A Phase 3 interventional study of TRC101 and Placebo in Metabolic Acidosis, sponsored by Tricida, Inc.. Completed at 44 sites in 8 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-04-26.
Sponsored by Tricida, Inc. · Phase 3, Interventional, and Treatment
This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12 weeks once daily.
The maximum study duration is anticipated to be up to 16 weeks.
111 studies on the registry are indexed under Acidosis; 19 are open to participants now.
This study's enrollment of 217 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.
Key Inclusion Criteria:
Key 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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administered once daily (QD) for 12 weeks
Drug: TRC101
Administered once daily (QD) for 12 weeks
Drug: Placebo
Oral suspension
Also known as: Veverimer
Oral suspension
Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
Composite endpoint of the percentage of subjects having a change from baseline in serum bicarbonate ≥ 4 mEq/L or having serum bicarbonate in the normal range (22 - 29 mEq/L) at the end of treatment (Week 12 Visit).
Time frame: Baseline to Week 12
Change From Baseline to End of Treatment in Serum Bicarbonate
Mean change from baseline to end of treatment (Week 12 Visit) in serum bicarbonate
Time frame: Baseline to Week 12
| Milestone | TRC101 Treatment Arm | Placebo Treatment Arm |
|---|---|---|
| Started | 124 | 93 |
| Completed | 119 | 89 |
| Not completed | 5 | 4 |
Composite endpoint of the percentage of subjects having a change from baseline in serum bicarbonate ≥ 4 mEq/L or having serum bicarbonate in the normal range (22 - 29 mEq/L) at the end of treatment (Week 12 Visit).
| percentage of participants | TRC101 Treatment Arm | Placebo Treatment Arm |
|---|---|---|
| Subjects with change from baseline serum bicarbonate ≥ 4 mEq/L or serum bicarbonate in normal range | 59.2 (49.8 to 68.0) | 22.5 (14.3 to 32.6) |
| Subjects with change from baseline serum bicarbonate ≥ 4 mEq/L | 55.8 (46.5 to 64.9) | 21.3 (13.4 to 31.3) |
| Subjects with serum bicarbonate in normal range | 50.0 (40.7 to 59.3) | 16.9 (9.8 to 26.3) |
Mean change from baseline to end of treatment (Week 12 Visit) in serum bicarbonate
| mEq/L | TRC101 Treatment Arm | Placebo Treatment Arm |
|---|---|---|
| Change From Baseline to End of Treatment in Serum Bicarbonate | 4.42 (3.85 to 4.98) | 1.78 (1.13 to 2.44) |
Collected over Data are the number of patients with adverse events occurring on or after the date of the first dose of TRC101 or placebo up to 14 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TRC101 Treatment Arm | 0/124 (0%) | 3/124 (2.4%) | 31/124 (25%) |
| Placebo Treatment Arm | 2/93 (2.2%) | 2/93 (2.2%) | 13/93 (14%) |
| Event | TRC101 Treatment Arm | Placebo Treatment Arm |
|---|---|---|
| Angina unstableCardiac disorders | 0/124 | 1/93 |
| Diabetic hyperglycaemic comaNervous system disorders | 0/124 | 1/93 |
| PneumoniaInfections and infestations | 0/124 | 1/93 |
| FallInjury, poisoning and procedural complications | 1/124 | 0/93 |
| Acute left ventricular failureCardiac disorders | 1/124 | 0/93 |
| Cardiac failure congestiveCardiac disorders | 1/124 | 0/93 |
| AstheniaGeneral disorders | 1/124 | 0/93 |
| Acute kidney injuryRenal and urinary disorders | 1/124 | 0/93 |
| Event | TRC101 Treatment Arm | Placebo Treatment Arm |
|---|---|---|
| HyperkalaemiaMetabolism and nutrition disorders | 13/124 | 6/93 |
| DiarrhoeaGastrointestinal disorders | 11/124 | 3/93 |
| HeadacheNervous system disorders | 7/124 | 4/93 |
| Age, Categorical(Participants) | TRC101 Treatment Arm | Placebo Treatment Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 59 | 44 | 103 |
| >=65 years | 65 | 49 | 114 |
| Age, Continuous(years) | TRC101 Treatment Arm | Placebo Treatment Arm | Total |
|---|---|---|---|
| Mean | 62.9 ± 12.64 | 63.3 ± 12.08 | 63.1 ± 12.38 |
| Sex: Female, Male(Participants) | TRC101 Treatment Arm | Placebo Treatment Arm | Total |
|---|---|---|---|
| Female | 50 | 33 | 83 |
| Male | 74 | 60 | 134 |
| Race (NIH/OMB)(Participants) | TRC101 Treatment Arm | Placebo Treatment Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 121 | 89 | 210 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| History of Hypertension(Participants) | TRC101 Treatment Arm | Placebo Treatment Arm | Total |
|---|---|---|---|
| Count of participants | 120 | 90 | 210 |
| History of Diabetes Mellitus(Participants) | TRC101 Treatment Arm | Placebo Treatment Arm | Total |
|---|---|---|---|
| Count of participants | 76 | 65 | 141 |
| History of Congestive Heart Failure(Participants) | TRC101 Treatment Arm | Placebo Treatment Arm | Total |
|---|---|---|---|
| Count of participants | 36 | 31 | 67 |
| Baseline Estimated Glomerular Filtration Rate (eGFR)(mL/min/1.73m^2) | TRC101 Treatment Arm | Placebo Treatment Arm | Total |
|---|---|---|---|
| Mean | 29.2 ± 6.29 | 27.8 ± 5.45 | 28.6 ± 5.97 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in May 2018, 7 months.
Results were first posted in Apr 2021, 2 years 11 months after primary completion. A results delay was requested in Mar 2019.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. 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.