Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
NCT ID: NCT03317444
Last Updated: 2021-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
217 participants
INTERVENTIONAL
2017-09-26
2018-05-15
Brief Summary
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The maximum study duration is anticipated to be up to 16 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TRC101
Administered once daily (QD) for 12 weeks
TRC101
Oral suspension
Placebo
Administered once daily (QD) for 12 weeks
Placebo
Oral suspension
Interventions
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TRC101
Oral suspension
Placebo
Oral suspension
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Estimated glomerular filtration rate (eGFR) of 20 to 40 mL/min/1.73m2.
* Stable kidney function defined as \<=20% variability in eGFR during screening period.
Exclusion Criteria
* Anuria, dialysis, acute kidney injury, or history of acute kidney insufficiency within 3 months prior to screening.
* Heart failure with maximum New York Heart Association (NYHA) Class IV symptoms or that required hospitalization during the preceding 6 months.
* Heart or kidney transplant.
* Chronic obstructive pulmonary disease (COPD) that is treated with chronic oral steroids, that requires the subject to be on oxygen, or that required hospitalization within the previous 6 months.
* Change in doses to alkali therapy in the 4 weeks prior to screening.
* History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, inflammatory bowel disease, major gastrointestinal surgery, frequent diarrhea or active gastric/duodenal ulcers.
* Serum calcium \<= 8.0 mg/dL at screening.
* Planned initiation of renal replacement therapy within 12 weeks following randomization.
* Use of polymeric binder drugs within 14 days prior to screening.
18 Years
85 Years
ALL
No
Sponsors
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Tricida, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Operations
Role: STUDY_DIRECTOR
Tricida, Inc.
Locations
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Investigative Site 55
Phoenix, Arizona, United States
Investigative Site 56
Chula Vista, California, United States
Investigative Site 91
Los Angeles, California, United States
Investigative Site 59
Hialeah, Florida, United States
Investigative Site 54
Hollywood, Florida, United States
Investigative Site 93
Hollywood, Florida, United States
Investigative Site 92
Lauderdale Lakes, Florida, United States
Investigative Site 51
Tampa, Florida, United States
Investigative Site 57
Winter Park, Florida, United States
Investigative Site 95
Atlanta, Georgia, United States
Investigative Site 53
Shreveport, Louisiana, United States
Investigative Site 58
Flushing, New York, United States
Investigative Site 52
San Antonio, Texas, United States
Investigative Site 11
Sofia, , Bulgaria
Investigative Site 21
Zagreb, , Croatia
Investigative Site 31
Tbilisi, , Georgia
Investigative Site 32
Tbilisi, , Georgia
Investigative Site 33
Tbilisi, , Georgia
Investigative Site 34
Tbilisi, , Georgia
Investigative Site 35
Tbilisi, , Georgia
Investigative Site 36
Tbilisi, , Georgia
Investigative Site 37
Tbilisi, , Georgia
Investigative Site 43
Baja, , Hungary
Investigative Site 48
Balatonfüred, , Hungary
Investigative Site 41
Budapest, , Hungary
Investigative Site 46
Budapest, , Hungary
Investigative Site 45
Hatvan, , Hungary
Investigative Site 49
Hódmezővásárhely, , Hungary
Investigative Site 44
Kistarcsa, , Hungary
Investigative Site 42
Miskolc, , Hungary
Investigative Site 47
Mosonmagyaróvár, , Hungary
Investigative Site 64
Belgrade, , Serbia
Investigative Site 65
Belgrade, , Serbia
Investigative Site 61
Vršac, , Serbia
Investigative Site 62
Zrenjanin, , Serbia
Investigative Site 72
Jesenice, , Slovenia
Investigative Site 71
Maribor, , Slovenia
Investigative Site 81
Kharkiv, , Ukraine
Investigative Site 83
Kharkiv, , Ukraine
Investigative Site 87
Kharkiv, , Ukraine
Investigative Site 88
Kharkiv, , Ukraine
Investigative Site 84
Kyiv, , Ukraine
Investigative Site 85
Kyiv, , Ukraine
Investigative Site 86
Kyiv, , Ukraine
Countries
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References
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Wesson DE, Mathur V, Tangri N, Stasiv Y, Parsell D, Li E, Klaerner G, Bushinsky DA. Veverimer versus placebo in patients with metabolic acidosis associated with chronic kidney disease: a multicentre, randomised, double-blind, controlled, phase 3 trial. Lancet. 2019 Apr 6;393(10179):1417-1427. doi: 10.1016/S0140-6736(18)32562-5. Epub 2019 Mar 8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003825-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TRCA-301
Identifier Type: -
Identifier Source: org_study_id
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