Metabolic acidosis associated with Chronic Kidney Disease MedDRA version: 20.0 Level: PT Classification code 10027417 Term: Metabolic acidosis System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Tricida, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Have provided written informed consent prior to participation in the study. 2.Have completed the 12-week treatment period and attended the Week 12 Visit in the parent study TRCA-301. 3.Have a blood bicarbonate value of = 12 mEq/L at the Week 12 Visit in Study TRCA-301, based on onsite measurement using the i-STAT point-of-care device. 4.Have adequate peripheral venous access for blood draws. 5.Women who are of childbearing potential must have negative pregnancy test at the Week 12 Visit and be willing to use an acceptable method of birth control until 1 month after study completion. Acceptable methods include hormonal contraception (oral contraceptives, patch, implant, and injection), intrauterine devices, double barrier methods (e.g., vaginal diaphragm, vaginal sponge, condom, spermicidal jelly), sexual abstinence or a vasectomized partner. Women who are surgically sterile with documentation of such, or who are at least 1-year post-last menstrual period and > 55 years of age, are considered not to be of childbearing potential. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 105
Exclusion criteria
Exclusion criteria: 1.Have any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process. 2.Required dialysis for acute kidney injury or worsening CKD during the parent study TRCA-301. 3.Planned initiation of renal replacement therapy (dialysis or transplantation) within 6 months following study entry. 4.Have a history or current diagnosis of clinically significant diabetic gastroparesis (based on Investigator’s judgment) or a history of bariatric surgery. 5.Have a history or current diagnosis of bowel obstruction, swallowing disorders, severe gastrointestinal (GI) disorders, inflammatory bowel disease, major GI surgery, or active gastric/duodenal ulcers. 6.Have a serum calcium = 8.0 mg/dL at the Week 10 Visit in the parent study, TRCA-301. 7.Have active cancer during the 1 year prior to the Week 12 Visit, other than non-melanoma skin cancer, or cancer that is currently being treated or will be treated during the study. Subjects with cancers that are being treated with hormonal therapy only may be permitted with approval of the Medical Monitor. 8.Inability to consume the study drug, known allergy to the study drug or otherwise comply with the protocol. 9.Have, in the opinion of the Investigator, any medical condition, uncontrolled systemic disease or serious concurrent illness that would significantly decrease study compliance or jeopardize the safety of the subject or affect the validity of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and durability of effect of TRC101 in CKD patients with metabolic acidosis;Secondary Objective: Not applicable; Primary end point(s): Primary Endpoint: Incidence of AEs, SAEs, and AEs leading to withdrawal. ; Timepoint(s) of evaluation of this end point: Primary Endpoint: Until 2 weeks after the end of treatment (Week 52 Visit). | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Secondary endpoint: At the end of treatment (Week 52 Visit). ; Secondary end point(s): Secondary endpoint: 1.Having a change from baseline (CFB) in blood bicarbonate = 4 mEq/L or having blood bicarbonate in the normal range (22 to 29 mEq/L) 2.CFB in blood bicarbonate 3.CFB in the total score of the Kidney Disease and Quality of Life (KDQOL) Question 3 items (daily activities) 4.CFB in repeated chair stand test duration | — |
Countries
Bulgaria, Croatia, Georgia, Hungary, Serbia, Slovenia, Ukraine, United States
Contacts
Public ContactClinical Operations
Tricida, Inc.
Outcome results
None listed