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Et studie til evaluering af effektiviteten og sikkerheden af veverimer til behandling af metabolisk acidose

20. oktober 2026 opdateret af: Renibus Therapeutics, Inc.

En fase 3, randomiseret, dobbeltblindet undersøgelse til vurdering af effektiviteten og sikkerheden af veverimer hos voksne med CKD og metabolisk acidose (REVIVE-undersøgelsen)

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo

Group 2: 9 g PBO BID
Eksperimentel: Veverimer
Medicin: Veverimer

Group 1: 9 g veverimer BID

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Effekten af Veverimer ved måling af ændring i serum bikarbonatkoncentration (SBC)
Tidsramme: Besøg: Screening til dag 168
Besøg: Screening til dag 168
Effektiviteten af Veverimer i at forbedre fysisk præstation vurderet ved 5-gange siddende-rejsende-testen (STS5).
Tidsramme: Besøg: Screening til dag 168
Besøg: Screening til dag 168

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Renibus Therapeutics, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. januar 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

25. november 2025

Først indsendt, der opfyldte QC-kriterier

19. januar 2026

Først opslået (Faktiske)

21. januar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • REN-012

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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