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

Primary Purpose

Metabolic Acidosis, Chronic Kidney Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TRC101
Placebo
Sponsored by
Tricida, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Acidosis focused on measuring serum bicarbonate, renal outcomes, TRC101, eGFR, veverimer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigative Site 4136
  • Investigative Site 4148
  • Investigative Site 4157
  • Investigative Site 4146
  • Investigative Site 4102
  • Investigative Site 4153
  • Investigative Site 4122
  • Investigative Site 4123
  • Investigative Site 4130
  • Investigative Site 4104
  • Investigative Site 4116
  • Investigative Site 4152
  • Investigative Site 4127
  • Investigative Site 4141
  • Investigative Site 4155
  • Investigative Site 4108
  • Investigative Site 4106
  • Investigative Site 4107
  • Investigative Site 4124
  • Investigative Site 4132
  • Investigative Site 1103
  • Investigative Site 1101
  • Investigative Site 4402
  • Investigative Site 4410
  • Investigative Site 4414
  • Investigative Site 4408
  • Investigative Site 4405
  • Investigative Site 4409
  • Investigative Site 2803
  • Investigative Site 2809
  • Investigative Site 2802
  • Investigative site 2801
  • Investigative Site 2805
  • Investigative Site 2807
  • Investigative Site 5101
  • Investigative Site 1502
  • Investigative Site 3108
  • Investigative Site 3103
  • Investigative Site 4518
  • Investigative Site 4516
  • Investigative Site 4504
  • Investigative Site 4507
  • Investigative Site 4517
  • Investigative Site 4508
  • Investigative Site 4509
  • Investigative Site 4506
  • Investigative Site 4519
  • Investigative Site 1211
  • Investigative Site 1213
  • Investigative Site 1210
  • Investigative Site 1205
  • Investigative Site 1212
  • Investigative Site 1206
  • Investigative Site 1204
  • Investigative Site 1201
  • Investigative Site 1208
  • Investigative Site 1203
  • Investigative Site 4203
  • Investigative Site 4202
  • Investigative Site 4201
  • Investigative Site 4204
  • Investigative Site 4208
  • Investigative Site 4604
  • Investigative Site 4601
  • Investigative Site 4602
  • Investigative Site 4703
  • Investigative Site 4708
  • Investigative Site 4712
  • Investigative Site 4705
  • Investigative Site 4709
  • Investigative Site 2106
  • Investigative Site 2107
  • Investigative Site 3209
  • Investigative Site 3205
  • Investigative Site 2201
  • Investigative Site 2202
  • Investigative Site 2208
  • Investigative Site 2205
  • Investigative Site 2211
  • Investigative Site 2204
  • Investigative Site 2206
  • Investigative Site 2207
  • Investigative Site 2209
  • Investigative Site 2212
  • Investigative Site 2213
  • Investigative Site 2214
  • Investigative Site 2210
  • Investigative Site 6101
  • Investigative Site 6103
  • Investigative Site 6105
  • Investigative Site 6104
  • Investigative Site 2311
  • Investigative Site 2312
  • Investigative Site 2304
  • Investigative Site 2306
  • Investigative Site 2309
  • Investigative Site 2310
  • Investigative Site 2316
  • Investigative Site 3913
  • Investigative Site 3902
  • Investigative Site 3905
  • Investigative Site 3911
  • Investigative Site 3903
  • Investigative Site 3408
  • Investigative Site 3407
  • Investigative Site 3405
  • Investigative Site 3406
  • Investigative Site 3402
  • Investigative Site 3409
  • Investigative Site 5207
  • Investigative Site 5203
  • Investigative Site 5218
  • Investigative Site 5204
  • Investigative Site 5205
  • Investigative Site 5215
  • Investigative Site 5213
  • Investigative Site 5208
  • Investigative Site 5212
  • Investigative Site 6208
  • Investigative Site 6203
  • Investigative Site 6207
  • Investigative Site 6202
  • Investigative Site 6204
  • Investigative Site 6205
  • Investigative Site 6210
  • Investigative Site 6206
  • Investigative Site 6201
  • Investigative Site 4307
  • Investigative Site 4313
  • Investigative Site 4304
  • Investigative Site 4319
  • Investigative Site 4325
  • Investigative Site 4311
  • Investigative Site 4302
  • Investigative Site 4320
  • Investigative Site 4315
  • Investigative Site 4324
  • Investigative Site 4316
  • Investigative Site 4301
  • Investigative Site 4310
  • Investigative Site 4305
  • Investigative Site 4312
  • Investigative Site 3507
  • Investigative Site 3505
  • Investigative Site 3503
  • Investigative Site 1304
  • Investigative Site 1305
  • Investigative Site 1301
  • Investigative Site 1303
  • Investigative Site 1302
  • Investigative Site 2421
  • Investigative Site 2414
  • Investigative Site 2412
  • Investigative Site 3604
  • Investigative Site 3603
  • Investigative Site 3607
  • Investigative Site 3605
  • Investigative Site 1412
  • Investigative Site 2501
  • Investigative Site 2508
  • Investigative Site 2510
  • Investigative Site 2505
  • Investigative Site 2514
  • Investigative Site 2503
  • Investigative Site 2511
  • Investigative Site 6401
  • Investigative Site 6403
  • Investigative Site 6404
  • Investigative Site 2604
  • Investigative Site 2606
  • Investigative Site 2603
  • Investigative Site 3716
  • Investigative Site 3707
  • Investigative Site 3706
  • Investigative Site 6512
  • Investigative Site 6502
  • Investigative Site 6501
  • Investigative Site 6504
  • Investigative Site 6506
  • Investigative Site 6510
  • Investigative Site 6507
  • Investigative Site 6503
  • Investigative Site 6509
  • Investigative Site 6511
  • Investigative Site 2712
  • Investigative Site 2714
  • Investigative Site 2717
  • Investigative Site 2713
  • Investigative Site 2721
  • Investigative Site 2704
  • Investigative Site 2707
  • Investigative Site 2706
  • Investigative Site 2703
  • Investigative Site 2709
  • Investigative Site 2705
  • Investigative Site 2710
  • Investigative Site 2716
  • Investigative Site 2718
  • Investigative Site 2719
  • Investigative Site 2715
  • Investigative Site 3815
  • Investigative Site 3804
  • Investigative Site 3801

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TRC101

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Physical functioning (subjective)
Kidney Disease Quality of Life Physical Functioning Survey.
Physical functioning (objective)
Repeated chair stand test.
ESRD or renal death
Time to ESRD or renal death.
Primary outcome measure OR cardiovascular death
Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death; cardiovascular death.
Serum creatinine
Time to first occurrence of a confirmed doubling of serum creatinine.
≥50% reduction in eGFR
Time to first occurrence of a confirmed ≥50% reduction in eGFR.
≥40% reduction in eGFR
Time to first occurrence of a confirmed ≥40% reduction in eGFR.
All-cause hospitalization
Frequency of all-cause hospitalization.
Cardiovascular death
Time to cardiovascular death.
All-cause mortality
Time to all-cause mortality.

Full Information

First Posted
October 11, 2018
Last Updated
October 13, 2022
Sponsor
Tricida, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03710291
Brief Title
Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis
Acronym
VALOR-CKD
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Administrative reasons
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
August 23, 2022 (Actual)
Study Completion Date
September 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tricida, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Acidosis, Chronic Kidney Disease
Keywords
serum bicarbonate, renal outcomes, TRC101, eGFR, veverimer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRC101
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TRC101
Other Intervention Name(s)
Veverimer
Intervention Description
Oral, non-absorbed, polymeric hydrochloric acid binder
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Progression of chronic kidney disease
Description
Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death.
Time Frame
Through study completion, up to approximately 6 years.
Secondary Outcome Measure Information:
Title
Death (all-cause), ESRD or a confirmed ≥50% reduction in eGFR
Description
Time to first occurrence of: death (all-cause); ESRD; a confirmed ≥50% reduction in eGFR.
Time Frame
Through study completion, up to approximately 6 years.
Title
Physical functioning (subjective)
Description
Kidney Disease Quality of Life Physical Functioning Survey.
Time Frame
18 months after randomization.
Title
Physical functioning (objective)
Description
Repeated chair stand test.
Time Frame
18 months after randomization.
Title
ESRD or renal death
Description
Time to ESRD or renal death.
Time Frame
Through study completion, up to approximately 6 years.
Title
Primary outcome measure OR cardiovascular death
Description
Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death; cardiovascular death.
Time Frame
Through study completion, up to approximately 6 years.
Title
Serum creatinine
Description
Time to first occurrence of a confirmed doubling of serum creatinine.
Time Frame
Through study completion, up to approximately 6 years.
Title
≥50% reduction in eGFR
Description
Time to first occurrence of a confirmed ≥50% reduction in eGFR.
Time Frame
Through study completion, up to approximately 6 years.
Title
≥40% reduction in eGFR
Description
Time to first occurrence of a confirmed ≥40% reduction in eGFR.
Time Frame
Through study completion, up to approximately 6 years.
Title
All-cause hospitalization
Description
Frequency of all-cause hospitalization.
Time Frame
Through study completion, up to approximately 6 years.
Title
Cardiovascular death
Description
Time to cardiovascular death.
Time Frame
Through study completion, up to approximately 6 years.
Title
All-cause mortality
Description
Time to all-cause mortality.
Time Frame
Through study completion, up to approximately 6 years.
Other Pre-specified Outcome Measures:
Title
Safety of TRC101
Description
Frequency, intensity, and relationship to study drug of adverse events and serious adverse events.
Time Frame
Through study completion, up to approximately 6 years.

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34009141
Citation
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.
Results Reference
derived

Learn more about this trial

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

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