Long-term Safety Extension to Study TRCA-301

Status Completed

Clinical Trial Summary

This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03390842
Study type	Interventional
Source	Tricida, Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	December 20, 2017
Completion date	February 22, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04984226` - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD	Phase 2
Completed	`NCT03317444` - Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease	Phase 3
Recruiting	`NCT05582824` - Lactate Metabolism in the Hypoperfused Critically Ill
Active, not recruiting	`NCT04010630` - Sodium Bicarbonate for the Treatment of Severe Metabolic Acidosis With Moderate or Severe Acute Kidney Injury in ICU	N/A
Completed	`NCT02303548` - Bicarbonate in Patients With Out-of-hospital Cardiac Arrest	Phase 2
Recruiting	`NCT01860001` - Incidence of Postoperative Ketosis and Metabolic Acidosis	N/A
Completed	`NCT01452412` - Alkali Therapy in Chronic Kidney Disease	Phase 2/Phase 3
Terminated	`NCT03710291` - Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis	Phase 3
Completed	`NCT02476253` - Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill	Phase 3
Completed	`NCT05940935` - The Relationship of Developing Metabolic Acidosis With Antiepleptic Drugs in Craniotomy Operations
Withdrawn	`NCT03846258` - High Versus Low Bicarbonate Bath in Critically-ill Patients Receiving Continuous Renal Replacement Therapy	Phase 4
Completed	`NCT05970094` - Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5	N/A
Recruiting	`NCT05784389` - Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5	N/A
Terminated	`NCT04727528` - Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease	Phase 3
Completed	`NCT02098356` - Comparison of High Versus Low Bicarbonate Hemodialysis	N/A
Recruiting	`NCT03897101` - Inflammation and Metabolic Acidosis at Birth (AGAIN: AutophaGy AcIdosis Newborn)
Terminated	`NCT01894594` - Efficacy, Safety Study and Benefit of Alkali Therapy in Sickle Cell Disease	Phase 1
Completed	`NCT01075750` - Perioperative Fluid Management in Patients Receiving Cadaveric Renal Transplants	N/A
Completed	`NCT01295190` - Substitution of Propofol by Sevoflurane During Pediatric Cardiopulmonary Bypass	N/A
Completed	`NCT01293266` - Effect of Propofol and Sevoflurane on Lactate During Anesthesia for Pediatric Heart Catheterisation	N/A