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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03710291
Other study ID # TRCA-303
Secondary ID 2018-001303-36
Status Terminated
Phase Phase 3
First received
Last updated
Start date November 20, 2018
Est. completion date September 27, 2022

Study information

Verified date October 2022
Source Tricida, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1480
Est. completion date September 27, 2022
Est. primary completion date August 23, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Intervention

Drug:
TRC101
Oral, non-absorbed, polymeric hydrochloric acid binder
Placebo
Placebo comparator

Locations

Country Name City State
Albania Investigative Site 1103 Shkodër
Albania Investigative Site 1101 Tirana
Argentina Investigative Site 4402 Buenos Aires
Argentina Investigative Site 4408 Córdoba
Argentina Investigative Site 4414 Córdoba
Argentina Investigative Site 4410 Corrientes
Argentina Investigative Site 4405 Mar Del Plata
Argentina Investigative Site 4409 San Luis
Armenia Investigative site 2801 Yerevan
Armenia Investigative Site 2802 Yerevan
Armenia Investigative Site 2803 Yerevan
Armenia Investigative Site 2805 Yerevan
Armenia Investigative Site 2807 Yerevan
Armenia Investigative Site 2809 Yerevan
Australia Investigative Site 5101 Gosford
Belarus Investigative Site 1502 Grodno
Belgium Investigative Site 3103 Liège
Belgium Investigative Site 3108 Liège
Brazil Investigative Site 4518 Caxias Do Sul
Brazil Investigative Site 4504 Curitiba
Brazil Investigative Site 4516 Curitiba
Brazil Investigative Site 4507 Juiz De Fora
Brazil Investigative Site 4506 São Paulo
Brazil Investigative Site 4508 São Paulo
Brazil Investigative Site 4509 São Paulo
Brazil Investigative Site 4517 São Paulo
Brazil Investigative Site 4519 São Paulo
Bulgaria Investigative Site 1211 Kozloduy
Bulgaria Investigative Site 1213 Montana
Bulgaria Investigative Site 1210 Pleven
Bulgaria Investigative Site 1205 Ruse
Bulgaria Investigative Site 1212 Ruse
Bulgaria Investigative Site 1206 Sevlievo
Bulgaria Investigative Site 1204 Sliven
Bulgaria Investigative Site 1201 Sofia
Bulgaria Investigative Site 1208 Veliko Tarnovo
Bulgaria Investigative Site 1203 Yambol
Canada Investigative Site 4203 Brampton
Canada Investigative Site 4202 Kitchener
Canada Investigative Site 4201 London
Canada Investigative Site 4204 Québec
Canada Investigative Site 4208 Winnipeg
Chile Investigative Site 4604 Concepción
Chile Investigative Site 4601 Providencia
Chile Investigative Site 4602 Temuco
Colombia Investigative Site 4703 Barranquilla
Colombia Investigative Site 4708 Barranquilla
Colombia Investigative Site 4712 Barranquilla
Colombia Investigative Site 4705 Cali
Colombia Investigative Site 4709 Zipaquirá
Czechia Investigative Site 2106 Sokolov
Czechia Investigative Site 2107 Znojmo
France Investigative Site 3209 Boulogne-Billancourt
France Investigative Site 3205 Lille
Georgia Investigative Site 2201 Batumi
Georgia Investigative Site 2202 Kutaisi
Georgia Investigative Site 2204 Tbilisi
Georgia Investigative Site 2205 Tbilisi
Georgia Investigative Site 2206 Tbilisi
Georgia Investigative Site 2207 Tbilisi
Georgia Investigative Site 2208 Tbilisi
Georgia Investigative Site 2209 Tbilisi
Georgia Investigative Site 2210 Tbilisi
Georgia Investigative Site 2211 Tbilisi
Georgia Investigative Site 2212 Tbilisi
Georgia Investigative Site 2213 Tbilisi
Georgia Investigative Site 2214 Tbilisi
Hong Kong Investigative Site 6101 Hong Kong
Hong Kong Investigative Site 6103 Hong Kong
Hong Kong Investigative Site 6105 Hong Kong
Hong Kong Investigative Site 6104 Sha Tin
Hungary Investigative Site 2311 Baja
Hungary Investigative Site 2304 Budapest
Hungary Investigative Site 2312 Budapest
Hungary Investigative Site 2306 Gyor
Hungary Investigative Site 2309 Kaposvár
Hungary Investigative Site 2310 Kistarcsa
Hungary Investigative Site 2316 Nagykanizsa
Israel Investigative Site 3913 Afula
Israel Investigative Site 3902 Ashkelon
Israel Investigative Site 3905 Jerusalem
Israel Investigative Site 3911 Tel Aviv
Israel Investigative Site 3903 Tiberias
Italy Investigative Site 3408 Genova
Italy Investigative Site 3407 Messina
Italy Investigative Site 3405 Milano
Italy Investigative Site 3406 Napoli
Italy Investigative Site 3402 Pavia
Italy Investigative Site 3409 Reggio Calabria
Korea, Republic of Investigative Site 5207 Ansan
Korea, Republic of Investigative Site 5203 Anyang
Korea, Republic of Investigative Site 5218 Cheonan
Korea, Republic of Investigative Site 5204 Daejeon
Korea, Republic of Investigative Site 5205 Goyang
Korea, Republic of Investigative Site 5215 Guri-si
Korea, Republic of Investigative Site 5208 Seoul
Korea, Republic of Investigative Site 5213 Seoul
Korea, Republic of Investigative Site 5212 Wonju
Malaysia Investigative Site 6208 Klang
Malaysia Investigative Site 6203 Kota Bharu
Malaysia Investigative Site 6207 Kota Bharu
Malaysia Investigative Site 6202 Kuala Lumpur
Malaysia Investigative Site 6204 Kuantan
Malaysia Investigative Site 6205 Kulim
Malaysia Investigative Site 6210 Pulau Pinang
Malaysia Investigative Site 6206 Seri Manjung
Malaysia Investigative Site 6201 Sungai Petani
Mexico Investigative Site 4307 Cuernavaca
Mexico Investigative Site 4304 Guadalajara
Mexico Investigative Site 4313 Guadalajara
Mexico Investigative Site 4319 Guadalajara
Mexico Investigative Site 4301 Mérida
Mexico Investigative Site 4316 Mérida
Mexico Investigative Site 4302 Mexico City
Mexico Investigative Site 4311 Mexico City
Mexico Investigative Site 4325 Mexico City
Mexico Investigative Site 4320 Monterrey
Mexico Investigative Site 4315 Morelia
Mexico Investigative Site 4324 Morelia
Mexico Investigative Site 4310 Veracruz
Mexico Investigative Site 4305 Xalapa
Mexico Investigative Site 4312 Zapopan
Netherlands Investigative Site 3507 Alkmaar
Netherlands Investigative Site 3505 Amersfoort
Netherlands Investigative Site 3503 Groningen
North Macedonia Investigative Site 1304 Bitola
North Macedonia Investigative Site 1305 Shtip
North Macedonia Investigative Site 1301 Skopje
North Macedonia Investigative Site 1303 Skopje
North Macedonia Investigative Site 1302 Struga
Poland Investigative Site 2421 Kraków
Poland Investigative Site 2414 Warsaw
Poland Investigative Site 2412 Zabrze
Portugal Investigative Site 3604 Aveiro
Portugal Investigative Site 3603 Lisboa
Portugal Investigative Site 3607 Lisboa
Portugal Investigative Site 3605 Vila Nova De Gaia
Romania Investigative Site 1412 Oradea
Serbia Investigative Site 2501 Belgrade
Serbia Investigative Site 2508 Kragujevac
Serbia Investigative Site 2510 Krusevac
Serbia Investigative Site 2505 Niš
Serbia Investigative Site 2514 Užice
Serbia Investigative Site 2503 Vršac
Serbia Investigative Site 2511 Zajecar
Singapore Investigative Site 6401 Singapore
Singapore Investigative Site 6403 Singapore
Singapore Investigative Site 6404 Singapore
Slovakia Investigative Site 2604 Košice
Slovakia Investigative Site 2606 Košice
Slovakia Investigative Site 2603 Svidník
Spain Investigative Site 3706 Barcelona
Spain Investigative Site 3707 Barcelona
Spain Investigative Site 3716 Barcelona
Taiwan Investigative Site 6512 Changhua
Taiwan Investigative Site 6502 Hualien City
Taiwan Investigative Site 6501 Kaohsiung
Taiwan Investigative Site 6504 New Taipei City
Taiwan Investigative Site 6506 Taichung
Taiwan Investigative Site 6507 Taichung
Taiwan Investigative Site 6510 Taichung
Taiwan Investigative Site 6503 Tainan
Taiwan Investigative Site 6509 Taipei
Taiwan Investigative Site 6511 Taipei
Ukraine Investigative Site 2712 Dnipro
Ukraine Investigative Site 2714 Ivano-Frankivs'k
Ukraine Investigative Site 2704 Kharkiv
Ukraine Investigative Site 2707 Kharkiv
Ukraine Investigative Site 2713 Kharkiv
Ukraine Investigative Site 2717 Kharkiv
Ukraine Investigative Site 2721 Kharkiv
Ukraine Investigative Site 2703 Kyiv
Ukraine Investigative Site 2705 Kyiv
Ukraine Investigative Site 2706 Kyiv
Ukraine Investigative Site 2709 Kyiv
Ukraine Investigative Site 2710 Kyiv
Ukraine Investigative Site 2716 Kyiv
Ukraine Investigative Site 2718 Ternopil'
Ukraine Investigative Site 2719 Zaporizhzhya
Ukraine Investigative Site 2715 Zhytomyr
United Kingdom Investigative Site 3815 Coventry
United Kingdom Investigative Site 3804 Nottingham
United Kingdom Investigative Site 3801 Swansea
United States Investigative Site 4127 Augusta Georgia
United States Investigative Site 4136 Azusa California
United States Investigative Site 4124 Bethlehem Pennsylvania
United States Investigative Site 4157 Boca Raton Florida
United States Investigative Site 4146 Bradenton Florida
United States Investigative Site 4102 Coral Springs Florida
United States Investigative Site 4148 Denver Colorado
United States Investigative Site 4153 Fort Lauderdale Florida
United States Investigative Site 4141 Greenbelt Maryland
United States Investigative Site 4108 Greenville North Carolina
United States Investigative Site 4122 Hollywood Florida
United States Investigative Site 4123 Hollywood Florida
United States Investigative Site 4155 Kansas City Missouri
United States Investigative Site 4106 Kinston North Carolina
United States Investigative Site 4104 Miami Florida
United States Investigative Site 4130 Miami Lakes Florida
United States Investigative Site 4132 Nashville Tennessee
United States Investigative Site 4107 New Bern North Carolina
United States Investigative Site 4116 Port Charlotte Florida
United States Investigative Site 4152 Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Tricida, Inc.

Countries where clinical trial is conducted

United States,  Albania,  Argentina,  Armenia,  Australia,  Belarus,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Czechia,  France,  Georgia,  Hong Kong,  Hungary,  Israel,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  North Macedonia,  Poland,  Portugal,  Romania,  Serbia,  Singapore,  Slovakia,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety of TRC101 Frequency, intensity, and relationship to study drug of adverse events and serious adverse events. Through study completion, up to approximately 6 years.
Primary Progression of chronic kidney disease Time to first occurrence of: a confirmed =40% reduction in eGFR; ESRD; renal death. Through study completion, up to approximately 6 years.
Secondary Death (all-cause), ESRD or a confirmed =50% reduction in eGFR Time to first occurrence of: death (all-cause); ESRD; a confirmed =50% reduction in eGFR. Through study completion, up to approximately 6 years.
Secondary Physical functioning (subjective) Kidney Disease Quality of Life Physical Functioning Survey. 18 months after randomization.
Secondary Physical functioning (objective) Repeated chair stand test. 18 months after randomization.
Secondary ESRD or renal death Time to ESRD or renal death. Through study completion, up to approximately 6 years.
Secondary Primary outcome measure OR cardiovascular death Time to first occurrence of: a confirmed =40% reduction in eGFR; ESRD; renal death; cardiovascular death. Through study completion, up to approximately 6 years.
Secondary Serum creatinine Time to first occurrence of a confirmed doubling of serum creatinine. Through study completion, up to approximately 6 years.
Secondary =50% reduction in eGFR Time to first occurrence of a confirmed =50% reduction in eGFR. Through study completion, up to approximately 6 years.
Secondary =40% reduction in eGFR Time to first occurrence of a confirmed =40% reduction in eGFR. Through study completion, up to approximately 6 years.
Secondary All-cause hospitalization Frequency of all-cause hospitalization. Through study completion, up to approximately 6 years.
Secondary Cardiovascular death Time to cardiovascular death. Through study completion, up to approximately 6 years.
Secondary All-cause mortality Time to all-cause mortality. Through study completion, up to approximately 6 years.
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