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Metabolic AcidosisPhase 3VALOR-CKDNCT03710291

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

A Phase 3 study testing TRC101 in people with Metabolic Acidosis and Chronic Kidney Disease, run by Tricida, Inc. at 203 sites in 34 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Metabolic Acidosis, Chronic Kidney Disease
What is being tested?
TRC101
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,480 participants
Where
203 sitesin 34 countries
Study dates
20 Nov 2018to 27 Sep 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

203 sites in 34 countries.

203 sites in 34 countries

United States20 sites

  • Investigative Site 4127

    Augusta, Georgia, 30904

  • Investigative Site 4136

    Azusa, California, 91702

  • Investigative Site 4124

    Bethlehem, Pennsylvania, 18017

  • Investigative Site 4157

    Boca Raton, Florida, 33431

  • Investigative Site 4146

    Bradenton, Florida, 34209

  • Investigative Site 4102

    Coral Springs, Florida, 33071

  • Investigative Site 4148

    Denver, Colorado, 80230

  • Investigative Site 4153

    Fort Lauderdale, Florida, 33308

  • Investigative Site 4141

    Greenbelt, Maryland, 20770

  • Investigative Site 4108

    Greenville, North Carolina, 27834

  • Investigative Site 4122

    Hollywood, Florida, 33021

  • Investigative Site 4123

    Hollywood, Florida, 33024

  • Investigative Site 4155

    Kansas City, Missouri, 64111

  • Investigative Site 4106

    Kinston, North Carolina, 28504

  • Investigative Site 4104

    Miami, Florida, 33015

  • Investigative Site 4130

    Miami Lakes, Florida, 33014

  • Investigative Site 4132

    Nashville, Tennessee, 37205

  • Investigative Site 4107

    New Bern, North Carolina, 28562

  • Investigative Site 4116

    Port Charlotte, Florida, 33952

  • Investigative Site 4152

    Tampa, Florida, 33637

Other trials in United States

Ukraine16 sites

  • Investigative Site 2712

    Dnipro, 49102

  • Investigative Site 2714

    Ivano-Frankivsk, 76018

  • Investigative Site 2717

    Kharkiv, 61002

  • Investigative Site 2713

    Kharkiv, 61039

  • Investigative Site 2721

    Kharkiv, 61039

  • Investigative Site 2704

    Kharkiv, 61103

  • Investigative Site 2707

    Kharkiv, 61106

  • Investigative Site 2706

    Kyiv, 01601

  • Investigative Site 2703

    Kyiv, 02125

  • Investigative Site 2709

    Kyiv, 03680

  • Investigative Site 2705

    Kyiv, 04050

  • Investigative Site 2710

    Kyiv, 04114

  • Investigative Site 2716

    Kyiv, 04114

  • Investigative Site 2718

    Ternopil, 46002

  • Investigative Site 2719

    Zaporizhzhya, 69600

  • Investigative Site 2715

    Zhytomyr, 10002

Other trials in Ukraine

Mexico15 sites

  • Investigative Site 4307

    Cuernavaca, 62250

  • Investigative Site 4313

    Guadalajara, 44130

  • Investigative Site 4304

    Guadalajara, 44600

  • Investigative Site 4319

    Guadalajara, 44620

  • Investigative Site 4316

    Mérida, 97000

  • Investigative Site 4301

    Mérida, 97130

  • Investigative Site 4325

    Mexico City, 04100

  • Investigative Site 4311

    Mexico City, 06100

  • Investigative Site 4302

    Mexico City, 06700

  • Investigative Site 4320

    Monterrey, 64310

  • Investigative Site 4315

    Morelia, 58249

  • Investigative Site 4324

    Morelia, 58260

  • Investigative Site 4310

    Veracruz, 91900

  • Investigative Site 4305

    Xalapa, 91193

  • Investigative Site 4312

    Zapopan, 45030

Other trials in Mexico

Georgia13 sites

  • Investigative Site 2201

    Batumi, 6010

  • Investigative Site 2202

    Kutaisi, 4600

  • Investigative Site 2208

    Tbilisi, 0102

  • Investigative Site 2205

    Tbilisi, 0112

  • Investigative Site 2211

    Tbilisi, 0144

  • Investigative Site 2204

    Tbilisi, 0159

  • Investigative Site 2206

    Tbilisi, 0159

  • Investigative Site 2207

    Tbilisi, 0159

  • Investigative Site 2209

    Tbilisi, 0159

  • Investigative Site 2212

    Tbilisi, 0159

  • Investigative Site 2213

    Tbilisi, 0159

  • Investigative Site 2214

    Tbilisi, 0159

  • Investigative Site 2210

    Tbilisi, 0186

Other trials in Georgia

Bulgaria10 sites

  • Investigative Site 1211

    Kozloduy, 3320

  • Investigative Site 1213

    Montana, 3400

  • Investigative Site 1210

    Pleven, 5800

  • Investigative Site 1205

    Rousse, 7000

  • Investigative Site 1212

    Rousse, 7000

  • Investigative Site 1206

    Sevlievo, 5400

  • Investigative Site 1204

    Sliven, 8800

  • Investigative Site 1201

    Sofia, 1612

  • Investigative Site 1208

    Veliko Tarnovo, 5000

  • Investigative Site 1203

    Yambol, 8600

Other trials in Bulgaria

Taiwan10 sites

  • Investigative Site 6512

    Changhua, 50006

  • Investigative Site 6502

    Hualien City, 97002

  • Investigative Site 6501

    Kaohsiung City, 81362

  • Investigative Site 6504

    New Taipei City, 220

  • Investigative Site 6506

    Taichung, 40201

  • Investigative Site 6510

    Taichung, 40447

  • Investigative Site 6507

    Taichung, 433

  • Investigative Site 6503

    Tainan, 71004

  • Investigative Site 6509

    Taipei, 10002

  • Investigative Site 6511

    Taipei, 11031

Other trials in Taiwan

Brazil9 sites

  • Investigative Site 4518

    Caxias do Sul, 95010-005

  • Investigative Site 4516

    Curitiba, 80060-150

  • Investigative Site 4504

    Curitiba, 80440-020

  • Investigative Site 4507

    Juiz de Fora, 36036-330

  • Investigative Site 4517

    São Paulo, 01323-903

  • Investigative Site 4508

    São Paulo, 09090-790

  • Investigative Site 4509

    São Paulo, 09715-090

  • Investigative Site 4506

    São Paulo, 15090-000

  • Investigative Site 4519

    São Paulo, 18618-686

Other trials in Brazil

Malaysia9 sites

  • Investigative Site 6208

    Klang, 41200

  • Investigative Site 6203

    Kota Bharu, 15586

  • Investigative Site 6207

    Kota Bharu, 16150

  • Investigative Site 6202

    Kuala Lumpur, 59100

  • Investigative Site 6204

    Kuantan, 25100

  • Investigative Site 6205

    Kulim, 09000

  • Investigative Site 6210

    Pulau Pinang, 10450

  • Investigative Site 6206

    Seri Manjung, 32040

  • Investigative Site 6201

    Sungai Petani, 08000

Other trials in Malaysia

South Korea9 sites

  • Investigative Site 5207

    Ansan, 15355

  • Investigative Site 5203

    Anyang, 14068

  • Investigative Site 5218

    Cheonan, 31151

  • Investigative Site 5204

    Daejeon, 35015

  • Investigative Site 5205

    Goyang, 10444

  • Investigative Site 5215

    Guri-si, 11923

  • Investigative Site 5213

    Seoul, 03080

  • Investigative Site 5208

    Seoul, 05030

  • Investigative Site 5212

    Wŏnju, 26426

Other trials in South Korea

Hungary7 sites

  • Investigative Site 2311

    Baja, 6500

  • Investigative Site 2312

    Budapest, 1097

  • Investigative Site 2304

    Budapest, 1115

  • Investigative Site 2306

    Győr, 9023

  • Investigative Site 2309

    Kaposvár, 7400

  • Investigative Site 2310

    Kistarcsa, 2143

  • Investigative Site 2316

    Nagykanizsa, 8800

Other trials in Hungary

Serbia7 sites

  • Investigative Site 2501

    Belgrade, 11000

  • Investigative Site 2508

    Kragujevac, 34000

  • Investigative Site 2510

    Kruševac, 37000

  • Investigative Site 2505

    Niš, 18000

  • Investigative Site 2514

    Užice, 31000

  • Investigative Site 2503

    Vršac, 26300

  • Investigative Site 2511

    Zaječar, 19000

Other trials in Serbia

Argentina6 sites

  • Investigative Site 4402

    Buenos Aires, B6000GMA

  • Investigative Site 4414

    Córdoba, X5000AAW

  • Investigative Site 4408

    Córdoba, X5002AOQ

  • Investigative Site 4410

    Corrientes, W3400AMZ

  • Investigative Site 4405

    Mar del Plata, B7600FYK

  • Investigative Site 4409

    San Luis, D5700CGR

Other trials in Argentina

Armenia6 sites

  • Investigative Site 2803

    Yerevan, 0014

  • Investigative Site 2809

    Yerevan, 0015

  • Investigative Site 2802

    Yerevan, 0025

  • Investigative site 2801

    Yerevan, 0052

  • Investigative Site 2805

    Yerevan, 0075

  • Investigative Site 2807

    Yerevan, 0078

Other trials in Armenia

Italy6 sites

  • Investigative Site 3408

    Genova, 16132

  • Investigative Site 3407

    Messina, 98125

  • Investigative Site 3405

    Milan, 20162

  • Investigative Site 3406

    Naples, 80131

  • Investigative Site 3402

    Pavia, 27100

  • Investigative Site 3409

    Reggio Calabria, 89124

Other trials in Italy

Canada5 sites

  • Investigative Site 4203

    Brampton, L6S 0C9

  • Investigative Site 4202

    Kitchener, N2H 5Z8

  • Investigative Site 4201

    London, N6A 5A5

  • Investigative Site 4204

    Québec, G1R 2J6

  • Investigative Site 4208

    Winnipeg, R2V 3M3

Other trials in Canada

Colombia5 sites

  • Investigative Site 4703

    Barranquilla, 080020

  • Investigative Site 4708

    Barranquilla, 080020

  • Investigative Site 4712

    Barranquilla, 080020

  • Investigative Site 4705

    Cali, 760035

  • Investigative Site 4709

    Zipaquirá, 250252

Other trials in Colombia

Israel5 sites

  • Investigative Site 3913

    Afula, 1384111

  • Investigative Site 3902

    Ashkelon, 7830604

  • Investigative Site 3905

    Jerusalem, 9103102

  • Investigative Site 3911

    Tel Aviv, 6971028

  • Investigative Site 3903

    Tiberias, 1528001

Other trials in Israel

North Macedonia5 sites

  • Investigative Site 1304

    Bitola, 7000

  • Investigative Site 1305

    Shtip, 2000

  • Investigative Site 1301

    Skopje, 1000

  • Investigative Site 1303

    Skopje, 1000

  • Investigative Site 1302

    Struga, 6330

Other trials in North Macedonia

Hong Kong4 sites

  • Investigative Site 6101

    Hong Kong

  • Investigative Site 6103

    Hong Kong

  • Investigative Site 6105

    Hong Kong

  • Investigative Site 6104

    Shatin

Other trials in Hong Kong

Portugal4 sites

  • Investigative Site 3604

    Aveiro, 3814-501

  • Investigative Site 3603

    Lisbon, 2674-514

  • Investigative Site 3607

    Lisbon, 2790-134

  • Investigative Site 3605

    Vila Nova de Gaia, 4400-129

Other trials in Portugal

Chile3 sites

  • Investigative Site 4604

    Concepción, 4070038

  • Investigative Site 4601

    Providencia, 7500739

  • Investigative Site 4602

    Temuco, 4781151

Other trials in Chile

Netherlands3 sites

  • Investigative Site 3507

    Alkmaar, 1815 JD

  • Investigative Site 3505

    Amersfoort, 3813 TZ

  • Investigative Site 3503

    Groningen, 2713

Other trials in Netherlands

Poland3 sites

  • Investigative Site 2421

    Krakow, 31-637

  • Investigative Site 2414

    Warsaw, 02-507

  • Investigative Site 2412

    Zabrze, 41-800

Other trials in Poland

Singapore3 sites

  • Investigative Site 6401

    Singapore, 119074

  • Investigative Site 6403

    Singapore, 169856

  • Investigative Site 6404

    Singapore, 529889

Other trials in Singapore

Slovakia3 sites

  • Investigative Site 2604

    Košice, 04001

  • Investigative Site 2606

    Košice, 04011

  • Investigative Site 2603

    Svidník, 08901

Other trials in Slovakia

Spain3 sites

  • Investigative Site 3716

    Barcelona, 08036

  • Investigative Site 3707

    Barcelona, 08907

  • Investigative Site 3706

    Barcelona, 25198

Other trials in Spain

United Kingdom3 sites

  • Investigative Site 3815

    Coventry, CV2 2DX

  • Investigative Site 3804

    Nottingham, NG5 1PB

  • Investigative Site 3801

    Swansea, SA6 6NL

Other trials in United Kingdom

Albania2 sites

  • Investigative Site 1103

    Shkoder, 4001

  • Investigative Site 1101

    Tirana, 1023

Other trials in Albania

Belgium2 sites

  • Investigative Site 3108

    Liège, 3108

  • Investigative Site 3103

    Liège, 4000

Other trials in Belgium

Czechia2 sites

  • Investigative Site 2106

    Sokolov, 356 01

  • Investigative Site 2107

    Znojmo, 669 03

Other trials in Czechia

France2 sites

  • Investigative Site 3209

    Boulogne-Billancourt, 92100

  • Investigative Site 3205

    Lille, 59000

Other trials in France

Australia1 site

  • Investigative Site 5101

    Gosford, 2250

Other trials in Australia

Belarus1 site

  • Investigative Site 1502

    Grodno, 230017

Other trials in Belarus

Romania1 site

  • Investigative Site 1412

    Oradea, 410469

Other trials in Romania

About this study

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

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.

Read the 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.

Being tested
TRC101, Placebo
Keywords
serum bicarbonate, renal outcomes, TRC101, eGFR, veverimer
Medical subject headings
Acidosis, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRC101Drug

    Also called Veverimer

    Oral, non-absorbed, polymeric hydrochloric acid binder

  • PlaceboDrug

    Placebo comparator

Study groups in NCT03710291
Study groupRoleWhat they receive
TRC101ExperimentalNot described
Receives: Drug: TRC101
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression of chronic kidney disease

    Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death.

    Measured: Through study completion, up to approximately 6 years.

Secondary outcomes (11)

  1. 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.

    Measured: Through study completion, up to approximately 6 years.

  2. Physical functioning (subjective)

    Kidney Disease Quality of Life Physical Functioning Survey.

    Measured: 18 months after randomization.

  3. Physical functioning (objective)

    Repeated chair stand test.

    Measured: 18 months after randomization.

  4. ESRD or renal death

    Time to ESRD or renal death.

    Measured: Through study completion, up to approximately 6 years.

  5. Primary outcome measure OR cardiovascular death

    Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death; cardiovascular death.

    Measured: Through study completion, up to approximately 6 years.

  6. Serum creatinine

    Time to first occurrence of a confirmed doubling of serum creatinine.

    Measured: Through study completion, up to approximately 6 years.

  7. ≥50% reduction in eGFR

    Time to first occurrence of a confirmed ≥50% reduction in eGFR.

    Measured: Through study completion, up to approximately 6 years.

  8. ≥40% reduction in eGFR

    Time to first occurrence of a confirmed ≥40% reduction in eGFR.

    Measured: Through study completion, up to approximately 6 years.

  9. All-cause hospitalization

    Frequency of all-cause hospitalization.

    Measured: Through study completion, up to approximately 6 years.

  10. Cardiovascular death

    Time to cardiovascular death.

    Measured: Through study completion, up to approximately 6 years.

  11. All-cause mortality

    Time to all-cause mortality.

    Measured: Through study completion, up to approximately 6 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2018
  2. Study start20 Nov 2018
  3. Primary completion23 Aug 2022
  4. Study completion27 Sep 2022

Why it stopped: Administrative reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03710291
Sponsor's protocol ID
TRCA-303
Other IDs
2018-001303-36, 2018
Acronym
VALOR-CKD
Status last verified
Oct 2022
First submitted
11 Oct 2018
Last updated
14 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38261535

  • 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.

    PubMed 34009141

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TRC101 in people with Metabolic Acidosis and Chronic Kidney Disease, run by Tricida, Inc. at 203 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 203 sites in United States, Ukraine, Mexico, Georgia, Bulgaria and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Administrative reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression of chronic kidney disease (time frame: Through study completion, up to approximately 6 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03710291, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.

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