Chronic Kidney Disease, Metabolic Acidosis
Conditions
Keywords
serum bicarbonate, renal outcomes, TRC101, eGFR, veverimer
Brief summary
The purpose of this study is to evaluate the effect of TRC101 on the progression of chronic kidney disease (CKD) and to evaluate the safety profile of TRC101 in CKD patients with metabolic acidosis.
Detailed description
This is a randomized, double-blind, placebo-controlled trial. Eligible subjects will be randomized in a 1:1 ratio to TRC101 or placebo. The primary endpoint of the study will be progression of renal 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), and renal death. The study will terminate when the independent blinded Clinical Endpoint Adjudication Committee has positively adjudicated the targeted number of primary efficacy endpoint events. The maximum duration of follow-up for a randomized subject is anticipated to be approximately 6 years.
Interventions
DRUGTRC101
Oral, non-absorbed, polymeric hydrochloric acid binder
DRUGPlacebo
Placebo comparator
Sponsors
Tricida, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Estimated glomerular filtration rate (eGFR) 20 - 40 mL/min/1.73m\^2. * Serum bicarbonate 12 - 20 mEq/L. * On maximum tolerated dose of ACE inhibitor and/or ARB.
Exclusion criteria
* Acute metabolic acidosis. * Anticipated dialysis or kidney transplant within 6 months. * Recent acute kidney injury.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression of chronic kidney disease | Through study completion, up to approximately 6 years. | Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death (all-cause), ESRD or a confirmed ≥50% reduction in eGFR | Through study completion, up to approximately 6 years. | Time to first occurrence of: death (all-cause); ESRD; a confirmed ≥50% reduction in eGFR. |
| Physical functioning (subjective) | 18 months after randomization. | Kidney Disease Quality of Life Physical Functioning Survey. |
| Physical functioning (objective) | 18 months after randomization. | Repeated chair stand test. |
| ESRD or renal death | Through study completion, up to approximately 6 years. | Time to ESRD or renal death. |
| Primary outcome measure OR cardiovascular death | Through study completion, up to approximately 6 years. | Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death; cardiovascular death. |
| ≥50% reduction in eGFR | Through study completion, up to approximately 6 years. | Time to first occurrence of a confirmed ≥50% reduction in eGFR. |
| ≥40% reduction in eGFR | Through study completion, up to approximately 6 years. | Time to first occurrence of a confirmed ≥40% reduction in eGFR. |
| All-cause hospitalization | Through study completion, up to approximately 6 years. | Frequency of all-cause hospitalization. |
| Cardiovascular death | Through study completion, up to approximately 6 years. | Time to cardiovascular death. |
| All-cause mortality | Through study completion, up to approximately 6 years. | Time to all-cause mortality. |
| Serum creatinine | Through study completion, up to approximately 6 years. | Time to first occurrence of a confirmed doubling of serum creatinine. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety of TRC101 | Through study completion, up to approximately 6 years. | Frequency, intensity, and relationship to study drug of adverse events and serious adverse events. |
Countries
Albania, Argentina, Armenia, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, France, Georgia, Hong Kong, Hungary, Israel, Italy, Malaysia, Mexico, Netherlands, North Macedonia, Poland, Portugal, Romania, Serbia, Singapore, Slovakia, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Outcome results
None listed