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Clinical Trial Details

Trial ID: L0601
Source ID: NCT03710291
Associated Drug: Trc101
Title: Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis
Acronym: VALOR-CKD
Status: TERMINATED
Study Results: NO
Results:
Conditions: Metabolic Acidosis|Chronic Kidney Disease
Interventions: DRUG: TRC101|DRUG: Placebo
Outcome Measures: 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.|Physical functioning (subjective), Kidney Disease Quality of Life Physical Functioning Survey., 18 months after randomization.|Physical functioning (objective), Repeated chair stand test., 18 months after randomization.|ESRD or renal death, Time to ESRD or renal death., Through study completion, up to approximately 6 years.|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.|Serum creatinine, Time to first occurrence of a confirmed doubling of serum creatinine., Through study completion, up to approximately 6 years.|≥50% reduction in eGFR, Time to first occurrence of a confirmed ≥50% reduction in eGFR., Through study completion, up to approximately 6 years.|≥40% reduction in eGFR, Time to first occurrence of a confirmed ≥40% reduction in eGFR., Through study completion, up to approximately 6 years.|All-cause hospitalization, Frequency of all-cause hospitalization., Through study completion, up to approximately 6 years.|Cardiovascular death, Time to cardiovascular death., Through study completion, up to approximately 6 years.|All-cause mortality, Time to all-cause mortality., Through study completion, up to approximately 6 years. | 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.
Sponsor/Collaborators: Sponsor: Tricida, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1480
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-11-20
Completion Date: 2022-09-27
Results First Posted:
Last Update Posted: 2022-10-14
Locations: Investigative Site 4136, Azusa, California, 91702, United States|Investigative Site 4148, Denver, Colorado, 80230, United States|Investigative Site 4157, Boca Raton, Florida, 33431, United States|Investigative Site 4146, Bradenton, Florida, 34209, United States|Investigative Site 4102, Coral Springs, Florida, 33071, United States|Investigative Site 4153, Fort Lauderdale, Florida, 33308, United States|Investigative Site 4122, Hollywood, Florida, 33021, United States|Investigative Site 4123, Hollywood, Florida, 33024, United States|Investigative Site 4130, Miami Lakes, Florida, 33014, United States|Investigative Site 4104, Miami, Florida, 33015, United States|Investigative Site 4116, Port Charlotte, Florida, 33952, United States|Investigative Site 4152, Tampa, Florida, 33637, United States|Investigative Site 4127, Augusta, Georgia, 30904, United States|Investigative Site 4141, Greenbelt, Maryland, 20770, United States|Investigative Site 4155, Kansas City, Missouri, 64111, United States|Investigative Site 4108, Greenville, North Carolina, 27834, United States|Investigative Site 4106, Kinston, North Carolina, 28504, United States|Investigative Site 4107, New Bern, North Carolina, 28562, United States|Investigative Site 4124, Bethlehem, Pennsylvania, 18017, United States|Investigative Site 4132, Nashville, Tennessee, 37205, United States|Investigative Site 1103, Shkodër, 4001, Albania|Investigative Site 1101, Tirana, 1023, Albania|Investigative Site 4402, Buenos Aires, B6000GMA, Argentina|Investigative Site 4410, Corrientes, W3400AMZ, Argentina|Investigative Site 4414, Córdoba, X5000AAW, Argentina|Investigative Site 4408, Córdoba, X5002AOQ, Argentina|Investigative Site 4405, Mar Del Plata, B7600FYK, Argentina|Investigative Site 4409, San Luis, D5700CGR, Argentina|Investigative Site 2803, Yerevan, 0014, Armenia|Investigative Site 2809, Yerevan, 0015, Armenia|Investigative Site 2802, Yerevan, 0025, Armenia|Investigative site 2801, Yerevan, 0052, Armenia|Investigative Site 2805, Yerevan, 0075, Armenia|Investigative Site 2807, Yerevan, 0078, Armenia|Investigative Site 5101, Gosford, 2250, Australia|Investigative Site 1502, Grodno, 230017, Belarus|Investigative Site 3108, Liège, 3108, Belgium|Investigative Site 3103, Liège, 4000, Belgium|Investigative Site 4518, Caxias Do Sul, 95010-005, Brazil|Investigative Site 4516, Curitiba, 80060-150, Brazil|Investigative Site 4504, Curitiba, 80440-020, Brazil|Investigative Site 4507, Juiz De Fora, 36036-330, Brazil|Investigative Site 4517, São Paulo, 01323-903, Brazil|Investigative Site 4508, São Paulo, 09090-790, Brazil|Investigative Site 4509, São Paulo, 09715-090, Brazil|Investigative Site 4506, São Paulo, 15090-000, Brazil|Investigative Site 4519, São Paulo, 18618-686, Brazil|Investigative Site 1211, Kozloduy, 3320, Bulgaria|Investigative Site 1213, Montana, 3400, Bulgaria|Investigative Site 1210, Pleven, 5800, Bulgaria|Investigative Site 1205, Ruse, 7000, Bulgaria|Investigative Site 1212, Ruse, 7000, Bulgaria|Investigative Site 1206, Sevlievo, 5400, Bulgaria|Investigative Site 1204, Sliven, 8800, Bulgaria|Investigative Site 1201, Sofia, 1612, Bulgaria|Investigative Site 1208, Veliko Tarnovo, 5000, Bulgaria|Investigative Site 1203, Yambol, 8600, Bulgaria|Investigative Site 4203, Brampton, L6S 0C9, Canada|Investigative Site 4202, Kitchener, N2H 5Z8, Canada|Investigative Site 4201, London, N6A 5A5, Canada|Investigative Site 4204, Québec, G1R 2J6, Canada|Investigative Site 4208, Winnipeg, R2V 3M3, Canada|Investigative Site 4604, Concepción, 4070038, Chile|Investigative Site 4601, Providencia, 7500739, Chile|Investigative Site 4602, Temuco, 4781151, Chile|Investigative Site 4703, Barranquilla, 080020, Colombia|Investigative Site 4708, Barranquilla, 080020, Colombia|Investigative Site 4712, Barranquilla, 080020, Colombia|Investigative Site 4705, Cali, 760035, Colombia|Investigative Site 4709, Zipaquirá, 250252, Colombia|Investigative Site 2106, Sokolov, 356 01, Czechia|Investigative Site 2107, Znojmo, 669 03, Czechia|Investigative Site 3209, Boulogne-Billancourt, 92100, France|Investigative Site 3205, Lille, 59000, France|Investigative Site 2201, Batumi, 6010, Georgia|Investigative Site 2202, Kutaisi, 4600, Georgia|Investigative Site 2208, Tbilisi, 0102, Georgia|Investigative Site 2205, Tbilisi, 0112, Georgia|Investigative Site 2211, Tbilisi, 0144, Georgia|Investigative Site 2204, Tbilisi, 0159, Georgia|Investigative Site 2206, Tbilisi, 0159, Georgia|Investigative Site 2207, Tbilisi, 0159, Georgia|Investigative Site 2209, Tbilisi, 0159, Georgia|Investigative Site 2212, Tbilisi, 0159, Georgia|Investigative Site 2213, Tbilisi, 0159, Georgia|Investigative Site 2214, Tbilisi, 0159, Georgia|Investigative Site 2210, Tbilisi, 0186, Georgia|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, Hong Kong|Investigative Site 2311, Baja, 6500, Hungary|Investigative Site 2312, Budapest, 1097, Hungary|Investigative Site 2304, Budapest, 1115, Hungary|Investigative Site 2306, Győr, 9023, Hungary|Investigative Site 2309, Kaposvár, 7400, Hungary|Investigative Site 2310, Kistarcsa, 2143, Hungary|Investigative Site 2316, Nagykanizsa, 8800, Hungary|Investigative Site 3913, Afula, 1384111, Israel|Investigative Site 3902, Ashkelon, 7830604, Israel|Investigative Site 3905, Jerusalem, 9103102, Israel|Investigative Site 3911, Tel Aviv, 6971028, Israel|Investigative Site 3903, Tiberias, 1528001, Israel|Investigative Site 3408, Genova, 16132, Italy|Investigative Site 3407, Messina, 98125, Italy|Investigative Site 3405, Milano, 20162, Italy|Investigative Site 3406, Napoli, 80131, Italy|Investigative Site 3402, Pavia, 27100, Italy|Investigative Site 3409, Reggio Calabria, 89124, Italy|Investigative Site 5207, Ansan, 15355, Korea, Republic of|Investigative Site 5203, Anyang, 14068, Korea, Republic of|Investigative Site 5218, Cheonan, 31151, Korea, Republic of|Investigative Site 5204, Daejeon, 35015, Korea, Republic of|Investigative Site 5205, Goyang, 10444, Korea, Republic of|Investigative Site 5215, Guri-si, 11923, Korea, Republic of|Investigative Site 5213, Seoul, 03080, Korea, Republic of|Investigative Site 5208, Seoul, 05030, Korea, Republic of|Investigative Site 5212, Wŏnju, 26426, Korea, Republic of|Investigative Site 6208, Klang, 41200, Malaysia|Investigative Site 6203, Kota Bharu, 15586, Malaysia|Investigative Site 6207, Kota Bharu, 16150, Malaysia|Investigative Site 6202, Kuala Lumpur, 59100, Malaysia|Investigative Site 6204, Kuantan, 25100, Malaysia|Investigative Site 6205, Kulim, 09000, Malaysia|Investigative Site 6210, Pulau Pinang, 10450, Malaysia|Investigative Site 6206, Seri Manjung, 32040, Malaysia|Investigative Site 6201, Sungai Petani, 08000, Malaysia|Investigative Site 4307, Cuernavaca, 62250, Mexico|Investigative Site 4313, Guadalajara, 44130, Mexico|Investigative Site 4304, Guadalajara, 44600, Mexico|Investigative Site 4319, Guadalajara, 44620, Mexico|Investigative Site 4325, Mexico City, 04100, Mexico|Investigative Site 4311, Mexico City, 06100, Mexico|Investigative Site 4302, Mexico City, 06700, Mexico|Investigative Site 4320, Monterrey, 64310, Mexico|Investigative Site 4315, Morelia, 58249, Mexico|Investigative Site 4324, Morelia, 58260, Mexico|Investigative Site 4316, Mérida, 97000, Mexico|Investigative Site 4301, Mérida, 97130, Mexico|Investigative Site 4310, Veracruz, 91900, Mexico|Investigative Site 4305, Xalapa, 91193, Mexico|Investigative Site 4312, Zapopan, 45030, Mexico|Investigative Site 3507, Alkmaar, 1815 JD, Netherlands|Investigative Site 3505, Amersfoort, 3813 TZ, Netherlands|Investigative Site 3503, Groningen, 2713, Netherlands|Investigative Site 1304, Bitola, 7000, North Macedonia|Investigative Site 1305, Shtip, 2000, North Macedonia|Investigative Site 1301, Skopje, 1000, North Macedonia|Investigative Site 1303, Skopje, 1000, North Macedonia|Investigative Site 1302, Struga, 6330, North Macedonia|Investigative Site 2421, Kraków, 31-637, Poland|Investigative Site 2414, Warsaw, 02-507, Poland|Investigative Site 2412, Zabrze, 41-800, Poland|Investigative Site 3604, Aveiro, 3814-501, Portugal|Investigative Site 3603, Lisboa, 2674-514, Portugal|Investigative Site 3607, Lisboa, 2790-134, Portugal|Investigative Site 3605, Vila Nova De Gaia, 4400-129, Portugal|Investigative Site 1412, Oradea, 410469, Romania|Investigative Site 2501, Belgrade, 11000, Serbia|Investigative Site 2508, Kragujevac, 34000, Serbia|Investigative Site 2510, Krusevac, 37000, Serbia|Investigative Site 2505, Niš, 18000, Serbia|Investigative Site 2514, Užice, 31000, Serbia|Investigative Site 2503, Vršac, 26300, Serbia|Investigative Site 2511, Zaječar, 19000, Serbia|Investigative Site 6401, Singapore, 119074, Singapore|Investigative Site 6403, Singapore, 169856, Singapore|Investigative Site 6404, Singapore, 529889, Singapore|Investigative Site 2604, Košice, 04001, Slovakia|Investigative Site 2606, Košice, 04011, Slovakia|Investigative Site 2603, Svidník, 08901, Slovakia|Investigative Site 3716, Barcelona, 08036, Spain|Investigative Site 3707, Barcelona, 08907, Spain|Investigative Site 3706, Barcelona, 25198, Spain|Investigative Site 6512, Changhua, 50006, Taiwan|Investigative Site 6502, Hualien City, 97002, Taiwan|Investigative Site 6501, Kaohsiung, 81362, Taiwan|Investigative Site 6504, New Taipei City, 220, Taiwan|Investigative Site 6506, Taichung, 40201, Taiwan|Investigative Site 6510, Taichung, 40447, Taiwan|Investigative Site 6507, Taichung, 433, Taiwan|Investigative Site 6503, Tainan, 71004, Taiwan|Investigative Site 6509, Taipei, 10002, Taiwan|Investigative Site 6511, Taipei, 11031, Taiwan|Investigative Site 2712, Dnipro, 49102, Ukraine|Investigative Site 2714, Ivano-Frankivs'k, 76018, Ukraine|Investigative Site 2717, Kharkiv, 61002, Ukraine|Investigative Site 2713, Kharkiv, 61039, Ukraine|Investigative Site 2721, Kharkiv, 61039, Ukraine|Investigative Site 2704, Kharkiv, 61103, Ukraine|Investigative Site 2707, Kharkiv, 61106, Ukraine|Investigative Site 2706, Kyiv, 01601, Ukraine|Investigative Site 2703, Kyiv, 02125, Ukraine|Investigative Site 2709, Kyiv, 03680, Ukraine|Investigative Site 2705, Kyiv, 04050, Ukraine|Investigative Site 2710, Kyiv, 04114, Ukraine|Investigative Site 2716, Kyiv, 04114, Ukraine|Investigative Site 2718, Ternopil', 46002, Ukraine|Investigative Site 2719, Zaporizhzhya, 69600, Ukraine|Investigative Site 2715, Zhytomyr, 10002, Ukraine|Investigative Site 3815, Coventry, CV2 2DX, United Kingdom|Investigative Site 3804, Nottingham, NG5 1PB, United Kingdom|Investigative Site 3801, Swansea, SA6 6NL, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03710291

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress