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A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis

Study category: Kidney Disease & Hypertension

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Description

This study will compare how well the study drug works in slowing the progression of kidney disease and how safe the study drug is when compared to placebo in chronic kidney disease patients with metabolic acidosis. The average duration of the study is anticipated to be about 3.5 years.

Details
Age

Adult

Eligibility

Male and female subjects between 18 - 85, inclusive GFR between 20 and 40 ml/min/1.73 m2, inclusive Serum Bicarbonate between 12 and 20 mEq/L, inclusive Systolic blood pressure <160/92

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Outcomes Research

Locations

Colorado Research Center
Renal Research Center

Principal Investigator
Jessica Kendrick,  MD

Jessica Kendrick, MD

Study ID

Protocol Number: 18-1795

ClinicalTrials.gov: NCT03710291

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