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

Last updated: October 13, 2022
Sponsor: Tricida, Inc.
Overall Status: Terminated

Phase

3

Condition

Arginase Deficiency

Nephropathy

Kidney Disease

Treatment

N/A

Clinical Study ID

NCT03710291
TRCA-303
2018-001303-36
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 1480
Study Start date:
November 20, 2018
Estimated Completion Date:
September 27, 2022

Study 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.

Connect with a study center

  • Investigative Site 1102

    Fier, 9300
    Albania

    Site Not Available

  • Investigative Site 1103

    Shkodër, 4001
    Albania

    Site Not Available

  • Investigative Site 1101

    Tirana, 1023
    Albania

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    Buenos Aires, B6000GMA
    Argentina

    Site Not Available

  • Investigative Site 4410

    Corrientes, W3400AMZ
    Argentina

    Site Not Available

  • Investigative Site 4408

    Córdoba, X5002AOQ
    Argentina

    Site Not Available

  • Investigative Site 4414

    Córdoba, X5000AAW
    Argentina

    Site Not Available

  • Investigative Site 4405

    Mar Del Plata, B7600FYK
    Argentina

    Site Not Available

  • Investigative Site 4409

    San Luis, D5700CGR
    Argentina

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  • Investigative Site 4403

    Santa Fe, S3000EPV
    Argentina

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  • Investigative Site 2802

    Yerevan, 0025
    Armenia

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  • Investigative Site 2803

    Yerevan, 0014
    Armenia

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  • Investigative Site 2805

    Yerevan, 0075
    Armenia

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    Yerevan, 0078
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    Yerevan, 0015
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    Yerevan, 0052
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    Benowa, 4217
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    Clayton, 3168
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    Fitzroy, 3065
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    Gosford, 2250
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    New Lambton Heights, 2305
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    Parkville, 3052
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    Gomel, 246029
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    Grodno, 230017
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    Minsk, 223041
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    Vitebsk, 210037
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    Antwerpen, 2820
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    Brussels, 1070
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    Gent, 9000
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    Brasília, 71625-175
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    Caxias Do Sul, 95010-005
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    Curitiba, 80440-020
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    Curitiba, 80060-150
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    Fortaleza, 60430-270
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    Juiz De Fora, 36036-330
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    Porto Alegre, 90610-000
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    São Paulo, 15090-000
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    São Paulo, 09090-790
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    São Paulo, 09715-090
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    São Paulo, 18618-686
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    Votuporanga, 15500-003
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    Kozloduy, 3320
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    Montana, 3400
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    Pleven, 5800
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    Ruse, 7000
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    Ruse, 7000
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    Sevlievo, 5400
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    Sliven, 8800
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    Stara Zagora, 6100
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    Yambol, 8600
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    Kitchener, N2H 5Z8
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    Cartagena, 130010
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    Pardubice, 532 03
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    Praha, 128 08
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    Slaný, 274 01
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    Sokolov, 356 01
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    Znojmo, 669 03
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    Annonay, 07100
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    Boulogne-Billancourt, 92100
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    Batumi, 6010
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    Kutaisi, 4600
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    Tbilisi, 0159
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    Tbilisi, 0112
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    Tbilisi, 0159
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    Tbilisi, 0159
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    Tbilisi, 0102
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    Tbilisi, 0186
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    Tbilisi, 0159
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    Sha Tin,
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    Pécs, 7624
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    Szekszárd, 7100
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    Szombathely, 9700
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    Tiberias, 1528001
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    Zerifin, 7030000
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    Bologna, 40138
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    Reggio Calabria, 89124
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    Bucheon, 14647
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    Cheonan, 31151
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    Seoul, 05030
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    Alor Setar, 05460
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    Klang, 41200
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    Kota Bharu, 16150
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    Kuala Lumpur, 59100
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    Kuantan, 25100
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    Kulim, 09000
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    Pulau Pinang, 10450
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    Delegación Tlalpan, 14080
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    Guadalajara, 44600
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    Guadalajara, 44130
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    Guadalajara, 44620
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    Mexico City, 06700
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    Mexico City, 06100
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    Mexico City, 04100
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    Monterrey, 64310
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    Morelia, 58249
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    Morelia, 58260
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    Mérida, 97130
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    Mérida, 97000
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    Amsterdam, 1105 AZ
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    Apeldoorn, 7334
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    Breda, 4818 CK
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    Groningen, 2713
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    Shtip, 2000
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    Skopje, 1000
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    Skopje, 1000
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    Struga, 6330
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    Gdańsk, 80-952
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    Gdynia, 81-157
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    Katowice, 40-027
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    Aveiro, 3814-501
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    Lisboa, 2674-514
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    Lisboa, 2790-134
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    Porto, 4099-001
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    Torres Novas, 2350-754
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    Vila Nova De Gaia, 4400-129
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    Bucharest, 012071
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    Craiova, 200642
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    Deva, 330025
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    Oradea, 410469
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    Satu Mare, 440192
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    Timişoara, 300723
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    Belgrad, 11000
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    Belgrade, 11000
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    Kragujevac, 34000
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    Krusevac, 37000
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    Niš, 18000
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    Novi Sad, 21000
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    Užice, 31000
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    Vršac, 26300
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    Zaječar, 19000
    Serbia

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    Singapore, 119074
    Singapore

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    Singapore, 169856
    Singapore

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    Singapore, 529889
    Singapore

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    Bratislava, 82606
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    Hlohovec, 920 01
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    Košice, 04001
    Slovakia

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    Košice, 04011
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    Svidník, 08901
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    Almería, 04003
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    Barcelona, 25198
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    Barcelona, 08907
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    Barcelona, 08036
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    Bilbao, 48013
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    Girona, 17007
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    La Coruña, 15405
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    Lugo, 27880
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    Sevilla, 41009
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    Valencia, 46014
    Spain

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    Zaragoza, 50009
    Spain

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    Changhua, 50006
    Taiwan

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    Hualien City, 97002
    Taiwan

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  • Investigative Site 6501

    Kaohsiung, 81362
    Taiwan

    Site Not Available

  • Investigative Site 6504

    New Taipei City, 220
    Taiwan

    Site Not Available

  • Investigative Site 6506

    Taichung, 40201
    Taiwan

    Site Not Available

  • Investigative Site 6507

    Taichung, 433
    Taiwan

    Site Not Available

  • Investigative Site 6510

    Taichung, 40447
    Taiwan

    Site Not Available

  • Investigative Site 6503

    Tainan, 71004
    Taiwan

    Site Not Available

  • Investigative Site 6509

    Taipei, 10002
    Taiwan

    Site Not Available

  • Investigative Site 6511

    Taipei, 11031
    Taiwan

    Site Not Available

  • Investigative Site 2712

    Dnipro, 49102
    Ukraine

    Site Not Available

  • Investigative Site 2714

    Ivano-Frankivs'k, 76018
    Ukraine

    Site Not Available

  • Investigative Site 2704

    Kharkiv, 61103
    Ukraine

    Site Not Available

  • Investigative Site 2707

    Kharkiv, 61106
    Ukraine

    Site Not Available

  • Investigative Site 2713

    Kharkiv, 61039
    Ukraine

    Site Not Available

  • Investigative Site 2717

    Kharkiv, 61002
    Ukraine

    Site Not Available

  • Investigative Site 2721

    Kharkiv, 61039
    Ukraine

    Site Not Available

  • Investigative Site 2703

    Kyiv, 02125
    Ukraine

    Site Not Available

  • Investigative Site 2705

    Kyiv, 04050
    Ukraine

    Site Not Available

  • Investigative Site 2706

    Kyiv, 01601
    Ukraine

    Site Not Available

  • Investigative Site 2709

    Kyiv, 03680
    Ukraine

    Site Not Available

  • Investigative Site 2710

    Kyiv, 04114
    Ukraine

    Site Not Available

  • Investigative Site 2716

    Kyiv, 04114
    Ukraine

    Site Not Available

  • Investigative Site 2708

    Odesa, 65025
    Ukraine

    Site Not Available

  • Investigative Site 2718

    Ternopil', 46002
    Ukraine

    Site Not Available

  • Investigative Site 2719

    Zaporizhzhya, 69600
    Ukraine

    Site Not Available

  • Investigative Site 2715

    Zhytomyr, 10002
    Ukraine

    Site Not Available

  • Investigative Site 3814

    Belfast, BT9 7AB
    United Kingdom

    Site Not Available

  • Investigative Site 3815

    Coventry, CV2 2DX
    United Kingdom

    Site Not Available

  • Investigative Site 3816

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Investigative Site 3802

    Leicester, LE5 4PW
    United Kingdom

    Site Not Available

  • Investigative Site 3805

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Investigative Site 3804

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Investigative Site 3810

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Investigative Site 3811

    Preston, PR2 9HT
    United Kingdom

    Site Not Available

  • Investigative Site 3801

    Swansea, SA6 6NL
    United Kingdom

    Site Not Available

  • Investigative Site 3809

    York, YO31 8HE
    United Kingdom

    Site Not Available

  • Investigative Site 4121

    Mesa, Arizona 85210
    United States

    Site Not Available

  • Investigative Site 4136

    Azusa, California 91702
    United States

    Site Not Available

  • Investigative Site 4109

    Bakersfield, California 93309
    United States

    Site Not Available

  • Investigative Site 4113

    Sacramento, California 95825
    United States

    Site Not Available

  • Investigative Site 4119

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Investigative Site 4148

    Denver, Colorado 80230
    United States

    Site Not Available

  • Investigative Site 4120

    Stamford, Connecticut 06902
    United States

    Site Not Available

  • Investigative Site 4157

    Boca Raton, Florida 33431
    United States

    Site Not Available

  • Investigative Site 4146

    Bradenton, Florida 34209
    United States

    Site Not Available

  • Investigative Site 4102

    Coral Springs, Florida 33071
    United States

    Site Not Available

  • Investigative Site 4153

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Investigative Site 4122

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Investigative Site 4123

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Investigative Site 4133

    Lauderdale Lakes, Florida 33313
    United States

    Site Not Available

  • Investigative Site 4104

    Miami, Florida 33015
    United States

    Site Not Available

  • Investigative Site 4144

    Miami Gardens, Florida 33169
    United States

    Site Not Available

  • Investigative Site 4130

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Investigative Site 4116

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Investigative Site 4152

    Tampa, Florida 33637
    United States

    Site Not Available

  • Investigative Site 4127

    Augusta, Georgia 30904
    United States

    Site Not Available

  • Investigative Site 4141

    Greenbelt, Maryland 20770
    United States

    Site Not Available

  • Investigative Site 4155

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Investigative Site 4140

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Investigative Site 4125

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Investigative Site 4108

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Investigative Site 4106

    Kinston, North Carolina 28504
    United States

    Site Not Available

  • Investigative Site 4107

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • Investigative Site 4135

    Cincinnati, Ohio 45206
    United States

    Site Not Available

  • Investigative Site 4124

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

  • Investigative Site 4128

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Investigative Site 4143

    Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • Investigative Site 4112

    Chattanooga, Tennessee 37408
    United States

    Site Not Available

  • Investigative Site 4137

    Knoxville, Tennessee 37923
    United States

    Site Not Available

  • Investigative Site 4132

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Investigative Site 4142

    Katy, Texas 77494
    United States

    Site Not Available

  • Investigative Site 4134

    San Antonio, Texas 78207
    United States

    Site Not Available

  • Investigative Site 4131

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Investigative Site 4111

    Saint George, Utah 84790
    United States

    Site Not Available

  • Investigative Site 4105

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Investigative Site 4101

    Tacoma, Washington 98405
    United States

    Site Not Available

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