Metabolic AcidosisPhase 3NCT03317444

Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease

A Phase 3 study testing TRC101 in people with Metabolic Acidosis, run by Tricida, Inc. at 44 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Metabolic Acidosis
What is being tested?: TRC101
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 217 participants
Where: 44 sitesin 8 countries
Study dates: 26 Sep 2017to 15 May 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Blood bicarbonate level of 12 to 20 mEq/L.
Estimated glomerular filtration rate (eGFR) of 20 to 40 mL/min/1.73m2.
Stable kidney function defined as <=20% variability in eGFR during screening period.

Who cannot join

Any level of low blood bicarbonate during the screening period that in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
Anuria, dialysis, acute kidney injury, or history of acute kidney insufficiency within 3 months prior to screening.
Heart failure with maximum New York Heart Association (NYHA) Class IV symptoms or that required hospitalization during the preceding 6 months.
Heart or kidney transplant.
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.
Change in doses to alkali therapy in the 4 weeks prior to screening.

Show all 10Show fewer

History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, inflammatory bowel disease, major gastrointestinal surgery, frequent diarrhea or active gastric/duodenal ulcers.
Serum calcium <= 8.0 mg/dL at screening.
Planned initiation of renal replacement therapy within 12 weeks following randomization.
Use of polymeric binder drugs within 14 days prior to screening.

Trial locations and contacts

44 sites in 8 countries.

Country

City, postcode or hospital

44 sites in 8 countries

United States13 sites

Investigative Site 95
Atlanta, Georgia, 30342
Investigative Site 56
Chula Vista, California, 91910
Investigative Site 58
Flushing, New York, 11355
Investigative Site 59
Hialeah, Florida, 33015
Investigative Site 54
Hollywood, Florida, 33021
Investigative Site 93
Hollywood, Florida, 33024
Investigative Site 92
Lauderdale Lakes, Florida, 33313
Investigative Site 91
Los Angeles, California, 90022
Investigative Site 55
Phoenix, Arizona, 85032
Investigative Site 52
San Antonio, Texas, 78215
Investigative Site 53
Shreveport, Louisiana, 71101
Investigative Site 51
Tampa, Florida, 33614
Investigative Site 57
Winter Park, Florida, 32789

Other trials in United States

Hungary9 sites

Investigative Site 43
Baja
Investigative Site 48
Balatonfüred
Investigative Site 41
Budapest
Investigative Site 46
Budapest
Investigative Site 45
Hatvan
Investigative Site 49
Hódmezővásárhely
Investigative Site 44
Kistarcsa
Investigative Site 42
Miskolc
Investigative Site 47
Mosonmagyaróvár

Other trials in Hungary

Georgia7 sites

Investigative Site 31
Tbilisi
Investigative Site 32
Tbilisi
Investigative Site 33
Tbilisi
Investigative Site 34
Tbilisi
Investigative Site 35
Tbilisi
Investigative Site 36
Tbilisi
Investigative Site 37
Tbilisi

Other trials in Georgia

Ukraine7 sites

Investigative Site 81
Kharkiv
Investigative Site 83
Kharkiv
Investigative Site 87
Kharkiv
Investigative Site 88
Kharkiv
Investigative Site 84
Kyiv
Investigative Site 85
Kyiv
Investigative Site 86
Kyiv

Other trials in Ukraine

Serbia4 sites

Investigative Site 64
Belgrade
Investigative Site 65
Belgrade
Investigative Site 61
Vršac
Investigative Site 62
Zrenjanin

Other trials in Serbia

Slovenia2 sites

Investigative Site 72
Jesenice
Investigative Site 71
Maribor

Other trials in Slovenia

Bulgaria1 site

Investigative Site 11
Sofia

Other trials in Bulgaria

Croatia1 site

Investigative Site 21
Zagreb

Other trials in Croatia

About this study

Official title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis

The maximum study duration is anticipated to be up to 16 weeks.

Conditions: Metabolic Acidosis
Being tested: TRC101, Placebo
Keywords: blood bicarbonate, kidney disease
Medical subject headings: Acidosis, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TRC101Drug
Also called Veverimer
Oral suspension
PlaceboDrug
Oral suspension

Study groups in NCT03317444
Study group	Role	What they receive
TRC101	Experimental	Administered once daily (QD) for 12 weeks Receives: Drug: TRC101
Placebo	Placebo comparator	Administered once daily (QD) for 12 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline to Week 12

Secondary outcomes (1)

Change From Baseline to End of Treatment in Serum Bicarbonate
Mean change from baseline to end of treatment (Week 12 Visit) in serum bicarbonate
Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 201715 May 2018

First posted23 Oct 2017
Study start26 Sep 2017
Primary completion4 May 2018
Study completion15 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metabolic AcidosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 217 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03317444
Sponsor's protocol ID: TRCA-301
Other IDs: 2016-003825-41, 2016
Status last verified: Mar 2021
First submitted: 11 Oct 2017
Last updated: 26 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Wesson DE, Mathur V, Tangri N, Stasiv Y, Parsell D, Li E, Klaerner G, Bushinsky DA. Veverimer versus placebo in patients with metabolic acidosis associated with chronic kidney disease: a multicentre, randomised, double-blind, controlled, phase 3 trial. Lancet. 2019 Apr 6;393(10179):1417-1427. doi: 10.1016/S0140-6736(18)32562-5. Epub 2019 Mar 8.
PubMed 30857647

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metabolic Acidosis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
ClinicalTrials.gov ID: NCT03317444
Acronym / sponsor ID: TRCA-301
Conditions: Metabolic Acidosis
Keywords: blood bicarbonate, kidney disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 217 participants (actual)
Lead sponsor: Tricida, Inc.Industry (pharma, biotech, devices)
Study start: 26 Sep 2017 (actual)
Primary completion: 4 May 2018 (actual)
Study completion: 15 May 2018 (actual)
First posted: 23 Oct 2017 (actual)
Results: Posted 26 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The maximum study duration is anticipated to be up to 16 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TRC101	Experimental	Drug: TRC101Administered once daily (QD) for 12 weeks
Placebo	Placebo comparator	Drug: PlaceboAdministered once daily (QD) for 12 weeks

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Blood bicarbonate level of 12 to 20 mEq/L.
Estimated glomerular filtration rate (eGFR) of 20 to 40 mL/min/1.73m2.
Stable kidney function defined as <=20% variability in eGFR during screening period.

Key exclusion criteria (10 listed)

Any level of low blood bicarbonate during the screening period that in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
Anuria, dialysis, acute kidney injury, or history of acute kidney insufficiency within 3 months prior to screening.
Heart failure with maximum New York Heart Association (NYHA) Class IV symptoms or that required hospitalization during the preceding 6 months.
Heart or kidney transplant.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TRC101Also: VeverimerOral suspension	Drug	TRC101
PlaceboOral suspension	Drug	Placebo

Primary outcome

Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
Time frame: Baseline to Week 12
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).

1 secondary outcome

Change From Baseline to End of Treatment in Serum Bicarbonate
Time frame: Baseline to Week 12

Results and safety

Results posted to the registry on 26 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TRC101 Treatment Arm	124	119
Placebo Treatment Arm	93	89

Primary outcome: Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range

Time frame: Baseline to Week 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	TRC101 Treatment Arm n = 120	Placebo Treatment Arm n = 89
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)

TRC101 Treatment Arm vs Placebo Treatment Arm: Treatment difference in % of subjects: 36.7 (95% CI 23.5 to 48.9), p < 0.0001, Fisher Exact
TRC101 Treatment Arm vs Placebo Treatment Arm: Treatment difference in % of subjects: 34.5 (95% CI 21.2 to 46.8), p < 0.0001, Fisher Exact
TRC101 Treatment Arm vs Placebo Treatment Arm: Treatment difference in % of subjects: 33.1 (95% CI 19.7 to 45.6), p < 0.0001, Fisher Exact

Population analysed: The Modified Intent-to-Treat (MITT) Analysis Set was defined as all randomized subjects who had both baseline and at least one postbaseline serum bicarbonate value measured using an i-STAT device. The MITT Analysis Set was used for evaluation of efficacy, based on planned treatment assignment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TRC101 Treatment Arm	3 of 124 (2.4%)	31 of 124 (25%)	0 of 124
Placebo Treatment Arm	2 of 93 (2.2%)	13 of 93 (14%)	2 of 93

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30857647Wesson DE, Mathur V, Tangri N, Stasiv Y, Parsell D, Li E, Klaerner G, Bushinsky DA. Veverimer versus placebo in patients with metabolic acidosis associated with chronic kidney disease: a multicentre, randomised, double-blind, controlled, phase 3 trial. Lancet. 2019 Apr 6;393(10179):1417-1427. doi: 10.1016/S0140-6736(18)32562-5. Epub 2019 Mar 8.
Individual participant dataSharing planned: No

Related trials for Metabolic Acidosis

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Potential Impact of the Use of the Application VentilO
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Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Operations study director

Tricida, Inc.

44 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TRC101 in people with Metabolic Acidosis, run by Tricida, Inc. at 44 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Hungary, Georgia, Ukraine, Serbia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03317444, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.