Metabolic AcidosisPhase 3NCT03390842
Long-term Safety Extension to Study TRCA-301
A Phase 3 study testing TRC101 in people with Metabolic Acidosis, run by Tricida, Inc. at 29 sites in 7 countries.
Trial summary
This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with… 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
- 196 participants
- Where
- 29 sitesin 7 countries
- Study dates
- 20 Dec 2017to 22 Feb 2019
- 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
- Completed the 12-week treatment period and attended the Week 12 Visit in the parent study TRCA-301.
- Blood bicarbonate level of >= 12 mEq/L at the Week 12 Visit in the parent study TRCA-301.
Who cannot join
- Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
- Required dialysis for acute kidney injury or worsening CKD during the parent study TRCA-301.
- Planned initiation of renal replacement therapy within 6 months following study entry.
- History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, severe gastrointestinal disorders, inflammatory bowel disease, major gastrointestinal surgery, or active gastric/duodenal ulcers.
- Serum calcium <= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.
Trial locations and contacts
29 sites in 7 countries.
29 sites in 7 countries
United States7 sites
Investigative Site 95
Atlanta, Georgia, 30342
Investigative Site 59
Hialeah, Florida, 33015
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
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
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
Hungary4 sites
Investigative Site 41
Budapest
Investigative Site 46
Budapest
Investigative Site 49
Hódmezővásárhely
Investigative Site 44
Kistarcsa
About this study
Official title: A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.
- 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 group | Role | What they receive |
|---|---|---|
| TRC101 | Experimental | Administered once daily (QD) for 40 weeks Receives: Drug: TRC101 |
| Placebo | Placebo comparator | Administered once daily (QD) for 40 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal.
The incidence of adverse events (AEs), serious adverse events (SAEs) and AEs leading to withdrawal. For incidence of AEs and SAEs, see Adverse Events Section. For incidence of AEs leading to withdrawal, see endpoint values below.
Measured: Week 12 Visit in the parent study, TRCA-301, to the Week 54 Visit in the extension study, TRCA-301E.
Secondary outcomes (4)
Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
Percent of subjects having a change from baseline in serum bicarbonate of at least 4 mEq/L or bicarbonate in the normal range (22 - 29 mEq/L) at the end of treatment (Week 52).
Measured: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
Change From Baseline in Serum Bicarbonate at the End of Treatment
Change from baseline in serum bicarbonate at the end of treatment (Week 52).
Measured: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
Change From Baseline in the Total Score of the KDQOL-PFD at the End of Treatment
Change from baseline in the total score of the Kidney Disease Quality of Life Physical Function Domain (KDQOL-PFD) at the end of treatment. The KDQOL is a validated, kidney disease-specific measure of health-related quality of life. For study TRCA-301E, and the parent study TRCA-301, the 10-question Item 3 of the KDQOL, also known as the SF-36 Physical Function subscale, was selected to measure physical functioning and is referenced herein as the KDQOL-PFD. The KDQOL-PFD was chosen as a patient-reported outcome measurement to evaluate the effects of TRC101 on daily activities that may be adversely affected by loss of muscle caused by metabolic acidosis. The minimum score for each of the 10 questions is 0 (physical activity highly limited) and the maximum is 100 (physical activity not limited). The total KDQOL-PFD score is calculated by adding the scores for all 10 questions, for a minimum and maximum possible total KDQOL-PFD score of 0 or 100, respectively.
Measured: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
Change From Baseline in the Duration of Repeated Chair Stand Test at the End of Treatment
Change from baseline in the duration of repeated chair stand test at the end of treatment (Week 52). The five-times repeated chair stand test was used as a measure of lower extremity muscle strength. In this test, the time it took for a subject to repeatedly stand from a chair five times was recorded. This test is among the group of measures (gait speed, chair stand, and balance tests) comprising the Short Physical Performance Battery (SPPB), which has been used as a predictive tool for possible disability and for monitoring physical functioning in older people.
Measured: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start20 Dec 2017
- Primary completion22 Feb 2019
- Study completion22 Feb 2019
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 (2)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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tricida, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Operations, Study director, Tricida, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390842
- Sponsor's protocol ID
- TRCA-301E
- Status last verified
- Sep 2021
- First submitted
- 28 Dec 2017
- Last updated
- 22 Oct 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. Long-term safety and efficacy of veverimer in patients with metabolic acidosis in chronic kidney disease: a multicentre, randomised, blinded, placebo-controlled, 40-week extension. Lancet. 2019 Aug 3;394(10196):396-406. doi: 10.1016/S0140-6736(19)31388-1. Epub 2019 Jun 24.
PubMed 31248662Mathur VS, Wesson DE, Tangri N, Li E, Bushinsky DA. Effects of veverimer on serum bicarbonate and physical function in women with chronic kidney disease and metabolic acidosis: a subgroup analysis from a randomised, controlled trial. BMC Nephrol. 2022 Feb 25;23(1):82. doi: 10.1186/s12882-022-02690-1.
PubMed 35216581
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects With Chronic Kidney Disease and Metabolic Acidosis
- ClinicalTrials.gov ID
- NCT03390842
- Acronym / sponsor ID
- TRCA-301E
- Conditions
- Metabolic Acidosis
- Keywords
- blood bicarbonate, kidney disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Tricida, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Posted 22 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 40-week, blinded, placebo-controlled extension of Study TRCA-301 (NCT03317444). Eligible subjects who complete the 12-week treatment period in Study TRCA-301 have the option to participate in this extension study evaluating the long-term safety and durability of effect of TRC101 in subjects with non-dialysis dependent chronic kidney disease and metabolic acidosis. Eligible subjects will be treated with TRC101 or placebo once daily (QD) on an out-patient basis for the subsequent 40 weeks. Subjects will continue to receive the same blinded treatment (TRC101 or placebo) that they received in Study TRCA-301.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRC101 | Experimental | Drug: TRC101Administered once daily (QD) for 40 weeks |
| Placebo | Placebo comparator | Drug: PlaceboAdministered once daily (QD) for 40 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completed the 12-week treatment period and attended the Week 12 Visit in the parent study TRCA-301.
- Blood bicarbonate level of >= 12 mEq/L at the Week 12 Visit in the parent study TRCA-301.
Key exclusion criteria (5 listed)
- Any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
- Required dialysis for acute kidney injury or worsening CKD during the parent study TRCA-301.
- Planned initiation of renal replacement therapy within 6 months following study entry.
- History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing disorders, severe gastrointestinal disorders, inflammatory bowel disease, major gastrointestinal surgery, or active gastric/duodenal ulcers.
- Serum calcium <= 8.0 mg/dL at the Week 10 in the parent study TRCA-301.
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
Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal.
Time frame: Week 12 Visit in the parent study, TRCA-301, to the Week 54 Visit in the extension study, TRCA-301E.
The incidence of adverse events (AEs), serious adverse events (SAEs) and AEs leading to withdrawal. For incidence of AEs and SAEs, see Adverse Events Section. For incidence of AEs leading to withdrawal, see endpoint values below.
4 secondary outcomes
Subjects With Change From Baseline in Serum Bicarbonate of ≥ 4 mEq/L or Serum Bicarbonate Within the Normal Range
Time frame: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
Change From Baseline in Serum Bicarbonate at the End of Treatment
Time frame: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
Change From Baseline in the Total Score of the KDQOL-PFD at the End of Treatment
Time frame: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
Change From Baseline in the Duration of Repeated Chair Stand Test at the End of Treatment
Time frame: Baseline in the parent study, TRCA-301, to the Week 52 Visit in the extension study, TRCA-301E.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31248662Wesson DE, Mathur V, Tangri N, Stasiv Y, Parsell D, Li E, Klaerner G, Bushinsky DA. Long-term safety and efficacy of veverimer in patients with metabolic acidosis in chronic kidney disease: a multicentre, randomised, blinded, placebo-controlled, 40-week extension. Lancet. 2019 Aug 3;394(10196):396-406. doi: 10.1016/S0140-6736(19)31388-1. Epub 2019 Jun 24.
- Derived from this study: PubMed 35216581Mathur VS, Wesson DE, Tangri N, Li E, Bushinsky DA. Effects of veverimer on serum bicarbonate and physical function in women with chronic kidney disease and metabolic acidosis: a subgroup analysis from a randomised, controlled trial. BMC Nephrol. 2022 Feb 25;23(1):82. doi: 10.1186/s12882-022-02690-1.
- Individual participant dataSharing planned: No
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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.
29 sites in 7 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 29 sites in 7 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 2 inclusion and 5 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 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Georgia, Ukraine, Hungary, Slovenia and 2 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 22 Oct 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?
Incidence of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Withdrawal. (time frame: Week 12 Visit in the parent study, TRCA-301, to the Week 54 Visit in the extension study, TRCA-301E.). 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 NCT03390842, which also lists 2 linked publications.
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 22 Oct 2021.