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En studie for å evaluere effektiviteten og sikkerheten til Veverimer for behandling av metabolsk acidose

20. oktober 2026 oppdatert av: Renibus Therapeutics, Inc.

En fase 3, randomisert, dobbeltblind studie for å evaluere effektiviteten og sikkerheten til Veverimer hos voksne med CKD og metabolsk acidose (REVIVE-studien)

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • California
      • Chula Vista, California, Forente stater, 91910
        • Rekruttering
        • Study Site
      • Los Angeles, California, Forente stater, 90022
        • Rekruttering
        • Study Site
      • Sacramento, California, Forente stater, 95817
        • Rekruttering
        • Study Site
      • San Diego, California, Forente stater, 92111
        • Rekruttering
        • Study Site
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Rekruttering
        • Study Site
    • Delaware
      • Newark, Delaware, Forente stater, 19713
        • Rekruttering
        • Study Site
    • Florida
      • Edgewater, Florida, Forente stater, 32132
        • Rekruttering
        • Study Site
      • Margate, Florida, Forente stater, 33063
        • Rekruttering
        • Study Site
      • Miami Springs, Florida, Forente stater, 33166
        • Rekruttering
        • Study Site
      • Orlando, Florida, Forente stater, 32806
        • Rekruttering
        • Study Site
    • Georgia
      • Augusta, Georgia, Forente stater, 30904
        • Avsluttet
        • Study Site
    • Idaho
      • Boise, Idaho, Forente stater, 83706
        • Rekruttering
        • Study Site
      • Chubbuck, Idaho, Forente stater, 83201
        • Rekruttering
        • Study Site
      • Idaho Falls, Idaho, Forente stater, 83401
        • Rekruttering
        • Study Site
    • Illinois
      • Chicago, Illinois, Forente stater, 60643
        • Rekruttering
        • Study Site
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Rekruttering
        • Study Site
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40205
        • Rekruttering
        • Study Site
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
        • Rekruttering
        • Study Site
    • Michigan
      • Detroit, Michigan, Forente stater, 48202
        • Rekruttering
        • Study Site
      • Pontiac, Michigan, Forente stater, 48341
        • Rekruttering
        • Study Site
    • Missouri
      • Kansas City, Missouri, Forente stater, 64111
        • Rekruttering
        • Study Site
    • New York
      • Fresh Meadows, New York, Forente stater, 11365
        • Rekruttering
        • Study Site
      • New York, New York, Forente stater, 10016
        • Rekruttering
        • Study Site
    • North Carolina
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Rekruttering
        • Study Site
    • Texas
      • Fort Worth, Texas, Forente stater, 76110
        • Rekruttering
        • Study Site
      • Houston, Texas, Forente stater, 77054
        • Rekruttering
        • Study Site
      • San Antonio, Texas, Forente stater, 78212
        • Rekruttering
        • Study Site
      • Van Vleck, Texas, Forente stater, 77482
        • Rekruttering
        • Study Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Have provided written informed consent prior to participation in the study.
  • Male or female participants 18 years of age or older.
  • Diagnosed with CKD (eGFR < 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 childbearing potential must have a negative pregnancy test and agree to abstinence or to use contraception.

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. Clinically significant 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 autoimmune 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 metastatic malignancy 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 hemoglobin < 9 g/dL.

  • Low bicarbonate value(s) at time of screening that are due to underlying primary respiratory alkalosis.

  • Investigational 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) hemoglobin A1C 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Legemiddel: Placebo

Group 2: 9 g PBO BID
Eksperimentell: Veverimer
Legemiddel: Veverimer

Group 1: 9 g veverimer BID

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Effekt av Veverimer ved å måle endring i serum bikarbonatkonsentrasjon (SBC)
Tidsramme: Besøk: Screening til dag 168
Besøk: Screening til dag 168
Effekt av Veverimer i å forbedre fysisk ytelse som vurdert ved Sit-to-Stand 5 ganger-testen (STS5).
Tidsramme: Besøk: Screening til dag 168
Besøk: Screening til dag 168

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].
Tidsramme: Visits: Screening to Day 168
Visits: Screening to Day 168
Efficacy of Veverimer in achieving SBC and responder thresholds.
Tidsramme: Visits: Screening to Day 168

Change from baseline in SBC. Achievement of SBC thresholds (> 4 mmol/L increase from baseline and/or > 23 mmol/L).
Visits: Screening to Day 168
Performance outcomes (PerfO).
Tidsramme: Visits: Screening to Day 168

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.
Visits: Screening to Day 168
Frailty and muscle mass assessment.
Tidsramme: Visits: Screening to Day 168

Change in performance on 6-minute walk test 6MWT.
Visits: Screening to Day 168

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Renibus Therapeutics, Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. januar 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

25. november 2025

Først innsendt som oppfylte QC-kriteriene

19. januar 2026

Først lagt ut (Faktiske)

21. januar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • REN-012

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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