Clinical trial NCT03317444: Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolic Acidosis
Keywords: blood bicarbonate, kidney disease
Lead sponsor: Tricida, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-23
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change From Baseline to End of Treatment in Serum Bicarbonate
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigative Site 55
state: Arizona
city: Chula Vista
country: United States
facility: Investigative Site 56
state: California
city: Los Angeles
country: United States
facility: Investigative Site 91
state: California
city: Hialeah
country: United States
facility: Investigative Site 59
state: Florida
city: Hollywood
country: United States
facility: Investigative Site 54
state: Florida
city: Hollywood
country: United States
facility: Investigative Site 93
state: Florida
city: Lauderdale Lakes
country: United States
facility: Investigative Site 92
state: Florida
city: Tampa
country: United States
facility: Investigative Site 51
state: Florida
city: Winter Park
country: United States
facility: Investigative Site 57
state: Florida
city: Atlanta
country: United States
facility: Investigative Site 95
state: Georgia
city: Shreveport
country: United States
facility: Investigative Site 53
state: Louisiana
city: Flushing
country: United States
facility: Investigative Site 58
state: New York
city: San Antonio
country: United States
facility: Investigative Site 52
state: Texas
city: Sofia
country: Bulgaria
facility: Investigative Site 11
city: Zagreb
country: Croatia
facility: Investigative Site 21
city: Tbilisi
country: Georgia
facility: Investigative Site 31
city: Tbilisi
country: Georgia
facility: Investigative Site 32
city: Tbilisi
country: Georgia
facility: Investigative Site 33
city: Tbilisi
country: Georgia
facility: Investigative Site 34
city: Tbilisi
country: Georgia
facility: Investigative Site 35
city: Tbilisi
country: Georgia
facility: Investigative Site 36
city: Tbilisi
country: Georgia
facility: Investigative Site 37
city: Baja
country: Hungary
facility: Investigative Site 43
city: Balatonfüred
country: Hungary
facility: Investigative Site 48
city: Budapest
country: Hungary
facility: Investigative Site 41
city: Budapest
country: Hungary
facility: Investigative Site 46
city: Hatvan
country: Hungary
facility: Investigative Site 45
city: Hódmezővásárhely
country: Hungary
facility: Investigative Site 49
city: Kistarcsa
country: Hungary
facility: Investigative Site 44
city: Miskolc
country: Hungary
facility: Investigative Site 42
city: Mosonmagyaróvár
country: Hungary
facility: Investigative Site 47
city: Belgrade
country: Serbia
facility: Investigative Site 64
city: Belgrade
country: Serbia
facility: Investigative Site 65
city: Vršac
country: Serbia
facility: Investigative Site 61
city: Zrenjanin
country: Serbia
facility: Investigative Site 62
city: Jesenice
country: Slovenia
facility: Investigative Site 72
city: Maribor
country: Slovenia
facility: Investigative Site 71
city: Kharkiv
country: Ukraine
facility: Investigative Site 81
city: Kharkiv
country: Ukraine
facility: Investigative Site 83
city: Kharkiv
country: Ukraine
facility: Investigative Site 87
city: Kharkiv
country: Ukraine
facility: Investigative Site 88
city: Kyiv
country: Ukraine
facility: Investigative Site 84
city: Kyiv
country: Ukraine
facility: Investigative Site 85
city: Kyiv
country: Ukraine
facility: Investigative Site 86
Study officials:
affiliation: Tricida, Inc.
name: Clinical Operations
role: STUDY_DIRECTOR
References:
citation: 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.