Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis

NCT03710291 | Terminated Phase 3 DMC FDA Drug

• 2 other identifiers: TRCA-3032018-001303-36
• Study Type: interventional
• Target: 1,480
• Locations: 32 countries
• Sites: 196

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.

Conditions

Metabolic Acidosis; Chronic Kidney Disease

Keywords

serum bicarbonate; renal outcomes; TRC101; eGFR; veverimer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Death (all-cause), ESRD or a confirmed ≥50% reduction in eGFR

  Through study completion, up to approximately 6 years.

• Physical functioning (subjective)

  18 months after randomization.

• Physical functioning (objective)

  18 months after randomization.

• ESRD or renal death

  Through study completion, up to approximately 6 years.

• Primary outcome measure OR cardiovascular death

  Through study completion, up to approximately 6 years.

Other Outcomes (1)

• Safety of TRC101

  Through study completion, up to approximately 6 years.

Study Arms (2)

TRC101

EXPERIMENTAL

Drug: TRC101

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TRC101 DRUG

Oral, non-absorbed, polymeric hydrochloric acid binder

Also known as: Veverimer

TRC101

Placebo DRUG

Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tricida, Inc.: lead

Study Sites (203)

Investigative Site 4136

Azusa, California, 91702, United States

Location

Investigative Site 4148

Denver, Colorado, 80230, United States

Location

Investigative Site 4157

Boca Raton, Florida, 33431, United States

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Investigative Site 4146

Bradenton, Florida, 34209, United States

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Investigative Site 4102

Coral Springs, Florida, 33071, United States

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Investigative Site 4153

Fort Lauderdale, Florida, 33308, United States

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Investigative Site 4122

Hollywood, Florida, 33021, United States

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Investigative Site 4123

Hollywood, Florida, 33024, United States

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Investigative Site 4104

Miami, Florida, 33015, United States

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Investigative Site 4130

Miami Lakes, Florida, 33014, United States

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Investigative Site 4116

Port Charlotte, Florida, 33952, United States

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Investigative Site 4152

Tampa, Florida, 33637, United States

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Investigative Site 4127

Augusta, Georgia, 30904, United States

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Investigative Site 4141

Greenbelt, Maryland, 20770, United States

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Investigative Site 4155

Kansas City, Missouri, 64111, United States

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Investigative Site 4108

Greenville, North Carolina, 27834, United States

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Investigative Site 4106

Kinston, North Carolina, 28504, United States

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Investigative Site 4107

New Bern, North Carolina, 28562, United States

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Investigative Site 4124

Bethlehem, Pennsylvania, 18017, United States

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Investigative Site 4132

Nashville, Tennessee, 37205, United States

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Investigative Site 1103

Shkodër, 4001, Albania

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Investigative Site 1101

Tirana, 1023, Albania

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Investigative Site 4402

Buenos Aires, B6000GMA, Argentina

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Investigative Site 4410

Corrientes, W3400AMZ, Argentina

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Investigative Site 4414

Córdoba, X5000AAW, Argentina

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Investigative Site 4408

Córdoba, X5002AOQ, Argentina

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Investigative Site 4405

Mar del Plata, B7600FYK, Argentina

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Investigative Site 4409

San Luis, D5700CGR, Argentina

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Investigative Site 2803

Yerevan, 0014, Armenia

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Investigative Site 2809

Yerevan, 0015, Armenia

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Investigative Site 2802

Yerevan, 0025, Armenia

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Investigative site 2801

Yerevan, 0052, Armenia

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Investigative Site 2805

Yerevan, 0075, Armenia

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Investigative Site 2807

Yerevan, 0078, Armenia

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Investigative Site 5101

Gosford, 2250, Australia

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Investigative Site 1502

Grodno, 230017, Belarus

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Investigative Site 3108

Liège, 3108, Belgium

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Investigative Site 3103

Liège, 4000, Belgium

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Investigative Site 4518

Caxias do Sul, 95010-005, Brazil

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Investigative Site 4516

Curitiba, 80060-150, Brazil

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Investigative Site 4504

Curitiba, 80440-020, Brazil

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Investigative Site 4507

Juiz de Fora, 36036-330, Brazil

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Investigative Site 4517

São Paulo, 01323-903, Brazil

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Investigative Site 4508

São Paulo, 09090-790, Brazil

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Investigative Site 4509

São Paulo, 09715-090, Brazil

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Investigative Site 4506

São Paulo, 15090-000, Brazil

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Investigative Site 4519

São Paulo, 18618-686, Brazil

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Investigative Site 1211

Kozloduy, 3320, Bulgaria

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Investigative Site 1213

Montana, 3400, Bulgaria

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Investigative Site 1210

Pleven, 5800, Bulgaria

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Investigative Site 1205

Rousse, 7000, Bulgaria

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Investigative Site 1212

Rousse, 7000, Bulgaria

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Investigative Site 1206

Sevlievo, 5400, Bulgaria

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Investigative Site 1204

Sliven, 8800, Bulgaria

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Investigative Site 1201

Sofia, 1612, Bulgaria

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Investigative Site 1208

Veliko Tarnovo, 5000, Bulgaria

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Investigative Site 1203

Yambol, 8600, Bulgaria

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Investigative Site 4203

Brampton, L6S 0C9, Canada

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Investigative Site 4202

Kitchener, N2H 5Z8, Canada

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Investigative Site 4201

London, N6A 5A5, Canada

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Investigative Site 4204

Québec, G1R 2J6, Canada

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Investigative Site 4208

Winnipeg, R2V 3M3, Canada

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Investigative Site 4604

Concepción, 4070038, Chile

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Investigative Site 4601

Providencia, 7500739, Chile

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Investigative Site 4602

Temuco, 4781151, Chile

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Investigative Site 4703

Barranquilla, 080020, Colombia

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Investigative Site 4708

Barranquilla, 080020, Colombia

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Investigative Site 4712

Barranquilla, 080020, Colombia

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Investigative Site 4705

Cali, 760035, Colombia

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Investigative Site 4709

Zipaquirá, 250252, Colombia

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Investigative Site 2106

Sokolov, 356 01, Czechia

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Investigative Site 2107

Znojmo, 669 03, Czechia

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Investigative Site 3209

Boulogne-Billancourt, 92100, France

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Investigative Site 3205

Lille, 59000, France

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Investigative Site 2201

Batumi, 6010, Georgia

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Investigative Site 2202

Kutaisi, 4600, Georgia

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Investigative Site 2208

Tbilisi, 0102, Georgia

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Investigative Site 2205

Tbilisi, 0112, Georgia

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Investigative Site 2211

Tbilisi, 0144, Georgia

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Investigative Site 2204

Tbilisi, 0159, Georgia

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Investigative Site 2206

Tbilisi, 0159, Georgia

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Investigative Site 2207

Tbilisi, 0159, Georgia

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Investigative Site 2209

Tbilisi, 0159, Georgia

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Investigative Site 2212

Tbilisi, 0159, Georgia

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Investigative Site 2213

Tbilisi, 0159, Georgia

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Investigative Site 2214

Tbilisi, 0159, Georgia

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Investigative Site 2210

Tbilisi, 0186, Georgia

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Investigative Site 6101

Hong Kong, Hong Kong

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Investigative Site 6103

Hong Kong, Hong Kong

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Investigative Site 6105

Hong Kong, Hong Kong

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Investigative Site 6104

Shatin, Hong Kong

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Investigative Site 2311

Baja, 6500, Hungary

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Investigative Site 2312

Budapest, 1097, Hungary

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Investigative Site 2304

Budapest, 1115, Hungary

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Investigative Site 2306

Győr, 9023, Hungary

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Investigative Site 2309

Kaposvár, 7400, Hungary

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Investigative Site 2310

Kistarcsa, 2143, Hungary

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Investigative Site 2316

Nagykanizsa, 8800, Hungary

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Investigative Site 3913

Afula, 1384111, Israel

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Investigative Site 3902

Ashkelon, 7830604, Israel

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Investigative Site 3905

Jerusalem, 9103102, Israel

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Investigative Site 3911

Tel Aviv, 6971028, Israel

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Investigative Site 3903

Tiberias, 1528001, Israel

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Investigative Site 3408

Genova, 16132, Italy

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Investigative Site 3407

Messina, 98125, Italy

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Investigative Site 3405

Milan, 20162, Italy

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Investigative Site 3406

Napoli, 80131, Italy

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Investigative Site 3402

Pavia, 27100, Italy

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Investigative Site 3409

Reggio Calabria, 89124, Italy

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Investigative Site 6208

Klang, 41200, Malaysia

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Investigative Site 6203

Kota Bharu, 15586, Malaysia

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Investigative Site 6207

Kota Bharu, 16150, Malaysia

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Investigative Site 6202

Kuala Lumpur, 59100, Malaysia

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Investigative Site 6204

Kuantan, 25100, Malaysia

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Investigative Site 6205

Kulim, 09000, Malaysia

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Investigative Site 6210

Pulau Pinang, 10450, Malaysia

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Investigative Site 6206

Seri Manjung, 32040, Malaysia

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Investigative Site 6201

Sungai Petani, 08000, Malaysia

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Investigative Site 4307

Cuernavaca, 62250, Mexico

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Investigative Site 4313

Guadalajara, 44130, Mexico

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Investigative Site 4304

Guadalajara, 44600, Mexico

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Investigative Site 4319

Guadalajara, 44620, Mexico

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Investigative Site 4325

Mexico City, 04100, Mexico

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Investigative Site 4311

Mexico City, 06100, Mexico

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Investigative Site 4302

Mexico City, 06700, Mexico

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Investigative Site 4316

Mérida, 97000, Mexico

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Investigative Site 4301

Mérida, 97130, Mexico

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Investigative Site 4320

Monterrey, 64310, Mexico

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Investigative Site 4315

Morelia, 58249, Mexico

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Investigative Site 4324

Morelia, 58260, Mexico

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Investigative Site 4310

Veracruz, 91900, Mexico

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Investigative Site 4305

Xalapa, 91193, Mexico

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Investigative Site 4312

Zapopan, 45030, Mexico

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Investigative Site 3507

Alkmaar, 1815 JD, Netherlands

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Investigative Site 3505

Amersfoort, 3813 TZ, Netherlands

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Investigative Site 3503

Groningen, 2713, Netherlands

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Investigative Site 1304

Bitola, 7000, North Macedonia

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Investigative Site 1305

Shtip, 2000, North Macedonia

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Investigative Site 1301

Skopje, 1000, North Macedonia

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Investigative Site 1303

Skopje, 1000, North Macedonia

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Investigative Site 1302

Struga, 6330, North Macedonia

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Investigative Site 2421

Krakow, 31-637, Poland

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Investigative Site 2414

Warsaw, 02-507, Poland

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Investigative Site 2412

Zabrze, 41-800, Poland

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Investigative Site 3604

Aveiro, 3814-501, Portugal

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Investigative Site 3603

Lisbon, 2674-514, Portugal

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Investigative Site 3607

Lisbon, 2790-134, Portugal

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Investigative Site 3605

Vila Nova de Gaia, 4400-129, Portugal

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Investigative Site 1412

Oradea, 410469, Romania

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Investigative Site 2501

Belgrade, 11000, Serbia

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Investigative Site 2508

Kragujevac, 34000, Serbia

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Investigative Site 2510

Kruševac, 37000, Serbia

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Investigative Site 2505

Niš, 18000, Serbia

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Investigative Site 2514

Užice, 31000, Serbia

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Investigative Site 2503

Vršac, 26300, Serbia

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Investigative Site 2511

Zaječar, 19000, Serbia

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Investigative Site 6401

Singapore, 119074, Singapore

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Investigative Site 6403

Singapore, 169856, Singapore

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Investigative Site 6404

Singapore, 529889, Singapore

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Investigative Site 2604

Košice, 04001, Slovakia

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Investigative Site 2606

Košice, 04011, Slovakia

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Investigative Site 2603

Svidník, 08901, Slovakia

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Investigative Site 5207

Ansan, 15355, South Korea

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Investigative Site 5203

Anyang, 14068, South Korea

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Investigative Site 5218

Cheonan, 31151, South Korea

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Investigative Site 5204

Daejeon, 35015, South Korea

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Investigative Site 5205

Goyang, 10444, South Korea

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Investigative Site 5215

Guri-si, 11923, South Korea

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Investigative Site 5213

Seoul, 03080, South Korea

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Investigative Site 5208

Seoul, 05030, South Korea

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Investigative Site 5212

Wŏnju, 26426, South Korea

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Investigative Site 3716

Barcelona, 08036, Spain

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Investigative Site 3707

Barcelona, 08907, Spain

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Investigative Site 3706

Barcelona, 25198, Spain

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Investigative Site 6512

Changhua, 50006, Taiwan

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Investigative Site 6502

Hualien City, 97002, Taiwan

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Investigative Site 6501

Kaohsiung City, 81362, Taiwan

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Investigative Site 6504

New Taipei City, 220, Taiwan

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Investigative Site 6506

Taichung, 40201, Taiwan

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Investigative Site 6510

Taichung, 40447, Taiwan

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Investigative Site 6507

Taichung, 433, Taiwan

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Investigative Site 6503

Tainan, 71004, Taiwan

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Investigative Site 6509

Taipei, 10002, Taiwan

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Investigative Site 6511

Taipei, 11031, Taiwan

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Investigative Site 2712

Dnipro, 49102, Ukraine

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Investigative Site 2714

Ivano-Frankivsk, 76018, Ukraine

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Investigative Site 2717

Kharkiv, 61002, Ukraine

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Investigative Site 2713

Kharkiv, 61039, Ukraine

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Investigative Site 2721

Kharkiv, 61039, Ukraine

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Investigative Site 2704

Kharkiv, 61103, Ukraine

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Investigative Site 2707

Kharkiv, 61106, Ukraine

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Investigative Site 2706

Kyiv, 01601, Ukraine

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Investigative Site 2703

Kyiv, 02125, Ukraine

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Investigative Site 2709

Kyiv, 03680, Ukraine

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Investigative Site 2705

Kyiv, 04050, Ukraine

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Investigative Site 2710

Kyiv, 04114, Ukraine

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Investigative Site 2716

Kyiv, 04114, Ukraine

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Investigative Site 2718

Ternopil, 46002, Ukraine

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Investigative Site 2719

Zaporizhzhya, 69600, Ukraine

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Investigative Site 2715

Zhytomyr, 10002, Ukraine

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Investigative Site 3815

Coventry, CV2 2DX, United Kingdom

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Investigative Site 3804

Nottingham, NG5 1PB, United Kingdom

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Investigative Site 3801

Swansea, SA6 6NL, United Kingdom

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Related Publications (2)

• 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.

  PMID: 38261535 DERIVED

• 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.

  PMID: 34009141 DERIVED

MeSH Terms

Conditions

Acidosis; Renal Insufficiency, Chronic

Interventions

veverimer

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 18, 2018
• Study Start: November 20, 2018
• Primary Completion: August 23, 2022
• Study Completion: September 27, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (5); BU (10); CZ (2); SG (3); FR (2); US (20); PL (3); BE (2); CO (5); MY (9); TW (10); GB (3); IL (5); RO (1); ME (15); KR (9); SL (3); AU (1); HU (7); CL (3); BR (9); AR (6); NL (3); PT (4); CA (5); AL (2); HK (4); ES (3); SE (7); IT (6); GE (13); UA (16)