Clinical trial NCT03710291: Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Metabolic Acidosis
Chronic Kidney Disease
Keywords: serum bicarbonate
renal outcomes
TRC101
eGFR
veverimer
Lead sponsor: Tricida, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-18
Enrollment: 1480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a randomized, double-blind, placebo-controlled trial. Eligible subjects will be randomized in a 1:1 ratio to TRC101 or placebo. The primary endpoint of the study will be progression of renal disease, defined by time to first occurrence of any event in the composite endpoint consisting of a confirmed ≥ 40% reduction in eGFR, end-stage renal disease (ESRD), and renal death. The study will terminate when the independent blinded Clinical Endpoint Adjudication Committee has positively adjudicated the targeted number of primary efficacy endpoint events. The maximum duration of follow-up for a randomized subject is anticipated to be approximately 6 years.

Eligibility criteria: 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.

Exclusion Criteria:

* Acute metabolic acidosis.
* Anticipated dialysis or kidney transplant within 6 months.
* Recent acute kidney injury.

Primary outcomes:
measure: Progression of chronic kidney disease
timeFrame: Through study completion, up to approximately 6 years.
Secondary outcomes:
measure: Death (all-cause), ESRD or a confirmed ≥50% reduction in eGFR
timeFrame: Through study completion, up to approximately 6 years.
measure: Physical functioning (subjective)
timeFrame: 18 months after randomization.
measure: Physical functioning (objective)
timeFrame: 18 months after randomization.
measure: ESRD or renal death
timeFrame: Through study completion, up to approximately 6 years.
measure: Primary outcome measure OR cardiovascular death
timeFrame: Through study completion, up to approximately 6 years.
measure: Serum creatinine
timeFrame: Through study completion, up to approximately 6 years.
measure: ≥50% reduction in eGFR
timeFrame: Through study completion, up to approximately 6 years.
measure: ≥40% reduction in eGFR
timeFrame: Through study completion, up to approximately 6 years.
measure: All-cause hospitalization
timeFrame: Through study completion, up to approximately 6 years.
measure: Cardiovascular death
timeFrame: Through study completion, up to approximately 6 years.
measure: All-cause mortality
timeFrame: Through study completion, up to approximately 6 years.
Other outcomes:
measure: Safety of TRC101
timeFrame: Through study completion, up to approximately 6 years.
Locations:
city: Azusa
country: United States
facility: Investigative Site 4136
state: California
city: Denver
country: United States
facility: Investigative Site 4148
state: Colorado
city: Boca Raton
country: United States
facility: Investigative Site 4157
state: Florida
city: Bradenton
country: United States
facility: Investigative Site 4146
state: Florida
city: Coral Springs
country: United States
facility: Investigative Site 4102
state: Florida
city: Fort Lauderdale
country: United States
facility: Investigative Site 4153
state: Florida
city: Hollywood
country: United States
facility: Investigative Site 4122
state: Florida
city: Hollywood
country: United States
facility: Investigative Site 4123
state: Florida
city: Miami Lakes
country: United States
facility: Investigative Site 4130
state: Florida
city: Miami
country: United States
facility: Investigative Site 4104
state: Florida
city: Port Charlotte
country: United States
facility: Investigative Site 4116
state: Florida
city: Tampa
country: United States
facility: Investigative Site 4152
state: Florida
city: Augusta
country: United States
facility: Investigative Site 4127
state: Georgia
city: Greenbelt
country: United States
facility: Investigative Site 4141
state: Maryland
city: Kansas City
country: United States
facility: Investigative Site 4155
state: Missouri
city: Greenville
country: United States
facility: Investigative Site 4108
state: North Carolina
city: Kinston
country: United States
facility: Investigative Site 4106
state: North Carolina
city: New Bern
country: United States
facility: Investigative Site 4107
state: North Carolina
city: Bethlehem
country: United States
facility: Investigative Site 4124
state: Pennsylvania
city: Nashville
country: United States
facility: Investigative Site 4132
state: Tennessee
city: Shkodër
country: Albania
facility: Investigative Site 1103
city: Tirana
country: Albania
facility: Investigative Site 1101
city: Buenos Aires
country: Argentina
facility: Investigative Site 4402
city: Corrientes
country: Argentina
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city: Córdoba
country: Argentina
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city: Córdoba
country: Argentina
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city: Mar Del Plata
country: Argentina
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city: San Luis
country: Argentina
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city: Yerevan
country: Armenia
facility: Investigative Site 2803
city: Yerevan
country: Armenia
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city: Yerevan
country: Armenia
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city: Yerevan
country: Armenia
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country: Australia
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country: Belarus
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country: Belgium
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city: Liège
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country: Brazil
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city: Curitiba
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country: Bulgaria
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country: Bulgaria
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city: Ruse
country: Bulgaria
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city: Ruse
country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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city: Veliko Tarnovo
country: Bulgaria
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city: Yambol
country: Bulgaria
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city: Brampton
country: Canada
facility: Investigative Site 4203
city: Kitchener
country: Canada
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city: London
country: Canada
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country: Canada
facility: Investigative Site 4204
city: Winnipeg
country: Canada
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country: Chile
facility: Investigative Site 4604
city: Providencia
country: Chile
facility: Investigative Site 4601
city: Temuco
country: Chile
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country: Colombia
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city: Barranquilla
country: Colombia
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city: Barranquilla
country: Colombia
facility: Investigative Site 4712
city: Cali
country: Colombia
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city: Zipaquirá
country: Colombia
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city: Sokolov
country: Czechia
facility: Investigative Site 2106
city: Znojmo
country: Czechia
facility: Investigative Site 2107
city: Boulogne-Billancourt
country: France
facility: Investigative Site 3209
city: Lille
country: France
facility: Investigative Site 3205
city: Batumi
country: Georgia
facility: Investigative Site 2201
city: Kutaisi
country: Georgia
facility: Investigative Site 2202
city: Tbilisi
country: Georgia
facility: Investigative Site 2208
city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
facility: Investigative Site 2211
city: Tbilisi
country: Georgia
facility: Investigative Site 2204
city: Tbilisi
country: Georgia
facility: Investigative Site 2206
city: Tbilisi
country: Georgia
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city: Tbilisi
country: Georgia
facility: Investigative Site 2209
city: Tbilisi
country: Georgia
facility: Investigative Site 2212
city: Tbilisi
country: Georgia
facility: Investigative Site 2213
city: Tbilisi
country: Georgia
facility: Investigative Site 2214
city: Tbilisi
country: Georgia
facility: Investigative Site 2210
city: Hong Kong
country: Hong Kong
facility: Investigative Site 6101
city: Hong Kong
country: Hong Kong
facility: Investigative Site 6103
city: Hong Kong
country: Hong Kong
facility: Investigative Site 6105
city: Sha Tin
country: Hong Kong
facility: Investigative Site 6104
city: Baja
country: Hungary
facility: Investigative Site 2311
city: Budapest
country: Hungary
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city: Budapest
country: Hungary
facility: Investigative Site 2304
city: Győr
country: Hungary
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city: Kaposvár
country: Hungary
facility: Investigative Site 2309
city: Kistarcsa
country: Hungary
facility: Investigative Site 2310
city: Nagykanizsa
country: Hungary
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city: Afula
country: Israel
facility: Investigative Site 3913
city: Ashkelon
country: Israel
facility: Investigative Site 3902
city: Jerusalem
country: Israel
facility: Investigative Site 3905
city: Tel Aviv
country: Israel
facility: Investigative Site 3911
city: Tiberias
country: Israel
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city: Genova
country: Italy
facility: Investigative Site 3408
city: Messina
country: Italy
facility: Investigative Site 3407
city: Milano
country: Italy
facility: Investigative Site 3405
city: Napoli
country: Italy
facility: Investigative Site 3406
city: Pavia
country: Italy
facility: Investigative Site 3402
city: Reggio Calabria
country: Italy
facility: Investigative Site 3409
city: Ansan
country: Korea, Republic of
facility: Investigative Site 5207
city: Anyang
country: Korea, Republic of
facility: Investigative Site 5203
city: Cheonan
country: Korea, Republic of
facility: Investigative Site 5218
city: Daejeon
country: Korea, Republic of
facility: Investigative Site 5204
city: Goyang
country: Korea, Republic of
facility: Investigative Site 5205
city: Guri-si
country: Korea, Republic of
facility: Investigative Site 5215
city: Seoul
country: Korea, Republic of
facility: Investigative Site 5213
city: Seoul
country: Korea, Republic of
facility: Investigative Site 5208
city: Wŏnju
country: Korea, Republic of
facility: Investigative Site 5212
city: Klang
country: Malaysia
facility: Investigative Site 6208
city: Kota Bharu
country: Malaysia
facility: Investigative Site 6203
city: Kota Bharu
country: Malaysia
facility: Investigative Site 6207
city: Kuala Lumpur
country: Malaysia
facility: Investigative Site 6202
city: Kuantan
country: Malaysia
facility: Investigative Site 6204
city: Kulim
country: Malaysia
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city: Pulau Pinang
country: Malaysia
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city: Seri Manjung
country: Malaysia
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city: Sungai Petani
country: Malaysia
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city: Cuernavaca
country: Mexico
facility: Investigative Site 4307
city: Guadalajara
country: Mexico
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city: Guadalajara
country: Mexico
facility: Investigative Site 4304
city: Guadalajara
country: Mexico
facility: Investigative Site 4319
city: Mexico City
country: Mexico
facility: Investigative Site 4325
city: Mexico City
country: Mexico
facility: Investigative Site 4311
city: Mexico City
country: Mexico
facility: Investigative Site 4302
city: Monterrey
country: Mexico
facility: Investigative Site 4320
city: Morelia
country: Mexico
facility: Investigative Site 4315
city: Morelia
country: Mexico
facility: Investigative Site 4324
city: Mérida
country: Mexico
facility: Investigative Site 4316
city: Mérida
country: Mexico
facility: Investigative Site 4301
city: Veracruz
country: Mexico
facility: Investigative Site 4310
city: Xalapa
country: Mexico
facility: Investigative Site 4305
city: Zapopan
country: Mexico
facility: Investigative Site 4312
city: Alkmaar
country: Netherlands
facility: Investigative Site 3507
city: Amersfoort
country: Netherlands
facility: Investigative Site 3505
city: Groningen
country: Netherlands
facility: Investigative Site 3503
city: Bitola
country: North Macedonia
facility: Investigative Site 1304
city: Shtip
country: North Macedonia
facility: Investigative Site 1305
city: Skopje
country: North Macedonia
facility: Investigative Site 1301
city: Skopje
country: North Macedonia
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city: Struga
country: North Macedonia
facility: Investigative Site 1302
city: Kraków
country: Poland
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city: Warsaw
country: Poland
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city: Zabrze
country: Poland
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city: Aveiro
country: Portugal
facility: Investigative Site 3604
city: Lisboa
country: Portugal
facility: Investigative Site 3603
city: Lisboa
country: Portugal
facility: Investigative Site 3607
city: Vila Nova De Gaia
country: Portugal
facility: Investigative Site 3605
city: Oradea
country: Romania
facility: Investigative Site 1412
city: Belgrade
country: Serbia
facility: Investigative Site 2501
city: Kragujevac
country: Serbia
facility: Investigative Site 2508
city: Krusevac
country: Serbia
facility: Investigative Site 2510
city: Niš
country: Serbia
facility: Investigative Site 2505
city: Užice
country: Serbia
facility: Investigative Site 2514
city: Vršac
country: Serbia
facility: Investigative Site 2503
city: Zaječar
country: Serbia
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city: Singapore
country: Singapore
facility: Investigative Site 6401
city: Singapore
country: Singapore
facility: Investigative Site 6403
city: Singapore
country: Singapore
facility: Investigative Site 6404
city: Košice
country: Slovakia
facility: Investigative Site 2604
city: Košice
country: Slovakia
facility: Investigative Site 2606
city: Svidník
country: Slovakia
facility: Investigative Site 2603
city: Barcelona
country: Spain
facility: Investigative Site 3716
city: Barcelona
country: Spain
facility: Investigative Site 3707
city: Barcelona
country: Spain
facility: Investigative Site 3706
city: Changhua
country: Taiwan
facility: Investigative Site 6512
city: Hualien City
country: Taiwan
facility: Investigative Site 6502
city: Kaohsiung
country: Taiwan
facility: Investigative Site 6501
city: New Taipei City
country: Taiwan
facility: Investigative Site 6504
city: Taichung
country: Taiwan
facility: Investigative Site 6506
city: Taichung
country: Taiwan
facility: Investigative Site 6510
city: Taichung
country: Taiwan
facility: Investigative Site 6507
city: Tainan
country: Taiwan
facility: Investigative Site 6503
city: Taipei
country: Taiwan
facility: Investigative Site 6509
city: Taipei
country: Taiwan
facility: Investigative Site 6511
city: Dnipro
country: Ukraine
facility: Investigative Site 2712
city: Ivano-Frankivs'k
country: Ukraine
facility: Investigative Site 2714
city: Kharkiv
country: Ukraine
facility: Investigative Site 2717
city: Kharkiv
country: Ukraine
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city: Kharkiv
country: Ukraine
facility: Investigative Site 2721
city: Kharkiv
country: Ukraine
facility: Investigative Site 2704
city: Kharkiv
country: Ukraine
facility: Investigative Site 2707
city: Kyiv
country: Ukraine
facility: Investigative Site 2706
city: Kyiv
country: Ukraine
facility: Investigative Site 2703
city: Kyiv
country: Ukraine
facility: Investigative Site 2709
city: Kyiv
country: Ukraine
facility: Investigative Site 2705
city: Kyiv
country: Ukraine
facility: Investigative Site 2710
city: Kyiv
country: Ukraine
facility: Investigative Site 2716
city: Ternopil'
country: Ukraine
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city: Zaporizhzhya
country: Ukraine
facility: Investigative Site 2719
city: Zhytomyr
country: Ukraine
facility: Investigative Site 2715
city: Coventry
country: United Kingdom
facility: Investigative Site 3815
city: Nottingham
country: United Kingdom
facility: Investigative Site 3804
city: Swansea
country: United Kingdom
facility: Investigative Site 3801
Study officials:
References:
citation: 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.