Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis
NCT ID: NCT03710291
Last Updated: 2022-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
1480 participants
INTERVENTIONAL
2018-11-20
2022-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TRC101
TRC101
Oral, non-absorbed, polymeric hydrochloric acid binder
Placebo
Placebo
Placebo comparator
Interventions
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TRC101
Oral, non-absorbed, polymeric hydrochloric acid binder
Placebo
Placebo comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Serum bicarbonate 12 - 20 mEq/L.
* On maximum tolerated dose of ACE inhibitor and/or ARB.
Exclusion Criteria
* Anticipated dialysis or kidney transplant within 6 months.
* Recent acute kidney injury.
18 Years
85 Years
ALL
No
Sponsors
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Tricida, Inc.
INDUSTRY
Responsible Party
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Locations
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Investigative Site 4136
Azusa, California, United States
Investigative Site 4148
Denver, Colorado, 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 4153
Fort Lauderdale, Florida, United States
Investigative Site 4122
Hollywood, Florida, United States
Investigative Site 4123
Hollywood, Florida, United States
Investigative Site 4104
Miami, Florida, United States
Investigative Site 4130
Miami Lakes, Florida, United States
Investigative Site 4116
Port Charlotte, Florida, United States
Investigative Site 4152
Tampa, Florida, United States
Investigative Site 4127
Augusta, Georgia, United States
Investigative Site 4141
Greenbelt, Maryland, United States
Investigative Site 4155
Kansas City, Missouri, United States
Investigative Site 4108
Greenville, North Carolina, United States
Investigative Site 4106
Kinston, North Carolina, United States
Investigative Site 4107
New Bern, North Carolina, United States
Investigative Site 4124
Bethlehem, Pennsylvania, United States
Investigative Site 4132
Nashville, Tennessee, United States
Investigative Site 1103
Shkodër, , Albania
Investigative Site 1101
Tirana, , Albania
Investigative Site 4402
Buenos Aires, , Argentina
Investigative Site 4410
Corrientes, , Argentina
Investigative Site 4414
Córdoba, , Argentina
Investigative Site 4408
Córdoba, , Argentina
Investigative Site 4405
Mar del Plata, , Argentina
Investigative Site 4409
San Luis, , Argentina
Investigative Site 2803
Yerevan, , Armenia
Investigative Site 2809
Yerevan, , Armenia
Investigative Site 2802
Yerevan, , Armenia
Investigative site 2801
Yerevan, , Armenia
Investigative Site 2805
Yerevan, , Armenia
Investigative Site 2807
Yerevan, , Armenia
Investigative Site 5101
Gosford, , Australia
Investigative Site 1502
Grodno, , Belarus
Investigative Site 3108
Liège, , Belgium
Investigative Site 3103
Liège, , Belgium
Investigative Site 4518
Caxias do Sul, , Brazil
Investigative Site 4516
Curitiba, , Brazil
Investigative Site 4504
Curitiba, , Brazil
Investigative Site 4507
Juiz de Fora, , Brazil
Investigative Site 4517
São Paulo, , Brazil
Investigative Site 4508
São Paulo, , Brazil
Investigative Site 4509
São Paulo, , Brazil
Investigative Site 4506
São Paulo, , Brazil
Investigative Site 4519
São Paulo, , Brazil
Investigative Site 1211
Kozloduy, , Bulgaria
Investigative Site 1213
Montana, , Bulgaria
Investigative Site 1210
Pleven, , Bulgaria
Investigative Site 1205
Rousse, , Bulgaria
Investigative Site 1212
Rousse, , 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, , Bulgaria
Investigative Site 4203
Brampton, , Canada
Investigative Site 4202
Kitchener, , Canada
Investigative Site 4201
London, , Canada
Investigative Site 4204
Québec, , Canada
Investigative Site 4208
Winnipeg, , Canada
Investigative Site 4604
Concepción, , Chile
Investigative Site 4601
Providencia, , Chile
Investigative Site 4602
Temuco, , Chile
Investigative Site 4703
Barranquilla, , Colombia
Investigative Site 4708
Barranquilla, , Colombia
Investigative Site 4712
Barranquilla, , Colombia
Investigative Site 4705
Cali, , Colombia
Investigative Site 4709
Zipaquirá, , Colombia
Investigative Site 2106
Sokolov, , Czechia
Investigative Site 2107
Znojmo, , Czechia
Investigative Site 3209
Boulogne-Billancourt, , France
Investigative Site 3205
Lille, , France
Investigative Site 2201
Batumi, , Georgia
Investigative Site 2202
Kutaisi, , Georgia
Investigative Site 2208
Tbilisi, , Georgia
Investigative Site 2205
Tbilisi, , Georgia
Investigative Site 2211
Tbilisi, , Georgia
Investigative Site 2204
Tbilisi, , Georgia
Investigative Site 2206
Tbilisi, , Georgia
Investigative Site 2207
Tbilisi, , Georgia
Investigative Site 2209
Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Hong Kong, , Hong Kong
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Hong Kong, , Hong Kong
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Hong Kong, , Hong Kong
Investigative Site 6104
Shatin, , Hong Kong
Investigative Site 2311
Baja, , Hungary
Investigative Site 2312
Budapest, , Hungary
Investigative Site 2304
Budapest, , Hungary
Investigative Site 2306
Győr, , Hungary
Investigative Site 2309
Kaposvár, , Hungary
Investigative Site 2310
Kistarcsa, , Hungary
Investigative Site 2316
Nagykanizsa, , Hungary
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, , Israel
Investigative Site 3408
Genova, , Italy
Investigative Site 3407
Messina, , Italy
Investigative Site 3405
Milan, , Italy
Investigative Site 3406
Napoli, , Italy
Investigative Site 3402
Pavia, , Italy
Investigative Site 3409
Reggio Calabria, , Italy
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, , Malaysia
Investigative Site 4307
Cuernavaca, , Mexico
Investigative Site 4313
Guadalajara, , Mexico
Investigative Site 4304
Guadalajara, , Mexico
Investigative Site 4319
Guadalajara, , Mexico
Investigative Site 4325
Mexico City, , Mexico
Investigative Site 4311
Mexico City, , Mexico
Investigative Site 4302
Mexico City, , Mexico
Investigative Site 4316
Mérida, , Mexico
Investigative Site 4301
Mérida, , 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, , Mexico
Investigative Site 3507
Alkmaar, , Netherlands
Investigative Site 3505
Amersfoort, , Netherlands
Investigative Site 3503
Groningen, , Netherlands
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, , North Macedonia
Investigative Site 2421
Krakow, , Poland
Investigative Site 2414
Warsaw, , Poland
Investigative Site 2412
Zabrze, , Poland
Investigative Site 3604
Aveiro, , Portugal
Investigative Site 3603
Lisbon, , Portugal
Investigative Site 3607
Lisbon, , Portugal
Investigative Site 3605
Vila Nova de Gaia, , Portugal
Investigative Site 1412
Oradea, , Romania
Investigative Site 2501
Belgrade, , Serbia
Investigative Site 2508
Kragujevac, , Serbia
Investigative Site 2510
Kruševac, , Serbia
Investigative Site 2505
Niš, , Serbia
Investigative Site 2514
Užice, , Serbia
Investigative Site 2503
Vršac, , Serbia
Investigative Site 2511
Zaječar, , Serbia
Investigative Site 6401
Singapore, , Singapore
Investigative Site 6403
Singapore, , Singapore
Investigative Site 6404
Singapore, , Singapore
Investigative Site 2604
Košice, , Slovakia
Investigative Site 2606
Košice, , Slovakia
Investigative Site 2603
Svidník, , Slovakia
Investigative Site 5207
Ansan, , South Korea
Investigative Site 5203
Anyang, , South Korea
Investigative Site 5218
Cheonan, , South Korea
Investigative Site 5204
Daejeon, , South Korea
Investigative Site 5205
Goyang, , South Korea
Investigative Site 5215
Guri-si, , South Korea
Investigative Site 5213
Seoul, , South Korea
Investigative Site 5208
Seoul, , South Korea
Investigative Site 5212
Wŏnju, , South Korea
Investigative Site 3716
Barcelona, , Spain
Investigative Site 3707
Barcelona, , Spain
Investigative Site 3706
Barcelona, , Spain
Investigative Site 6512
Changhua, , Taiwan
Investigative Site 6502
Hualien City, , Taiwan
Investigative Site 6501
Kaohsiung City, , Taiwan
Investigative Site 6504
New Taipei City, , Taiwan
Investigative Site 6506
Taichung, , Taiwan
Investigative Site 6510
Taichung, , Taiwan
Investigative Site 6507
Taichung, , Taiwan
Investigative Site 6503
Tainan City, , Taiwan
Investigative Site 6509
Taipei, , Taiwan
Investigative Site 6511
Taipei, , Taiwan
Investigative Site 2712
Dnipro, , Ukraine
Investigative Site 2714
Ivano-Frankivsk, , Ukraine
Investigative Site 2717
Kharkiv, , Ukraine
Investigative Site 2713
Kharkiv, , Ukraine
Investigative Site 2721
Kharkiv, , Ukraine
Investigative Site 2704
Kharkiv, , Ukraine
Investigative Site 2707
Kharkiv, , Ukraine
Investigative Site 2706
Kyiv, , Ukraine
Investigative Site 2703
Kyiv, , Ukraine
Investigative Site 2709
Kyiv, , Ukraine
Investigative Site 2705
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, , Ukraine
Investigative Site 3815
Coventry, , United Kingdom
Investigative Site 3804
Nottingham, , United Kingdom
Investigative Site 3801
Swansea, , United Kingdom
Countries
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References
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Tangri N, Mathur VS, Bushinsky DA, Klaerner G, Li E, Parsell D, Stasiv Y, Walker M, Wesson DE, Wheeler DC, Perkovic V, Inker LA. VALOR-CKD: A Multicenter, Randomized, Double-Blind Placebo-Controlled Trial Evaluating Veverimer in Slowing Progression of CKD in Patients with Metabolic Acidosis. J Am Soc Nephrol. 2024 Mar 1;35(3):311-320. doi: 10.1681/ASN.0000000000000292. Epub 2024 Jan 23.
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.
Other Identifiers
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2018-001303-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TRCA-303
Identifier Type: -
Identifier Source: org_study_id
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