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Akebia Therapeutics
Address 0 0
Sponsor GmbH
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

Summary results
Other publications