Status:
COMPLETED
Long-term Safety Extension to Study TRCA-301
Lead Sponsor:
Tricida, Inc.
Conditions:
Metabolic Acidosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to partici...
Eligibility Criteria
Inclusion
- Key
- Completed the 12-week treatment period and attended the Week 12 Visit in the parent study TRCA-301.
- Blood bicarbonate level of \>= 12 mEq/L at the Week 12 Visit in the parent study TRCA-301.
- Key
Exclusion
- Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
- Required dialysis for acute kidney injury or worsening CKD during the parent study TRCA-301.
- Planned initiation of renal replacement therapy within 6 months following study entry.
- History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, severe gastrointestinal disorders, inflammatory bowel disease, major gastrointestinal surgery, or active gastric/duodenal ulcers.
- Serum calcium \<= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2019
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT03390842
Start Date
December 20 2017
End Date
February 22 2019
Last Update
October 22 2021
Active Locations (29)
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1
Investigative Site 55
Phoenix, Arizona, United States, 85032
2
Investigative Site 91
Los Angeles, California, United States, 90022
3
Investigative Site 59
Hialeah, Florida, United States, 33015
4
Investigative Site 93
Hollywood, Florida, United States, 33024