Status:
COMPLETED
Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
Lead Sponsor:
Tricida, Inc.
Conditions:
Metabolic Acidosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 meta...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
September 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2018
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT03317444
Start Date
September 26 2017
End Date
May 15 2018
Last Update
April 26 2021
Active Locations (44)
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1
Investigative Site 55
Phoenix, Arizona, United States, 85032
2
Investigative Site 56
Chula Vista, California, United States, 91910
3
Investigative Site 91
Los Angeles, California, United States, 90022
4
Investigative Site 59
Hialeah, Florida, United States, 33015