Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Metabolic Acidosis, Chronic Kidney Disease

In brief

The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.

Key facts

Study ID

NCT03710291

Run by

Tricida, Inc.

People needed

1480

Starts

2018-11-20

Expected to finish

2022-09-27

Last updated by the study team

2022-10-14

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Estimated glomerular filtration rate (eGFR) 20 - 40 mL/min/1.73m\^2.
• Serum bicarbonate 12 - 20 mEq/L.
• On maximum tolerated dose of ACE inhibitor and/or ARB.

You may not qualify if…

• Acute metabolic acidosis.
• Anticipated dialysis or kidney transplant within 6 months.
• Recent acute kidney injury.

Where it is running

• Investigative Site 4148 — Denver, Colorado, United States
• Investigative Site 4157 — Boca Raton, Florida, United States
• Investigative Site 4146 — Bradenton, Florida, United States
• Investigative Site 4102 — Coral Springs, Florida, United States
• Investigative Site 4153 — Fort Lauderdale, Florida, United States
• Investigative Site 4122 — Hollywood, Florida, United States
• Investigative Site 4123 — Hollywood, Florida, United States
• Investigative Site 4104 — Miami, Florida, United States
• Investigative Site 4130 — Miami Lakes, Florida, United States
• Investigative Site 4116 — Port Charlotte, Florida, United States
• Investigative Site 4152 — Tampa, Florida, United States
• Investigative Site 4127 — Augusta, Georgia, United States
• Investigative Site 4141 — Greenbelt, Maryland, United States
• Investigative Site 4155 — Kansas City, Missouri, United States
• Investigative Site 4108 — Greenville, North Carolina, United States
• Investigative Site 4106 — Kinston, North Carolina, United States
• Investigative Site 4107 — New Bern, North Carolina, United States
• Investigative Site 4124 — Bethlehem, Pennsylvania, United States
• Investigative Site 4132 — Nashville, Tennessee, United States
• Investigative Site 1103 — Shkoder, Albania
• Investigative Site 1101 — Tirana, Albania
• Investigative Site 4402 — Buenos Aires, Argentina
• Investigative Site 4410 — Corrientes, Argentina
• Investigative Site 4414 — Córdoba, Argentina
• Investigative Site 4136 — Azusa, California, United States

Full record on ClinicalTrials.gov

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