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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,480
Progression of chronic kidney disease
Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death.
Time frame: Through study completion, up to approximately 6 years.
Death (all-cause), ESRD or a confirmed ≥50% reduction in eGFR
Time to first occurrence of: death (all-cause); ESRD; a confirmed ≥50% reduction in eGFR.
Time frame: Through study completion, up to approximately 6 years.
Physical functioning (subjective)
Kidney Disease Quality of Life Physical Functioning Survey.
Time frame: 18 months after randomization.
Physical functioning (objective)
Repeated chair stand test.
Time frame: 18 months after randomization.
ESRD or renal death
Time to ESRD or renal death.
Time frame: Through study completion, up to approximately 6 years.
Primary outcome measure OR cardiovascular death
Time to first occurrence of: a confirmed ≥40% reduction in eGFR; ESRD; renal death; cardiovascular death.
Time frame: Through study completion, up to approximately 6 years.
Serum creatinine
Time to first occurrence of a confirmed doubling of serum creatinine.
Time frame: Through study completion, up to approximately 6 years.
≥50% reduction in eGFR
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Investigative Site 4136
Azusa, California, United States
Investigative Site 4148
Denver, Colorado, United States
Investigative Site 4157
Boca Raton, Florida, United States
Investigative Site 4146
Bradenton, Florida, United States
Investigative Site 4102
Coral Springs, Florida, United States
Investigative Site 4153
Fort Lauderdale, Florida, United States
Investigative Site 4122
Hollywood, Florida, United States
Investigative Site 4123
Hollywood, Florida, United States
Investigative Site 4104
Miami, Florida, United States
Investigative Site 4130
Miami Lakes, Florida, United States
...and 193 more locations
Time to first occurrence of a confirmed ≥50% reduction in eGFR.
Time frame: Through study completion, up to approximately 6 years.
≥40% reduction in eGFR
Time to first occurrence of a confirmed ≥40% reduction in eGFR.
Time frame: Through study completion, up to approximately 6 years.
All-cause hospitalization
Frequency of all-cause hospitalization.
Time frame: Through study completion, up to approximately 6 years.
Cardiovascular death
Time to cardiovascular death.
Time frame: Through study completion, up to approximately 6 years.
All-cause mortality
Time to all-cause mortality.
Time frame: Through study completion, up to approximately 6 years.