A Phase 3 interventional study of TRC101 and Placebo in Metabolic Acidosis and Chronic Kidney Disease, sponsored by Tricida, Inc.. Terminated at 203 sites in 34 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-10-14.
Sponsored by Tricida, Inc. · Phase 3, Interventional, and Treatment
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.
111 studies on the registry are indexed under Acidosis; 19 are open to participants now.
This study's enrollment of 1,480 is above the median of 52 across 79 interventional studies indexed under Acidosis.
Browse Acidosis studies →Tricida, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: TRC101
Drug: Placebo
Oral, non-absorbed, polymeric hydrochloric acid binder
Also known as: Veverimer
Placebo comparator
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
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.
Safety of TRC101
Frequency, intensity, and relationship to study drug of adverse events and serious adverse events.
Time frame: Through study completion, up to approximately 6 years.
Showing the first 100 of 203 sites across 34 countries. Choose a country and city above to see the rest.
Plan to share: No
This study is terminated, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Veverimer
Tricida, Inc.