Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
14/10/2022

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
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
Albania
State/province [10] 0 0
Shkodër
Country [11] 0 0
Albania
State/province [11] 0 0
Tirana
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Corrientes
Country [14] 0 0
Argentina
State/province [14] 0 0
Córdoba
Country [15] 0 0
Argentina
State/province [15] 0 0
Mar Del Plata
Country [16] 0 0
Argentina
State/province [16] 0 0
San Luis
Country [17] 0 0
Armenia
State/province [17] 0 0
Yerevan
Country [18] 0 0
Belarus
State/province [18] 0 0
Grodno
Country [19] 0 0
Belgium
State/province [19] 0 0
Liège
Country [20] 0 0
Brazil
State/province [20] 0 0
Caxias Do Sul
Country [21] 0 0
Brazil
State/province [21] 0 0
Curitiba
Country [22] 0 0
Brazil
State/province [22] 0 0
Juiz De Fora
Country [23] 0 0
Brazil
State/province [23] 0 0
São Paulo
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Kozloduy
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Montana
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Pleven
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Ruse
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Sevlievo
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Sliven
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Sofia
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Veliko Tarnovo
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Yambol
Country [33] 0 0
Canada
State/province [33] 0 0
Brampton
Country [34] 0 0
Canada
State/province [34] 0 0
Kitchener
Country [35] 0 0
Canada
State/province [35] 0 0
London
Country [36] 0 0
Canada
State/province [36] 0 0
Québec
Country [37] 0 0
Canada
State/province [37] 0 0
Winnipeg
Country [38] 0 0
Chile
State/province [38] 0 0
Concepción
Country [39] 0 0
Chile
State/province [39] 0 0
Providencia
Country [40] 0 0
Chile
State/province [40] 0 0
Temuco
Country [41] 0 0
Colombia
State/province [41] 0 0
Barranquilla
Country [42] 0 0
Colombia
State/province [42] 0 0
Cali
Country [43] 0 0
Colombia
State/province [43] 0 0
Zipaquirá
Country [44] 0 0
Czechia
State/province [44] 0 0
Sokolov
Country [45] 0 0
Czechia
State/province [45] 0 0
Znojmo
Country [46] 0 0
France
State/province [46] 0 0
Boulogne-Billancourt
Country [47] 0 0
France
State/province [47] 0 0
Lille
Country [48] 0 0
Georgia
State/province [48] 0 0
Batumi
Country [49] 0 0
Georgia
State/province [49] 0 0
Kutaisi
Country [50] 0 0
Georgia
State/province [50] 0 0
Tbilisi
Country [51] 0 0
Hong Kong
State/province [51] 0 0
Hong Kong
Country [52] 0 0
Hong Kong
State/province [52] 0 0
Sha Tin
Country [53] 0 0
Hungary
State/province [53] 0 0
Baja
Country [54] 0 0
Hungary
State/province [54] 0 0
Budapest
Country [55] 0 0
Hungary
State/province [55] 0 0
Gyor
Country [56] 0 0
Hungary
State/province [56] 0 0
Kaposvár
Country [57] 0 0
Hungary
State/province [57] 0 0
Kistarcsa
Country [58] 0 0
Hungary
State/province [58] 0 0
Nagykanizsa
Country [59] 0 0
Israel
State/province [59] 0 0
Afula
Country [60] 0 0
Israel
State/province [60] 0 0
Ashkelon
Country [61] 0 0
Israel
State/province [61] 0 0
Jerusalem
Country [62] 0 0
Israel
State/province [62] 0 0
Tel Aviv
Country [63] 0 0
Israel
State/province [63] 0 0
Tiberias
Country [64] 0 0
Italy
State/province [64] 0 0
Genova
Country [65] 0 0
Italy
State/province [65] 0 0
Messina
Country [66] 0 0
Italy
State/province [66] 0 0
Milano
Country [67] 0 0
Italy
State/province [67] 0 0
Napoli
Country [68] 0 0
Italy
State/province [68] 0 0
Pavia
Country [69] 0 0
Italy
State/province [69] 0 0
Reggio Calabria
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Ansan
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Anyang
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Cheonan
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Daejeon
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Goyang
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Guri-si
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Seoul
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Wonju
Country [78] 0 0
Malaysia
State/province [78] 0 0
Klang
Country [79] 0 0
Malaysia
State/province [79] 0 0
Kota Bharu
Country [80] 0 0
Malaysia
State/province [80] 0 0
Kuala Lumpur
Country [81] 0 0
Malaysia
State/province [81] 0 0
Kuantan
Country [82] 0 0
Malaysia
State/province [82] 0 0
Kulim
Country [83] 0 0
Malaysia
State/province [83] 0 0
Pulau Pinang
Country [84] 0 0
Malaysia
State/province [84] 0 0
Seri Manjung
Country [85] 0 0
Malaysia
State/province [85] 0 0
Sungai Petani
Country [86] 0 0
Mexico
State/province [86] 0 0
Cuernavaca
Country [87] 0 0
Mexico
State/province [87] 0 0
Guadalajara
Country [88] 0 0
Mexico
State/province [88] 0 0
Mexico City
Country [89] 0 0
Mexico
State/province [89] 0 0
Monterrey
Country [90] 0 0
Mexico
State/province [90] 0 0
Morelia
Country [91] 0 0
Mexico
State/province [91] 0 0
Mérida
Country [92] 0 0
Mexico
State/province [92] 0 0
Veracruz
Country [93] 0 0
Mexico
State/province [93] 0 0
Xalapa
Country [94] 0 0
Mexico
State/province [94] 0 0
Zapopan
Country [95] 0 0
Netherlands
State/province [95] 0 0
Alkmaar
Country [96] 0 0
Netherlands
State/province [96] 0 0
Amersfoort
Country [97] 0 0
Netherlands
State/province [97] 0 0
Groningen
Country [98] 0 0
North Macedonia
State/province [98] 0 0
Bitola
Country [99] 0 0
North Macedonia
State/province [99] 0 0
Shtip
Country [100] 0 0
North Macedonia
State/province [100] 0 0
Skopje
Country [101] 0 0
North Macedonia
State/province [101] 0 0
Struga
Country [102] 0 0
Poland
State/province [102] 0 0
Kraków
Country [103] 0 0
Poland
State/province [103] 0 0
Warsaw
Country [104] 0 0
Poland
State/province [104] 0 0
Zabrze
Country [105] 0 0
Portugal
State/province [105] 0 0
Aveiro
Country [106] 0 0
Portugal
State/province [106] 0 0
Lisboa
Country [107] 0 0
Portugal
State/province [107] 0 0
Vila Nova De Gaia
Country [108] 0 0
Romania
State/province [108] 0 0
Oradea
Country [109] 0 0
Serbia
State/province [109] 0 0
Belgrade
Country [110] 0 0
Serbia
State/province [110] 0 0
Kragujevac
Country [111] 0 0
Serbia
State/province [111] 0 0
Krusevac
Country [112] 0 0
Serbia
State/province [112] 0 0
Niš
Country [113] 0 0
Serbia
State/province [113] 0 0
Užice
Country [114] 0 0
Serbia
State/province [114] 0 0
Vršac
Country [115] 0 0
Serbia
State/province [115] 0 0
Zajecar
Country [116] 0 0
Singapore
State/province [116] 0 0
Singapore
Country [117] 0 0
Slovakia
State/province [117] 0 0
Košice
Country [118] 0 0
Slovakia
State/province [118] 0 0
Svidník
Country [119] 0 0
Spain
State/province [119] 0 0
Barcelona
Country [120] 0 0
Taiwan
State/province [120] 0 0
Changhua
Country [121] 0 0
Taiwan
State/province [121] 0 0
Hualien City
Country [122] 0 0
Taiwan
State/province [122] 0 0
Kaohsiung
Country [123] 0 0
Taiwan
State/province [123] 0 0
New Taipei City
Country [124] 0 0
Taiwan
State/province [124] 0 0
Taichung
Country [125] 0 0
Taiwan
State/province [125] 0 0
Tainan
Country [126] 0 0
Taiwan
State/province [126] 0 0
Taipei
Country [127] 0 0
Ukraine
State/province [127] 0 0
Dnipro
Country [128] 0 0
Ukraine
State/province [128] 0 0
Ivano-Frankivs'k
Country [129] 0 0
Ukraine
State/province [129] 0 0
Kharkiv
Country [130] 0 0
Ukraine
State/province [130] 0 0
Kyiv
Country [131] 0 0
Ukraine
State/province [131] 0 0
Ternopil'
Country [132] 0 0
Ukraine
State/province [132] 0 0
Zaporizhzhya
Country [133] 0 0
Ukraine
State/province [133] 0 0
Zhytomyr
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Coventry
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Nottingham
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Swansea

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/study/NCT03710291
Trial related presentations / publications
Hultin S, Johnson DW, Badve SV. Recent evidence on the effect of treatment of metabolic acid on the progression of kidney disease. Curr Opin Nephrol Hypertens. 2021 Sep 1;30(5):467-473. doi: 10.1097/MNH.0000000000000728.
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



Summary Results

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