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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03710291
Ethics application status
Date submitted
11/10/2018
Date registered
18/10/2018
Date last updated
25/07/2019

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. - Time to first occurrence of: a confirmed =40% reduction in eGFR; ESRD; renal death.
Timepoint [1] 0 0
Through study completion, on average 3.5 years.
Secondary outcome [1] 0 0
Time to ESRD. - Time to either chronic dialysis or kidney transplant.
Timepoint [1] 0 0
Through study completion, on average 3.5 years.
Secondary outcome [2] 0 0
eGFR slope. - Change in eGFR over time.
Timepoint [2] 0 0
Through study completion, on average 3.5 years.
Secondary outcome [3] 0 0
KDQOL. - Kidney Disease Quality of Life Physical Functioning Survey.
Timepoint [3] 0 0
Through study completion, on average 3.5 years.
Secondary outcome [4] 0 0
CKD progression or cardiovascular death - Time to first occurrence of: a confirmed =40% reduction in eGFR; ESRD; renal death; or cardiovascular death.
Timepoint [4] 0 0
Through study completion, on average 3.5 years.
Secondary outcome [5] 0 0
All-cause hospitalization. - Hospitalization or >24 hours emergency department stay.
Timepoint [5] 0 0
Through study completion, on average 3.5 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
Gender
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
Recruiting
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)
Recruitment hospital [1] 0 0
Investigative Site 5110 - Benowa
Recruitment hospital [2] 0 0
Investigative Site 5107 - Fitzroy
Recruitment hospital [3] 0 0
Investigative Site 5101 - Gosford
Recruitment hospital [4] 0 0
Investigative Site 5106 - New Lambton Heights
Recruitment hospital [5] 0 0
Investigative Site 5102 - Parkville
Recruitment postcode(s) [1] 0 0
4217 - Benowa
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Tricida, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic
kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with
metabolic acidosis.
Trial website
https://clinicaltrials.gov/show/NCT03710291
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
Yuri Stasiv, PhD
Address 0 0
Country 0 0
Phone 0 0
415-988-5120
Fax 0 0
Email 0 0
ystasiv@tricida.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03710291