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RecruitingNCT07355062Updated Oct 23, 2026

A Study to Evaluate the Efficacy and Safety of Veverimer for the Treatment of Metabolic Acidosis

A Phase 3 interventional study of Veverimer and Placebo in CKD and Metabolic Acidosis, sponsored by Renibus Therapeutics, Inc.. Recruiting at 28 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Renibus Therapeutics, Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Updated Oct 23, 2026Site recruiting status changed3 sites addedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is is to evaluate the efficacy and safety of veverimer in treating adults with moderate-to-severe chronic kidney disease (CKD) and metabolic acidosis.

02

Conditions studied

  • CKD
  • Metabolic Acidosis

Browse trials for

Keywords

  • CKD
  • Metabolic Acidosis
  • Veverimer
  • STS5
  • Bicarbonate
03

In context

Acidosis

111 studies on the registry are indexed under Acidosis; 19 are open to participants now.

This study's planned enrollment of 150 is above the median of 52 across 79 interventional studies indexed under Acidosis.

Browse Acidosis studies →

Lead sponsor

Renibus Therapeutics, Inc. is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Have provided written prior to participation in the study.
  • Male or female participants 18 years of age or older.
  • Diagnosed with CKD ( \< 60 mL/min/1.73m2) and not expected to require renal replacement therapy (dialysis or kidney transplant) throughout the duration of the study.
  • Within 6 months prior to screening have at least two SBC between 12 and 20 mmol/L, inclusive. If only one historical SBC is available, a second SBC may be drawn on screening visit S1 and analyzed by the local laboratory.
  • Within screening period have two central laboratory SBC (at least 24 hours apart and more than 4 hours after food) between 12 and 21 mmol/L, inclusive.
  • Willing to keep food consumption similar to baseline throughout the entire study.
  • If taking oral alkali therapy, dose has been stable for at least 28 days prior to the start of screening and is expected to remain stable throughout the study.
  • Women who are of must have a negative pregnancy test and agree to abstinence or to use .

Exclusion criteria

Exclusion Criteria:

  • Any participant deemed by the Investigator to be an inappropriate candidate for PerfO testing (e.g., severe musculoskeletal pain, non-ambulatory status), inability to complete STS5 without support or with a screening STS5 time \< 10 seconds.
  • History or current diagnosis of:

    1. gastroparesis or a history of bariatric surgery.
    2. Bowel obstruction, swallowing disorders, severe gastrointestinal disorders, including inflammatory bowel disease, major gastrointestinal surgery including gastrectomy, or known active gastric/duodenal ulcers.
    3. Severe recurrent diarrhea or constipation, as assessed by the Investigator.
    4. Pernicious anemia, atrophic or gastritis, achlorhydria or hypochlorhydria.
  • Ineligible per REVIVE GastroScreen test.
  • Use of GI polymer binders or sodium zirconium cyclosilicate within 14 days prior to the start of screening or have an expectation to initiate treatment during the study.
  • Use of acid reducing drugs, including PPIs, H2RAs or P-CABs within 14 days prior to the start of screening or have an expectation to initiate treatment during the study. Very sporadic use (one time per week or less) may be acceptable, as assessed by the Investigator.
  • Initiation of GLP-1 receptor agonists within 6 months prior to the start of screening, or expectation to initiate use during the study. Participants that have been on a GLP-1 receptor agonist for more than 6 months and have maintained a stable dose and steady body weight for at least one month prior to the start of screening may be considered for enrollment, upon Medical Monitor review. GLP-1 receptor agonists also should not be started during the study.
  • Participants that are taking any of the following medications and have not been on a stable dose for at least 14 days prior to the start of screening or have an expectation to change dose during the study: diuretics, non-ophthalmic carbonic anhydrase inhibitors, diabetes drugs, RAAS inhibitors, calcium or magnesium supplements, non-polymer phosphate binders, and SGLT-2 inhibitors. These medications also should not be started during the study.
  • Active, recurrent, or at the start of screening.
  • History of malignancy, except under the following conditions:

    1. Carcinoma in situ (e.g., of the cervix, breast, or bladder) that has been completely excised and shows no evidence of residual disease.
    2. Non-melanoma skin cancers (e.g., basal cell carcinoma, squamous cell carcinoma) that have been completely excised and show no evidence of recurrence.
    3. Low grade prostate cancer, in the opinion of the Investigator (i.e., no metastasis, Gleason score \< 6), with no significant worsening for > 6 months prior to the screening visit.
    4. Any other malignancy that was treated with curative intent and has been in complete remission for ≥ 5 years prior to the screening visit.
  • Two or more hospitalizations within 12 months prior to the start of screening or a hospitalization within the last 3 months prior to the start of screening due to fluid overload, heart failure, acute kidney injury (AKI) or electrolyte disorders, including hyperkalemia. Participants that have not been hospitalized within the past 3 months and whose condition is stable may be considered for enrollment.
  • Screening \< 9 g/dL.
  • Low bicarbonate value(s) at time of screening that are due to underlying primary respiratory alkalosis.
  • medication administration within 28 days prior to start of screening.
  • Participants that are taking an average of > 30 units of insulin daily, unless recent (within last 6 months) is \< 6.5%.
  • History of alcoholism or drug/chemical abuse within 1 year prior to the start of screening, in the opinion of the Investigator.
  • Current, regular use of inhaled/ingested cannabis/THC products.
  • Inability to take the IP or otherwise comply with the protocol.
  • Any medical condition, uncontrolled systemic disease or serious concurrent illness that would significantly decrease study compliance or jeopardize the safety of the participant or affect the validity of the trial results, in the opinion of the Investigator.
Terms in these criteria, in plain language(11)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Veverimer

    Drug: Veverimer

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • Group 1: 9 g veverimer BID

  • DrugPlacebo

    Group 2: 9 g PBO BID

06

What researchers measure

Primary outcomes

  1. Efficacy of Veverimer by measuring change in serum bicarbonate concentration (SBC)

    Time frame: Visits: Screening to Day 168

  2. Efficacy of Veverimer in improving physical performance as assessed by the Sit-to-Stand 5 times test (STS5).

    Time frame: Visits: Screening to Day 168

Secondary outcomes

  1. Efficacy of Veverimer in achieving SBC and responder thresholds.

    Change from baseline in SBC. Achievement of SBC thresholds (\> 4 mmol/L increase from baseline and/or \> 23 mmol/L).

    Time frame: Visits: Screening to Day 168

  2. Performance outcomes (PerfO).

    Change in Patient Global Impression of Change of Physical Functioning (PGI-C) Patients answer 1 question: How would you rate your current level of physical functioning (mobility and ability to do everyday physical activities) compared to the beginning of the study? Much better, Moderately better, A little better, No change, A little worse, Moderately worse, Much worse. Lower score is a better outcome. Change in Patient Global Impressions Scale - Severity (PGI-S) Patients answer 1 question: How would you rate your current level of physical functioning (mobility and ability to do everyday physical activities)? Poor, Fair, Good, Very good, Excellent. Higher score is a better outcome.

    Time frame: Visits: Screening to Day 168

  3. Frailty and muscle mass assessment.

    Change in performance on 6-minute walk test 6MWT.

    Time frame: Visits: Screening to Day 168

  4. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].

    Time frame: Visits: Screening to Day 168

07

Study locations

27 of 28 sites recruiting
  • Study Site
    Chula Vista, California 91910, United States
    Recruiting
  • Study Site
    Los Angeles, California 90022, United States
    Recruiting
  • Study Site
    Sacramento, California 95817, United States
    Recruiting
  • Study Site
    San Diego, California 92111, United States
    Recruiting
  • Study Site
    Aurora, Colorado 80045, United States
    Recruiting
  • Study Site
    Newark, Delaware 19713, United States
    Recruiting
  • Study Site
    Edgewater, Florida 32132, United States
    Recruiting
  • Study Site
    Margate, Florida 33063, United States
    Recruiting
  • Study Site
    Miami Springs, Florida 33166, United States
    Recruiting
  • Study Site
    Orlando, Florida 32806, United States
    Recruiting
  • Study Site
    Augusta, Georgia 30904, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Study Site
    Boise, Idaho 83706, United States
    Recruiting
  • Study Site
    Chubbuck, Idaho 83201, United States
    Recruiting
  • Study Site
    Idaho Falls, Idaho 83401, United States
    Recruiting
  • Study Site
    Chicago, Illinois 60643, United States
    Recruiting
  • Study Site
    Indianapolis, Indiana 46202, United States
    Recruiting
  • Study Site
    Louisville, Kentucky 40205, United States
    Recruiting
  • Study Site
    New Orleans, Louisiana 70112, United States
    Recruiting
  • Study Site
    Detroit, Michigan 48202, United States
    Recruiting
  • Study Site
    Pontiac, Michigan 48341, United States
    Recruiting
  • Study Site
    Kansas City, Missouri 64111, United States
    Recruiting
  • Study Site
    Fresh Meadows, New York 11365, United States
    Recruiting
  • Study Site
    New York, New York 10016, United States
    Recruiting
  • Study Site
    Winston-Salem, North Carolina 27103, United States
    Recruiting
  • Study Site
    Fort Worth, Texas 76110, United States
    Recruiting
  • Study Site
    Houston, Texas 77054, United States
    Recruiting
  • Study Site
    San Antonio, Texas 78212, United States
    Recruiting
  • Study Site
    Van Vleck, Texas 77482, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2026 (actual). Primary completion is estimated for Jun 2027, 17 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2025
First posted
Jan 21, 2026
StartActual
Jan 13, 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
3 sites added. Study Site is now Terminated
Show 3 added (3 United States)
  • Study Site · Detroit, United States
  • Study Site · New Orleans, United States
  • Study Site · Van Vleck, United States
across 3 updates, Oct 15, 2026 – Oct 23, 2026
Show all 3 updates
  1. Oct 23, 2026
    2 sites added
    Show 2 added (2 United States)
    • Study Site · New Orleans, United States
    • Study Site · Van Vleck, United States
  2. Oct 20, 2026
    1 site added
    Show site
    • Study Site · Detroit, United States
    + 1 other change: verification date
  3. Oct 15, 2026
    Study Site is now Terminated

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07355062
Lead sponsor
Renibus Therapeutics, Inc.
Responsible party
Sponsor
First posted
Jan 21, 2026
Start date
Jan 13, 2026
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Oct 23, 2026

Study contacts

Ayla Rasmussen
Contact
arasmussen@renibus.com
443-569-9228

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Veverimer

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