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
Protocol No: TRCA-303
Sponsor: Tricida, Inc.
Investigator: Kianoosh Kaveh, DO
You are being asked to volunteer to take part in a research study because you have kidney disease and a lower than normal level of bicarbonate in your blood. Kidney disease causes the kidneys to function less well and to retain acid in the blood causing a condition called “metabolic acidosis”. Blood that has too much acid can cause problems with bone, muscles, and other body functions. Low blood bicarbonate may also contribute to worsening of kidney function. When there is too much acid in the blood, the blood bicarbonate level goes down, below the normal range. Increasing the blood bicarbonate level makes the level of acid in the blood go down.
Purpose of this Study
This study is designed to learn:
If TRC101 (the drug being studied) can slow down the progression of kidney disease.
If TRC101 can lengthen the time until dialysis or a kidney transplant is needed.
If TRC101 can reduce the need for hospitalization.
If TRC101 can allow patients to live longer.
If TRC101 can reduce loss of bone and muscle and make patients function better.
About the safety of TRC101 in patients with kidney disease.
Costs of Participation Procedures, study drug and tests that are done only as part of this research study will be provided to you free of charge.
Tricida, Inc. will not pay for any non-study procedures or medications that you need while you are in the study. This would include any medications that are not part of the study. If you have any questions about what will be provided to you free of charge or what may result in a cost to you, please ask the Study Doctor or a member of the Study Staff.
If a commercial drug treatment or service is developed or any discoveries or inventions are made as a result of this study, the ownership and profits will belong to Tricida, Inc. There are no plans to provide payment to you should this occur.
Compensation You will receive $50 for each completed visit.