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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03710291




Registration number
NCT03710291
Ethics application status
Date submitted
11/10/2018
Date registered
18/10/2018

Titles & IDs
Public title
Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis
Scientific title
A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects With Metabolic Acidosis
Secondary ID [1] 0 0
2018-001303-36
Secondary ID [2] 0 0
TRCA-303
Universal Trial Number (UTN)
Trial acronym
VALOR-CKD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Acidosis 0 0
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
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TRC101
Treatment: Drugs - Placebo

Experimental: TRC101 -

Placebo comparator: Placebo -


Treatment: Drugs: TRC101
Oral, non-absorbed, polymeric hydrochloric acid binder

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

Outcomes
Primary outcome [1] 0 0
Progression of chronic kidney disease
Timepoint [1] 0 0
Through study completion, up to approximately 6 years.
Secondary outcome [1] 0 0
Death (all-cause), ESRD or a confirmed =50% reduction in eGFR
Timepoint [1] 0 0
Through study completion, up to approximately 6 years.
Secondary outcome [2] 0 0
Physical functioning (subjective)
Timepoint [2] 0 0
18 months after randomization.
Secondary outcome [3] 0 0
Physical functioning (objective)
Timepoint [3] 0 0
18 months after randomization.
Secondary outcome [4] 0 0
ESRD or renal death
Timepoint [4] 0 0
Through study completion, up to approximately 6 years.
Secondary outcome [5] 0 0
Primary outcome measure OR cardiovascular death
Timepoint [5] 0 0
Through study completion, up to approximately 6 years.
Secondary outcome [6] 0 0
Serum creatinine
Timepoint [6] 0 0
Through study completion, up to approximately 6 years.
Secondary outcome [7] 0 0
=50% reduction in eGFR
Timepoint [7] 0 0
Through study completion, up to approximately 6 years.
Secondary outcome [8] 0 0
=40% reduction in eGFR
Timepoint [8] 0 0
Through study completion, up to approximately 6 years.
Secondary outcome [9] 0 0
All-cause hospitalization
Timepoint [9] 0 0
Through study completion, up to approximately 6 years.
Secondary outcome [10] 0 0
Cardiovascular death
Timepoint [10] 0 0
Through study completion, up to approximately 6 years.
Secondary outcome [11] 0 0
All-cause mortality
Timepoint [11] 0 0
Through study completion, up to approximately 6 years.

Eligibility
Key inclusion criteria
* Estimated glomerular filtration rate (eGFR) 20 - 40 mL/min/1.73m^2.
* Serum bicarbonate 12 - 20 mEq/L.
* On maximum tolerated dose of ACE inhibitor and/or ARB.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Acute metabolic acidosis.
* Anticipated dialysis or kidney transplant within 6 months.
* Recent acute kidney injury.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/09/2022
Sample size
Target
Accrual to date
Final
1480
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigative Site 5101 - Gosford
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment outside Australia
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United States of America
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California
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Colorado
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Coventry
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Nottingham
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Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tricida, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03710291