Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
2 other identifiers
interventional
217
8 countries
44
Brief Summary
This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily. The maximum study duration is anticipated to be up to 16 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2017
Shorter than P25 for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 2017
CompletedFirst Submitted
Initial submission to the registry
October 11, 2017
CompletedFirst Posted
Study publicly available on registry
October 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2018
CompletedResults Posted
Study results publicly available
April 26, 2021
CompletedApril 26, 2021
March 1, 2021
7 months
October 11, 2017
March 4, 2021
April 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
Composite endpoint of the percentage of subjects having a change from baseline in serum bicarbonate ≥ 4 mEq/L or having serum bicarbonate in the normal range (22 - 29 mEq/L) at the end of treatment (Week 12 Visit).
Baseline to Week 12
Secondary Outcomes (1)
Change From Baseline to End of Treatment in Serum Bicarbonate
Baseline to Week 12
Study Arms (2)
TRC101
EXPERIMENTALAdministered once daily (QD) for 12 weeks
Placebo
PLACEBO COMPARATORAdministered once daily (QD) for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Blood bicarbonate level of 12 to 20 mEq/L.
- 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.
You may not qualify if:
- Any level of low blood bicarbonate during the screening period that in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tricida, Inc.lead
Study Sites (44)
Investigative Site 55
Phoenix, Arizona, 85032, United States
Investigative Site 56
Chula Vista, California, 91910, United States
Investigative Site 91
Los Angeles, California, 90022, United States
Investigative Site 59
Hialeah, Florida, 33015, United States
Investigative Site 54
Hollywood, Florida, 33021, United States
Investigative Site 93
Hollywood, Florida, 33024, United States
Investigative Site 92
Lauderdale Lakes, Florida, 33313, United States
Investigative Site 51
Tampa, Florida, 33614, United States
Investigative Site 57
Winter Park, Florida, 32789, United States
Investigative Site 95
Atlanta, Georgia, 30342, United States
Investigative Site 53
Shreveport, Louisiana, 71101, United States
Investigative Site 58
Flushing, New York, 11355, United States
Investigative Site 52
San Antonio, Texas, 78215, 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
Related Publications (1)
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.
PMID: 30857647RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information
- Organization
- Tricida, Inc.
Study Officials
- STUDY DIRECTOR
Clinical Operations
Tricida, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2017
First Posted
October 23, 2017
Study Start
September 26, 2017
Primary Completion
May 4, 2018
Study Completion
May 15, 2018
Last Updated
April 26, 2021
Results First Posted
April 26, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share