Clinical Trials List
2020-11-19 - 2024-12-31
Phase III
Recruiting11
Terminated1
ICD-10N18.9
Chronic kidney disease, unspecified
ICD-10E87.2
Acidosis
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
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Trial Applicant
GEORGE CLINICAL ASIA PACIFIC LIMITED
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Sponsor
Tricida, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
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The Actual Total Number of Participants Enrolled
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The Actual Total Number of Participants Enrolled
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The Actual Total Number of Participants Enrolled
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Co-Principal Investigator
- Ming-Ju Wu Division of Nephrology
- 蔡尚峰 Division of Nephrology
- 徐佳鈿 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
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The Actual Total Number of Participants Enrolled
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The Actual Total Number of Participants Enrolled
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The Actual Total Number of Participants Enrolled
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The Actual Total Number of Participants Enrolled
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Co-Principal Investigator
- 黃道民 Division of Nephrology
- 楊紹佑 Division of Nephrology
- - - Division of Nephrology
- CHUN-FU LAI Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yen-Chung Lin Division of Nephrology
- Yueh-Lin Wu Division of Nephrology
- Te-Chao Fang Division of Nephrology
- Chih-Chin Kao Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The primary efficacy endpoint of the study is progression of chronic kidney disease, defined
by time to first occurrence of any event in the composite endpoint consisting of:
• A confirmed ≥ 40% reduction in eGFR
• End-stage renal disease (ESRD)
• Renal death
The primary efficacy assessment will be a comparison between the active and placebo groups
in the time to first occurrence of any component of the composite endpoint as adjudicated by
an independent blinded CEAC.
Inclution Criteria
Each subject must meet all of the following criteria to be enrolled in this study.
1. Have provided written informed consent prior to participation in the study.
2. Male or female subjects 18 to 85 years of age, inclusive, at Screening 1 Visit.
3. The mean of two Screening eGFR measurements, drawn at least 2 weeks apart and
both within 6 weeks of the first day of Part A, is 20 to 40 mL/min/1.73m2
, inclusive,
calculated using the CKD-EPI equation as reported by the central laboratory.
• Note: If more than two eGFR values were measured at the central laboratory
during the Screening Period, the Screening eGFR will be based on the most
recent two values that are at least 2 weeks apart and within 6 weeks of the
first day of Part A.
Enrollment of patients with Screening eGFR in the range 15 to
20 mL/min/1.73m2 may be allowed in the future with notification to the sites by
Tricida and will not require a protocol amendment. Subjects with a Screening eGFR
value in the range of 15 to <20 mL/min/1.73m2 may not be enrolled until Tricida has
authorized this change in writing.
4. Have stable renal function as defined by eGFR Screening values that are not different
by > 20% (the higher of the two Screening eGFR values will be used as the
denominator to calculate the 20% allowable difference).
• Note: If more than two eGFR values were measured at the central laboratory
during the Screening Period, the first and last values must be used for
calculation of the allowable eGFR difference.
5. Based on onsite measurement using an i-STAT point of care device, have three serum
bicarbonate values, each ≥ 2 weeks apart from each other and all within 6 weeks of
the A1 Visit, in the range from 12 to 20 mEq/L, inclusive. One of these three values
must be from the A1 Visit, pre-dose.
One same-day retest using the i-STAT point of care device is allowed from Screening
1 Visit through the A1 Visit.
Subjects with Baseline Bicarbonate (defined as the average of the serum bicarbonate
values at Screening 1, Screening 2 and the A1 Visit [predose]) values of 12 to
18 mEq/L are eligible without restriction. Once approximately half of study subjects
have been randomized with Baseline Bicarbonate > 18 to 20 mEq/L, randomization
may be closed to additional subjects with Baseline Bicarbonate in this range.
6. Mean systolic and diastolic blood pressure (determined as the average of three
replicates) must be < 160/92 mmHg at the Screening 2 Visit.
7. Receiving treatment with an ACE inhibitor and/or ARB at the maximum tolerated
(for the individual subject) dose within the country-specific labeled dose range,
without adjustments, for ≥ 4 weeks prior to the Screening 1 Visit and during the
Screening Period. The maximum tolerated dose for an individual subject may be less
than the maximum labeled dose or may be zero if the medical reason is documented.
Subjects not treated with an ACE inhibitor or ARB must be approved by the Medical
Monitor following a review of the medical justification.
Non-diabetic subjects with urine ACR < 30 mg/g (3.39 mg/mmol) are not required to
be receiving treatment with an ACE inhibitor and/or ARB.
8. If receiving an oral alkali supplement, the dose must be stable for ≥ 2 weeks prior to
Screening 1 Visit and during the Screening Period.
If not receiving alkali treatment, there must be no such treatment within the 2 weeks
prior to Screening 1 Visit or during the Screening Period.
9. Have a hemoglobin A1c (HbA1c) value of ≤ 11.0% (0.11 fraction; 97 mmol/mol) at
the Screening 1 Visit (based on central laboratory measurement).
10. Have adequate peripheral venous access for blood draws.
11. Women who are of childbearing potential must have negative pregnancy tests at the
Screening 1 and Part B Day 1 Visits and be willing to use an acceptable method of
birth control from the Screening 1 Visit until 1 week after study drug 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.
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from participation in the
study.
1. Have any level of low serum bicarbonate at either Screening Visit that, in the
opinion of the Investigator, requires emergency intervention or evaluation for
an acute acidotic process.
2. Have had anuria, dialysis, or acute kidney injury/acute renal failure in the 3
months prior to the Screening 1 Visit.
3. Have chronic obstructive pulmonary disease (COPD) that is treated with
chronic oral steroids, that requires the subject to be on oxygen, or that required
hospitalization within the previous 6 months.
4. Had heart failure with maximum New York Heart Association (NYHA) Class
IV symptoms (see Appendix 5) during the 3 months prior to the Screening 1
Visit.
5. Had a heart, liver or kidney transplant.
Note: Subjects on the cadaveric transplant list or being evaluated for a future
living donor transplant may be enrolled.
6. Have planned initiation of renal replacement therapy (dialysis or
transplantation) within 6 months following randomization
7. Have had a stroke or transient ischemic attack within the 6 months prior to
Screening 1 Visit.
8. Have had a cardiac event within 3 months prior to Screening 1 Visit, including:
myocardial infarction, acute coronary syndrome, coronary bypass grafting,
percutaneous coronary intervention, valve procedure, inpatient or outpatient
treatment for acute decompensated heart failure.
9. Have been hospitalized for any reason during the 2 months prior to the
Screening 1 Visit, other than for pre-planned diagnostic or minor invasive
procedures (e.g., placement of dialysis access).
10. Have an ileostomy or colostomy or have had a bowel resection or bariatric
surgery. Subjects who have had gastric lap band procedures (no gastric
resection) are allowed.
11. Have liver enzyme (alanine aminotransferase [ALT], aspartate
aminotransferase [AST]) or total bilirubin values > 3× the upper limit of
normal (ULN) at the Screening 2 Visit based on central laboratory
measurements.
12. Have a corrected serum calcium < 8.0 mg/dL (2 mmol/L; 80 mg/L) at the
Screening 1 Visit, based on central laboratory measurement.
13. Have active cancer during the 1 year prior to the Screening 1 Visit or cancer
that is currently being treated or will be treated during the study, other than
non-melanoma skin cancer or low-grade cervical carcinoma. Subjects with
cancers that are being treated with hormonal therapy only may be permitted
with approval of the Medical Monitor.
14. Have received any investigational drug during the last month (28 days or ≥ 5
half-lives [if known], whichever is longer) preceding the Screening 1 Visit or
during Screening.
15. Have a known allergy to placebo (microcrystalline cellulose).
16. Have an inability to consume the study drug or otherwise comply with the
protocol.
17. Has received cytotoxic therapy, immunosuppressive therapy, or other
immunotherapy for renal disease within 6 months prior to the Screening 1 Visit
or during the Screening Period.
Note: Glucocorticoid use is allowed.
18. Have a history of alcoholism or drug/chemical abuse, as defined by The
Diagnostic and Statistical Manual of Mental Disorders (DSM-5), within
6 months prior to the Screening 1 Visit.
19. 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
interpretability of the subject’s data.
20. Participated (i.e., was randomized) in Study TRCA-301.
21. Are pregnant or currently breastfeeding
The Estimated Number of Participants
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Taiwan
190 participants
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Global
participants
