Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis (VALOR-CKD)

October 13, 2022 updated by: Tricida, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Albania
      • Shkodër, Albania, 4001
        • Investigative Site 1103
      • Tirana, Albania, 1023
        • Investigative Site 1101
  • Argentina
      • Buenos Aires, Argentina, B6000GMA
        • Investigative Site 4402
      • Corrientes, Argentina, W3400AMZ
        • Investigative Site 4410
      • Córdoba, Argentina, X5000AAW
        • Investigative Site 4414
      • Córdoba, Argentina, X5002AOQ
        • Investigative Site 4408
      • Mar Del Plata, Argentina, B7600FYK
        • Investigative Site 4405
      • San Luis, Argentina, D5700CGR
        • Investigative Site 4409
  • Armenia
      • Yerevan, Armenia, 0014
        • Investigative Site 2803
      • Yerevan, Armenia, 0015
        • Investigative Site 2809
      • Yerevan, Armenia, 0025
        • Investigative Site 2802
      • Yerevan, Armenia, 0052
        • Investigative site 2801
      • Yerevan, Armenia, 0075
        • Investigative Site 2805
      • Yerevan, Armenia, 0078
        • Investigative Site 2807
  • Australia
      • Gosford, Australia, 2250
        • Investigative Site 5101
  • Belarus
      • Grodno, Belarus, 230017
        • Investigative Site 1502
  • Belgium
      • Liège, Belgium, 3108
        • Investigative Site 3108
      • Liège, Belgium, 4000
        • Investigative Site 3103
  • Brazil
      • Caxias Do Sul, Brazil, 95010-005
        • Investigative Site 4518
      • Curitiba, Brazil, 80060-150
        • Investigative Site 4516
      • Curitiba, Brazil, 80440-020
        • Investigative Site 4504
      • Juiz De Fora, Brazil, 36036-330
        • Investigative Site 4507
      • São Paulo, Brazil, 01323-903
        • Investigative Site 4517
      • São Paulo, Brazil, 09090-790
        • Investigative Site 4508
      • São Paulo, Brazil, 09715-090
        • Investigative Site 4509
      • São Paulo, Brazil, 15090-000
        • Investigative Site 4506
      • São Paulo, Brazil, 18618-686
        • Investigative Site 4519
  • Bulgaria
      • Kozloduy, Bulgaria, 3320
        • Investigative Site 1211
      • Montana, Bulgaria, 3400
        • Investigative Site 1213
      • Pleven, Bulgaria, 5800
        • Investigative Site 1210
      • Ruse, Bulgaria, 7000
        • Investigative Site 1205
      • Ruse, Bulgaria, 7000
        • Investigative Site 1212
      • Sevlievo, Bulgaria, 5400
        • Investigative Site 1206
      • Sliven, Bulgaria, 8800
        • Investigative Site 1204
      • Sofia, Bulgaria, 1612
        • Investigative Site 1201
      • Veliko Tarnovo, Bulgaria, 5000
        • Investigative Site 1208
      • Yambol, Bulgaria, 8600
        • Investigative Site 1203
  • Canada
      • Brampton, Canada, L6S 0C9
        • Investigative Site 4203
      • Kitchener, Canada, N2H 5Z8
        • Investigative Site 4202
      • London, Canada, N6A 5A5
        • Investigative Site 4201
      • Québec, Canada, G1R 2J6
        • Investigative Site 4204
      • Winnipeg, Canada, R2V 3M3
        • Investigative Site 4208
  • Chile
      • Concepción, Chile, 4070038
        • Investigative Site 4604
      • Providencia, Chile, 7500739
        • Investigative Site 4601
      • Temuco, Chile, 4781151
        • Investigative Site 4602
  • Colombia
      • Barranquilla, Colombia, 080020
        • Investigative Site 4703
      • Barranquilla, Colombia, 080020
        • Investigative Site 4708
      • Barranquilla, Colombia, 080020
        • Investigative Site 4712
      • Cali, Colombia, 760035
        • Investigative Site 4705
      • Zipaquirá, Colombia, 250252
        • Investigative Site 4709
  • Czechia
      • Sokolov, Czechia, 356 01
        • Investigative Site 2106
      • Znojmo, Czechia, 669 03
        • Investigative Site 2107
  • France
      • Boulogne-Billancourt, France, 92100
        • Investigative Site 3209
      • Lille, France, 59000
        • Investigative Site 3205
  • Georgia
      • Batumi, Georgia, 6010
        • Investigative Site 2201
      • Kutaisi, Georgia, 4600
        • Investigative Site 2202
      • Tbilisi, Georgia, 0102
        • Investigative Site 2208
      • Tbilisi, Georgia, 0112
        • Investigative Site 2205
      • Tbilisi, Georgia, 0144
        • Investigative Site 2211
      • Tbilisi, Georgia, 0159
        • Investigative Site 2204
      • Tbilisi, Georgia, 0159
        • Investigative Site 2206
      • Tbilisi, Georgia, 0159
        • Investigative Site 2207
      • Tbilisi, Georgia, 0159
        • Investigative Site 2209
      • Tbilisi, Georgia, 0159
        • Investigative Site 2212
      • Tbilisi, Georgia, 0159
        • Investigative Site 2213
      • Tbilisi, Georgia, 0159
        • Investigative Site 2214
      • Tbilisi, Georgia, 0186
        • Investigative Site 2210
  • Hong Kong
      • Hong Kong, Hong Kong
        • Investigative Site 6101
      • Hong Kong, Hong Kong
        • Investigative Site 6103
      • Hong Kong, Hong Kong
        • Investigative Site 6105
      • Sha Tin, Hong Kong
        • Investigative Site 6104
  • Hungary
      • Baja, Hungary, 6500
        • Investigative Site 2311
      • Budapest, Hungary, 1097
        • Investigative Site 2312
      • Budapest, Hungary, 1115
        • Investigative Site 2304
      • Győr, Hungary, 9023
        • Investigative Site 2306
      • Kaposvár, Hungary, 7400
        • Investigative Site 2309
      • Kistarcsa, Hungary, 2143
        • Investigative Site 2310
      • Nagykanizsa, Hungary, 8800
        • Investigative Site 2316
  • Israel
      • Afula, Israel, 1384111
        • Investigative Site 3913
      • Ashkelon, Israel, 7830604
        • Investigative Site 3902
      • Jerusalem, Israel, 9103102
        • Investigative Site 3905
      • Tel Aviv, Israel, 6971028
        • Investigative Site 3911
      • Tiberias, Israel, 1528001
        • Investigative Site 3903
  • Italy
      • Genova, Italy, 16132
        • Investigative Site 3408
      • Messina, Italy, 98125
        • Investigative Site 3407
      • Milano, Italy, 20162
        • Investigative Site 3405
      • Napoli, Italy, 80131
        • Investigative Site 3406
      • Pavia, Italy, 27100
        • Investigative Site 3402
      • Reggio Calabria, Italy, 89124
        • Investigative Site 3409
  • Korea, Republic of
      • Ansan, Korea, Republic of, 15355
        • Investigative Site 5207
      • Anyang, Korea, Republic of, 14068
        • Investigative Site 5203
      • Cheonan, Korea, Republic of, 31151
        • Investigative Site 5218
      • Daejeon, Korea, Republic of, 35015
        • Investigative Site 5204
      • Goyang, Korea, Republic of, 10444
        • Investigative Site 5205
      • Guri-si, Korea, Republic of, 11923
        • Investigative Site 5215
      • Seoul, Korea, Republic of, 03080
        • Investigative Site 5213
      • Seoul, Korea, Republic of, 05030
        • Investigative Site 5208
      • Wŏnju, Korea, Republic of, 26426
        • Investigative Site 5212
  • Malaysia
      • Klang, Malaysia, 41200
        • Investigative Site 6208
      • Kota Bharu, Malaysia, 15586
        • Investigative Site 6203
      • Kota Bharu, Malaysia, 16150
        • Investigative Site 6207
      • Kuala Lumpur, Malaysia, 59100
        • Investigative Site 6202
      • Kuantan, Malaysia, 25100
        • Investigative Site 6204
      • Kulim, Malaysia, 09000
        • Investigative Site 6205
      • Pulau Pinang, Malaysia, 10450
        • Investigative Site 6210
      • Seri Manjung, Malaysia, 32040
        • Investigative Site 6206
      • Sungai Petani, Malaysia, 08000
        • Investigative Site 6201
  • Mexico
      • Cuernavaca, Mexico, 62250
        • Investigative Site 4307
      • Guadalajara, Mexico, 44130
        • Investigative Site 4313
      • Guadalajara, Mexico, 44600
        • Investigative Site 4304
      • Guadalajara, Mexico, 44620
        • Investigative Site 4319
      • Mexico City, Mexico, 04100
        • Investigative Site 4325
      • Mexico City, Mexico, 06100
        • Investigative Site 4311
      • Mexico City, Mexico, 06700
        • Investigative Site 4302
      • Monterrey, Mexico, 64310
        • Investigative Site 4320
      • Morelia, Mexico, 58249
        • Investigative Site 4315
      • Morelia, Mexico, 58260
        • Investigative Site 4324
      • Mérida, Mexico, 97000
        • Investigative Site 4316
      • Mérida, Mexico, 97130
        • Investigative Site 4301
      • Veracruz, Mexico, 91900
        • Investigative Site 4310
      • Xalapa, Mexico, 91193
        • Investigative Site 4305
      • Zapopan, Mexico, 45030
        • Investigative Site 4312
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Investigative Site 3507
      • Amersfoort, Netherlands, 3813 TZ
        • Investigative Site 3505
      • Groningen, Netherlands, 2713
        • Investigative Site 3503
  • North Macedonia
      • Bitola, North Macedonia, 7000
        • Investigative Site 1304
      • Shtip, North Macedonia, 2000
        • Investigative Site 1305
      • Skopje, North Macedonia, 1000
        • Investigative Site 1301
      • Skopje, North Macedonia, 1000
        • Investigative Site 1303
      • Struga, North Macedonia, 6330
        • Investigative Site 1302
  • Poland
      • Kraków, Poland, 31-637
        • Investigative Site 2421
      • Warsaw, Poland, 02-507
        • Investigative Site 2414
      • Zabrze, Poland, 41-800
        • Investigative Site 2412
  • Portugal
      • Aveiro, Portugal, 3814-501
        • Investigative Site 3604
      • Lisboa, Portugal, 2674-514
        • Investigative Site 3603
      • Lisboa, Portugal, 2790-134
        • Investigative Site 3607
      • Vila Nova De Gaia, Portugal, 4400-129
        • Investigative Site 3605
  • Romania
      • Oradea, Romania, 410469
        • Investigative Site 1412
  • Serbia
      • Belgrade, Serbia, 11000
        • Investigative Site 2501
      • Kragujevac, Serbia, 34000
        • Investigative Site 2508
      • Krusevac, Serbia, 37000
        • Investigative Site 2510
      • Niš, Serbia, 18000
        • Investigative Site 2505
      • Užice, Serbia, 31000
        • Investigative Site 2514
      • Vršac, Serbia, 26300
        • Investigative Site 2503
      • Zaječar, Serbia, 19000
        • Investigative Site 2511
  • Singapore
      • Singapore, Singapore, 119074
        • Investigative Site 6401
      • Singapore, Singapore, 169856
        • Investigative Site 6403
      • Singapore, Singapore, 529889
        • Investigative Site 6404
  • Slovakia
      • Košice, Slovakia, 04001
        • Investigative Site 2604
      • Košice, Slovakia, 04011
        • Investigative Site 2606
      • Svidník, Slovakia, 08901
        • Investigative Site 2603
  • Spain
      • Barcelona, Spain, 08036
        • Investigative Site 3716
      • Barcelona, Spain, 08907
        • Investigative Site 3707
      • Barcelona, Spain, 25198
        • Investigative Site 3706
  • Taiwan
      • Changhua, Taiwan, 50006
        • Investigative Site 6512
      • Hualien City, Taiwan, 97002
        • Investigative Site 6502
      • Kaohsiung, Taiwan, 81362
        • Investigative Site 6501
      • New Taipei City, Taiwan, 220
        • Investigative Site 6504
      • Taichung, Taiwan, 40201
        • Investigative Site 6506
      • Taichung, Taiwan, 40447
        • Investigative Site 6510
      • Taichung, Taiwan, 433
        • Investigative Site 6507
      • Tainan, Taiwan, 71004
        • Investigative Site 6503
      • Taipei, Taiwan, 10002
        • Investigative Site 6509
      • Taipei, Taiwan, 11031
        • Investigative Site 6511
  • Ukraine
      • Dnipro, Ukraine, 49102
        • Investigative Site 2712
      • Ivano-Frankivs'k, Ukraine, 76018
        • Investigative Site 2714
      • Kharkiv, Ukraine, 61002
        • Investigative Site 2717
      • Kharkiv, Ukraine, 61039
        • Investigative Site 2713
      • Kharkiv, Ukraine, 61039
        • Investigative Site 2721
      • Kharkiv, Ukraine, 61103
        • Investigative Site 2704
      • Kharkiv, Ukraine, 61106
        • Investigative Site 2707
      • Kyiv, Ukraine, 01601
        • Investigative Site 2706
      • Kyiv, Ukraine, 02125
        • Investigative Site 2703
      • Kyiv, Ukraine, 03680
        • Investigative Site 2709
      • Kyiv, Ukraine, 04050
        • Investigative Site 2705
      • Kyiv, Ukraine, 04114
        • Investigative Site 2710
      • Kyiv, Ukraine, 04114
        • Investigative Site 2716
      • Ternopil', Ukraine, 46002
        • Investigative Site 2718
      • Zaporizhzhya, Ukraine, 69600
        • Investigative Site 2719
      • Zhytomyr, Ukraine, 10002
        • Investigative Site 2715
  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • Investigative Site 3815
      • Nottingham, United Kingdom, NG5 1PB
        • Investigative Site 3804
      • Swansea, United Kingdom, SA6 6NL
        • Investigative Site 3801
  • United States
    • California
      • Azusa, California, United States, 91702
        • Investigative Site 4136
    • Colorado
      • Denver, Colorado, United States, 80230
        • Investigative Site 4148
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Investigative Site 4157
      • Bradenton, Florida, United States, 34209
        • Investigative Site 4146
      • Coral Springs, Florida, United States, 33071
        • Investigative Site 4102
      • Fort Lauderdale, Florida, United States, 33308
        • Investigative Site 4153
      • Hollywood, Florida, United States, 33021
        • Investigative Site 4122
      • Hollywood, Florida, United States, 33024
        • Investigative Site 4123
      • Miami, Florida, United States, 33015
        • Investigative Site 4104
      • Miami Lakes, Florida, United States, 33014
        • Investigative Site 4130
      • Port Charlotte, Florida, United States, 33952
        • Investigative Site 4116
      • Tampa, Florida, United States, 33637
        • Investigative Site 4152
    • Georgia
      • Augusta, Georgia, United States, 30904
        • Investigative Site 4127
    • Maryland
      • Greenbelt, Maryland, United States, 20770
        • Investigative Site 4141
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Investigative Site 4155
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Investigative Site 4108
      • Kinston, North Carolina, United States, 28504
        • Investigative Site 4106
      • New Bern, North Carolina, United States, 28562
        • Investigative Site 4107
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Investigative Site 4124
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Investigative Site 4132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo comparator
Experimental: TRC101
Drug: TRC101
Oral, non-absorbed, polymeric hydrochloric acid binder
Other Names:
  • Veverimer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of chronic kidney disease
Time Frame: Through study completion, up to approximately 6 years.
Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death.
Through study completion, up to approximately 6 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death (all-cause), ESRD or a confirmed ≥50% reduction in eGFR
Time Frame: Through study completion, up to approximately 6 years.
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)
Time Frame: 18 months after randomization.
Kidney Disease Quality of Life Physical Functioning Survey.
18 months after randomization.
Physical functioning (objective)
Time Frame: 18 months after randomization.
Repeated chair stand test.
18 months after randomization.
ESRD or renal death
Time Frame: Through study completion, up to approximately 6 years.
Time to ESRD or renal death.
Through study completion, up to approximately 6 years.
Primary outcome measure OR cardiovascular death
Time Frame: Through study completion, up to approximately 6 years.
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 Frame: Through study completion, up to approximately 6 years.
Time to first occurrence of a confirmed doubling of serum creatinine.
Through study completion, up to approximately 6 years.
≥50% reduction in eGFR
Time Frame: Through study completion, up to approximately 6 years.
Time to first occurrence of a confirmed ≥50% reduction in eGFR.
Through study completion, up to approximately 6 years.
≥40% reduction in eGFR
Time Frame: Through study completion, up to approximately 6 years.
Time to first occurrence of a confirmed ≥40% reduction in eGFR.
Through study completion, up to approximately 6 years.
All-cause hospitalization
Time Frame: Through study completion, up to approximately 6 years.
Frequency of all-cause hospitalization.
Through study completion, up to approximately 6 years.
Cardiovascular death
Time Frame: Through study completion, up to approximately 6 years.
Time to cardiovascular death.
Through study completion, up to approximately 6 years.
All-cause mortality
Time Frame: Through study completion, up to approximately 6 years.
Time to all-cause mortality.
Through study completion, up to approximately 6 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of TRC101
Time Frame: Through study completion, up to approximately 6 years.
Frequency, intensity, and relationship to study drug of adverse events and serious adverse events.
Through study completion, up to approximately 6 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tricida, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2018

Primary Completion (Actual)

August 23, 2022

Study Completion (Actual)

September 27, 2022

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

October 15, 2018

First Posted (Actual)

October 18, 2018

Study Record Updates

Last Update Posted (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRCA-303
  • 2018-001303-36 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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