Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis
- Conditions
- Chronic Kidney DiseaseMetabolic Acidosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT03710291
- Lead Sponsor
- Tricida, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1480
- 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.
- Acute metabolic acidosis.
- Anticipated dialysis or kidney transplant within 6 months.
- Recent acute kidney injury.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - TRC101 TRC101 -
- Primary Outcome Measures
Name Time Method Progression of chronic kidney disease Through study completion, up to approximately 6 years. Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death.
- Secondary Outcome Measures
Name Time Method Death (all-cause), ESRD or a confirmed ≥50% reduction in eGFR Through study completion, up to approximately 6 years. Time to first occurrence of: death (all-cause); ESRD; a confirmed ≥50% reduction in eGFR.
Cardiovascular death Through study completion, up to approximately 6 years. Time to cardiovascular death.
≥40% reduction in eGFR Through study completion, up to approximately 6 years. Time to first occurrence of a confirmed ≥40% reduction in eGFR.
Serum creatinine Through study completion, up to approximately 6 years. Time to first occurrence of a confirmed doubling of serum creatinine.
≥50% reduction in eGFR Through study completion, up to approximately 6 years. Time to first occurrence of a confirmed ≥50% reduction in eGFR.
Physical functioning (objective) 18 months after randomization. Repeated chair stand test.
ESRD or renal death Through study completion, up to approximately 6 years. Time to ESRD or renal death.
Primary outcome measure OR cardiovascular death Through study completion, up to approximately 6 years. Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death; cardiovascular death.
Physical functioning (subjective) 18 months after randomization. Kidney Disease Quality of Life Physical Functioning Survey.
All-cause hospitalization Through study completion, up to approximately 6 years. Frequency of all-cause hospitalization.
All-cause mortality Through study completion, up to approximately 6 years. Time to all-cause mortality.
Trial Locations
- Locations (203)
Investigative Site 2606
🇸🇰Košice, Slovakia
Investigative Site 2603
🇸🇰Svidník, Slovakia
Investigative Site 4122
🇺🇸Hollywood, Florida, United States
Investigative Site 4123
🇺🇸Hollywood, Florida, United States
Investigative Site 4116
🇺🇸Port Charlotte, Florida, United States
Investigative Site 4127
🇺🇸Augusta, Georgia, United States
Investigative Site 4108
🇺🇸Greenville, North Carolina, United States
Investigative Site 4106
🇺🇸Kinston, North Carolina, United States
Investigative Site 3804
🇬🇧Nottingham, United Kingdom
Investigative Site 4107
🇺🇸New Bern, North Carolina, United States
Investigative Site 4414
🇦🇷Córdoba, Argentina
Investigative Site 5101
🇦🇺Gosford, Australia
Investigative Site 1213
🇧🇬Montana, Bulgaria
Investigative Site 1210
🇧🇬Pleven, Bulgaria
Investigative Site 1205
🇧🇬Ruse, Bulgaria
Investigative Site 4203
🇨🇦Brampton, Canada
Investigative Site 3205
🇫🇷Lille, France
Investigative Site 2208
🇬🇪Tbilisi, Georgia
Investigative Site 2211
🇬🇪Tbilisi, Georgia
Investigative Site 2212
🇬🇪Tbilisi, Georgia
Investigative Site 2209
🇬🇪Tbilisi, Georgia
Investigative Site 2213
🇬🇪Tbilisi, Georgia
Investigative Site 3905
🇮🇱Jerusalem, Israel
Investigative Site 3716
🇪🇸Barcelona, Spain
Investigative Site 3707
🇪🇸Barcelona, Spain
Investigative Site 2713
🇺🇦Kharkiv, Ukraine
Investigative Site 4148
🇺🇸Denver, Colorado, United States
Investigative Site 4132
🇺🇸Nashville, Tennessee, United States
Investigative Site 4104
🇺🇸Miami, Florida, United States
Investigative Site 4408
🇦🇷Córdoba, Argentina
Investigative Site 4136
🇺🇸Azusa, California, United States
Investigative Site 4157
🇺🇸Boca Raton, Florida, United States
Investigative Site 4146
🇺🇸Bradenton, Florida, United States
Investigative Site 4102
🇺🇸Coral Springs, Florida, United States
Investigative Site 4153
🇺🇸Fort Lauderdale, Florida, United States
Investigative Site 4152
🇺🇸Tampa, Florida, United States
Investigative Site 4130
🇺🇸Miami Lakes, Florida, United States
Investigative Site 4141
🇺🇸Greenbelt, Maryland, United States
Investigative Site 4124
🇺🇸Bethlehem, Pennsylvania, United States
Investigative Site 1103
🇦🇱Shkodër, Albania
Investigative Site 1101
🇦🇱Tirana, Albania
Investigative Site 4402
🇦🇷Buenos Aires, Argentina
Investigative Site 4410
🇦🇷Corrientes, Argentina
Investigative Site 2803
🇦🇲Yerevan, Armenia
Investigative Site 4405
🇦🇷Mar Del Plata, Argentina
Investigative Site 4409
🇦🇷San Luis, Argentina
Investigative Site 2809
🇦🇲Yerevan, Armenia
Investigative site 2801
🇦🇲Yerevan, Armenia
Investigative Site 2802
🇦🇲Yerevan, Armenia
Investigative Site 2805
🇦🇲Yerevan, Armenia
Investigative Site 3103
🇧🇪Liège, Belgium
Investigative Site 2807
🇦🇲Yerevan, Armenia
Investigative Site 1502
🇧🇾Grodno, Belarus
Investigative Site 3108
🇧🇪Liège, Belgium
Investigative Site 4518
🇧🇷Caxias Do Sul, Brazil
Investigative Site 4516
🇧🇷Curitiba, Brazil
Investigative Site 4504
🇧🇷Curitiba, Brazil
Investigative Site 4517
🇧🇷São Paulo, Brazil
Investigative Site 4507
🇧🇷Juiz De Fora, Brazil
Investigative Site 4508
🇧🇷São Paulo, Brazil
Investigative Site 4509
🇧🇷São Paulo, Brazil
Investigative Site 4506
🇧🇷São Paulo, Brazil
Investigative Site 4519
🇧🇷São Paulo, Brazil
Investigative Site 1211
🇧🇬Kozloduy, Bulgaria
Investigative Site 1206
🇧🇬Sevlievo, Bulgaria
Investigative Site 1212
🇧🇬Ruse, Bulgaria
Investigative Site 1204
🇧🇬Sliven, Bulgaria
Investigative Site 1201
🇧🇬Sofia, Bulgaria
Investigative Site 1208
🇧🇬Veliko Tarnovo, Bulgaria
Investigative Site 1203
🇧🇬Yambol, Bulgaria
Investigative Site 4202
🇨🇦Kitchener, Canada
Investigative Site 4204
🇨🇦Québec, Canada
Investigative Site 4201
🇨🇦London, Canada
Investigative Site 4601
🇨🇱Providencia, Chile
Investigative Site 4208
🇨🇦Winnipeg, Canada
Investigative Site 4604
🇨🇱Concepción, Chile
Investigative Site 4602
🇨🇱Temuco, Chile
Investigative Site 4703
🇨🇴Barranquilla, Colombia
Investigative Site 4708
🇨🇴Barranquilla, Colombia
Investigative Site 4712
🇨🇴Barranquilla, Colombia
Investigative Site 4705
🇨🇴Cali, Colombia
Investigative Site 4709
🇨🇴Zipaquirá, Colombia
Investigative Site 2201
🇬🇪Batumi, Georgia
Investigative Site 3209
🇫🇷Boulogne-Billancourt, France
Investigative Site 2106
🇨🇿Sokolov, Czechia
Investigative Site 2107
🇨🇿Znojmo, Czechia
Investigative Site 2205
🇬🇪Tbilisi, Georgia
Investigative Site 2202
🇬🇪Kutaisi, Georgia
Investigative Site 2207
🇬🇪Tbilisi, Georgia
Investigative Site 2204
🇬🇪Tbilisi, Georgia
Investigative Site 2206
🇬🇪Tbilisi, Georgia
Investigative Site 2214
🇬🇪Tbilisi, Georgia
Investigative Site 2210
🇬🇪Tbilisi, Georgia
Investigative Site 6101
🇭🇰Hong Kong, Hong Kong
Investigative Site 2312
🇭🇺Budapest, Hungary
Investigative Site 2309
🇭🇺Kaposvár, Hungary
Investigative Site 2311
🇭🇺Baja, Hungary
Investigative Site 2304
🇭🇺Budapest, Hungary
Investigative Site 2306
🇭🇺Győr, Hungary
Investigative Site 2310
🇭🇺Kistarcsa, Hungary
Investigative Site 2316
🇭🇺Nagykanizsa, Hungary
Investigative Site 3913
🇮🇱Afula, Israel
Investigative Site 3911
🇮🇱Tel Aviv, Israel
Investigative Site 3902
🇮🇱Ashkelon, Israel
Investigative Site 3408
🇮🇹Genova, Italy
Investigative Site 3903
🇮🇱Tiberias, Israel
Investigative Site 3407
🇮🇹Messina, Italy
Investigative Site 3405
🇮🇹Milano, Italy
Investigative Site 3406
🇮🇹Napoli, Italy
Investigative Site 3402
🇮🇹Pavia, Italy
Investigative Site 3409
🇮🇹Reggio Calabria, Italy
Investigative Site 5207
🇰🇷Ansan, Korea, Republic of
Investigative Site 5205
🇰🇷Goyang, Korea, Republic of
Investigative Site 5218
🇰🇷Cheonan, Korea, Republic of
Investigative Site 5203
🇰🇷Anyang, Korea, Republic of
Investigative Site 5204
🇰🇷Daejeon, Korea, Republic of
Investigative Site 5215
🇰🇷Guri-si, Korea, Republic of
Investigative Site 5213
🇰🇷Seoul, Korea, Republic of
Investigative Site 5208
🇰🇷Seoul, Korea, Republic of
Investigative Site 6208
🇲🇾Klang, Malaysia
Investigative Site 5212
🇰🇷Wŏnju, Korea, Republic of
Investigative Site 6203
🇲🇾Kota Bharu, Malaysia
Investigative Site 6202
🇲🇾Kuala Lumpur, Malaysia
Investigative Site 6207
🇲🇾Kota Bharu, Malaysia
Investigative Site 6205
🇲🇾Kulim, Malaysia
Investigative Site 6204
🇲🇾Kuantan, Malaysia
Investigative Site 6210
🇲🇾Pulau Pinang, Malaysia
Investigative Site 6206
🇲🇾Seri Manjung, Malaysia
Investigative Site 6201
🇲🇾Sungai Petani, Malaysia
Investigative Site 4307
🇲🇽Cuernavaca, Mexico
Investigative Site 4313
🇲🇽Guadalajara, Mexico
Investigative Site 4304
🇲🇽Guadalajara, Mexico
Investigative Site 4311
🇲🇽Mexico City, Mexico
Investigative Site 4325
🇲🇽Mexico City, Mexico
Investigative Site 4319
🇲🇽Guadalajara, Mexico
Investigative Site 1412
🇷🇴Oradea, Romania
Investigative Site 4302
🇲🇽Mexico City, Mexico
Investigative Site 4320
🇲🇽Monterrey, Mexico
Investigative Site 4315
🇲🇽Morelia, Mexico
Investigative Site 4324
🇲🇽Morelia, Mexico
Investigative Site 2510
🇷🇸Krusevac, Serbia
Investigative Site 4316
🇲🇽Mérida, Mexico
Investigative Site 4301
🇲🇽Mérida, Mexico
Investigative Site 4310
🇲🇽Veracruz, Mexico
Investigative Site 4312
🇲🇽Zapopan, Mexico
Investigative Site 4305
🇲🇽Xalapa, Mexico
Investigative Site 3507
🇳🇱Alkmaar, Netherlands
Investigative Site 3505
🇳🇱Amersfoort, Netherlands
Investigative Site 3503
🇳🇱Groningen, Netherlands
Investigative Site 1305
🇲🇰Shtip, North Macedonia
Investigative Site 1304
🇲🇰Bitola, North Macedonia
Investigative Site 1301
🇲🇰Skopje, North Macedonia
Investigative Site 1303
🇲🇰Skopje, North Macedonia
Investigative Site 1302
🇲🇰Struga, North Macedonia
Investigative Site 2421
🇵🇱Kraków, Poland
Investigative Site 2414
🇵🇱Warsaw, Poland
Investigative Site 2412
🇵🇱Zabrze, Poland
Investigative Site 3605
🇵🇹Vila Nova De Gaia, Portugal
Investigative Site 3603
🇵🇹Lisboa, Portugal
Investigative Site 3607
🇵🇹Lisboa, Portugal
Investigative Site 3604
🇵🇹Aveiro, Portugal
Investigative Site 2505
🇷🇸Niš, Serbia
Investigative Site 2501
🇷🇸Belgrade, Serbia
Investigative Site 2508
🇷🇸Kragujevac, Serbia
Investigative Site 2514
🇷🇸Užice, Serbia
Investigative Site 2503
🇷🇸Vršac, Serbia
Investigative Site 2511
🇷🇸Zaječar, Serbia
Investigative Site 6401
🇸🇬Singapore, Singapore
Investigative Site 6403
🇸🇬Singapore, Singapore
Investigative Site 6404
🇸🇬Singapore, Singapore
Investigative Site 2604
🇸🇰Košice, Slovakia
Investigative Site 3706
🇪🇸Barcelona, Spain
Investigative Site 6502
🇨🇳Hualien City, Taiwan
Investigative Site 6501
🇨🇳Kaohsiung, Taiwan
Investigative Site 6504
🇨🇳New Taipei City, Taiwan
Investigative Site 6510
🇨🇳Taichung, Taiwan
Investigative Site 6503
🇨🇳Tainan, Taiwan
Investigative Site 6507
🇨🇳Taichung, Taiwan
Investigative Site 6506
🇨🇳Taichung, Taiwan
Investigative Site 6509
🇨🇳Taipei, Taiwan
Investigative Site 6511
🇨🇳Taipei, Taiwan
Investigative Site 2712
🇺🇦Dnipro, Ukraine
Investigative Site 2721
🇺🇦Kharkiv, Ukraine
Investigative Site 2714
🇺🇦Ivano-Frankivs'k, Ukraine
Investigative Site 2717
🇺🇦Kharkiv, Ukraine
Investigative Site 2704
🇺🇦Kharkiv, Ukraine
Investigative Site 2707
🇺🇦Kharkiv, Ukraine
Investigative Site 2706
🇺🇦Kyiv, Ukraine
Investigative Site 2703
🇺🇦Kyiv, Ukraine
Investigative Site 2709
🇺🇦Kyiv, Ukraine
Investigative Site 2710
🇺🇦Kyiv, Ukraine
Investigative Site 2716
🇺🇦Kyiv, Ukraine
Investigative Site 2718
🇺🇦Ternopil', Ukraine
Investigative Site 2705
🇺🇦Kyiv, Ukraine
Investigative Site 2719
🇺🇦Zaporizhzhya, Ukraine
Investigative Site 2715
🇺🇦Zhytomyr, Ukraine
Investigative Site 3815
🇬🇧Coventry, United Kingdom
Investigative Site 3801
🇬🇧Swansea, United Kingdom
Investigative Site 4155
🇺🇸Kansas City, Missouri, United States
Investigative Site 6512
🇨🇳Changhua, Taiwan
Investigative Site 6103
🇭🇰Hong Kong, Hong Kong
Investigative Site 6104
🇭🇰Sha Tin, Hong Kong
Investigative Site 6105
🇭🇰Hong Kong, Hong Kong