Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
- Registration Number
- NCT03317444
- Lead Sponsor
- Tricida, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 217
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Administered once daily (QD) for 12 weeks TRC101 TRC101 Administered once daily (QD) for 12 weeks
- Primary Outcome Measures
Name Time Method Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range Baseline to Week 12 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).
- Secondary Outcome Measures
Name Time Method Change From Baseline to End of Treatment in Serum Bicarbonate Baseline to Week 12 Mean change from baseline to end of treatment (Week 12 Visit) in serum bicarbonate
Trial Locations
- Locations (44)
Investigative Site 32
🇬🇪Tbilisi, Georgia
Investigative Site 33
🇬🇪Tbilisi, Georgia
Investigative Site 36
🇬🇪Tbilisi, Georgia
Investigative Site 83
🇺🇦Kharkiv, Ukraine
Investigative Site 84
🇺🇦Kyiv, Ukraine
Investigative Site 65
🇷🇸Belgrade, Serbia
Investigative Site 61
🇷🇸Vršac, Serbia
Investigative Site 72
🇸🇮Jesenice, Slovenia
Investigative Site 62
🇷🇸Zrenjanin, Serbia
Investigative Site 81
🇺🇦Kharkiv, Ukraine
Investigative Site 91
🇺🇸Los Angeles, California, United States
Investigative Site 54
🇺🇸Hollywood, Florida, United States
Investigative Site 93
🇺🇸Hollywood, Florida, United States
Investigative Site 53
🇺🇸Shreveport, Louisiana, United States
Investigative Site 56
🇺🇸Chula Vista, California, United States
Investigative Site 11
🇧🇬Sofia, Bulgaria
Investigative Site 59
🇺🇸Hialeah, Florida, United States
Investigative Site 95
🇺🇸Atlanta, Georgia, United States
Investigative Site 57
🇺🇸Winter Park, Florida, United States
Investigative Site 58
🇺🇸Flushing, New York, United States
Investigative Site 21
🇭🇷Zagreb, Croatia
Investigative Site 31
🇬🇪Tbilisi, Georgia
Investigative Site 34
🇬🇪Tbilisi, Georgia
Investigative Site 35
🇬🇪Tbilisi, Georgia
Investigative Site 37
🇬🇪Tbilisi, Georgia
Investigative Site 48
🇭🇺Balatonfüred, Hungary
Investigative Site 43
🇭🇺Baja, Hungary
Investigative Site 41
🇭🇺Budapest, Hungary
Investigative Site 46
🇭🇺Budapest, 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 71
🇸🇮Maribor, Slovenia
Investigative Site 87
🇺🇦Kharkiv, Ukraine
Investigative Site 85
🇺🇦Kyiv, Ukraine
Investigative Site 88
🇺🇦Kharkiv, Ukraine
Investigative Site 86
🇺🇦Kyiv, Ukraine
Investigative Site 45
🇭🇺Hatvan, Hungary
Investigative Site 92
🇺🇸Lauderdale Lakes, Florida, United States
Investigative Site 51
🇺🇸Tampa, Florida, United States
Investigative Site 55
🇺🇸Phoenix, Arizona, United States
Investigative Site 52
🇺🇸San Antonio, Texas, United States