Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease

Metabolic Acidosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317444
• Other study ID #: TRCA-301
• Secondary ID: 2016-003825-41
• Status: Completed
• Phase: Phase 3
• Start date: September 26, 2017
• Est. completion date: May 15, 2018

Study information

• Verified date: March 2021
• Source: Tricida, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: May 15, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acidosis
• Kidney Diseases
• Metabolic Acidosis
• Renal Insufficiency, Chronic

Intervention

Drug:
• TRC101
Oral suspension
• Placebo
Oral suspension

Locations

Country	Name	City	State
Bulgaria	Investigative Site 11	Sofia
Croatia	Investigative Site 21	Zagreb
Georgia	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
Hungary	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	Hódmezovásárhely
Hungary	Investigative Site 44	Kistarcsa
Hungary	Investigative Site 42	Miskolc
Hungary	Investigative Site 47	Mosonmagyaróvár
Serbia	Investigative Site 64	Belgrade
Serbia	Investigative Site 65	Belgrade
Serbia	Investigative Site 61	Vršac
Serbia	Investigative Site 62	Zrenjanin
Slovenia	Investigative Site 72	Jesenice
Slovenia	Investigative Site 71	Maribor
Ukraine	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
United States	Investigative Site 95	Atlanta	Georgia
United States	Investigative Site 56	Chula Vista	California
United States	Investigative Site 58	Flushing	New York
United States	Investigative Site 59	Hialeah	Florida
United States	Investigative Site 54	Hollywood	Florida
United States	Investigative Site 93	Hollywood	Florida
United States	Investigative Site 92	Lauderdale Lakes	Florida
United States	Investigative Site 91	Los Angeles	California
United States	Investigative Site 55	Phoenix	Arizona
United States	Investigative Site 52	San Antonio	Texas
United States	Investigative Site 53	Shreveport	Louisiana
United States	Investigative Site 51	Tampa	Florida
United States	Investigative Site 57	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tricida, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Croatia,  Georgia,  Hungary,  Serbia,  Slovenia,  Ukraine, 

References & 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. La — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline to End of Treatment in Serum Bicarbonate	Mean change from baseline to end of treatment (Week 12 Visit) in serum bicarbonate	Baseline to Week 12