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Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD)

11. juni 2026 opdateret af: Jing Chen, University of Texas Southwestern Medical Center

Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)

The overall objective of this pilot randomized clinical trial is to determine whether LoDoCo improves vascular disease including vascular calcification, peripheral arterial disease(PAD), and CKD-MBD biomarkers in patients with CKD stage 3 over a 12-month intervention period, compared with usual care.

Successful completion of this study will generate critical preliminary data to support a larger clinical trial aimed at evaluating inflammation-targeted therapies to mitigate CKD-MBD, including vascular calcification and related PAD, as well as osteoporosis, ultimately reducing cardiovascular events and mortality in patients with CKD. Additionally, this work has the potential to redefine the diagnostic framework for CKD-MBD.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

We will conduct a randomized, open-label, outcome blinded mechanistic clinical trial in 60 adults with stage 3 CKD who have hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD).

We will evaluate whether LoDoCo improves CAC and MBD over 12 months in patients with CKD, eGFR ≥30 to 59 mL/min/1.73 m², and uACR ≥200 mg/g. Sixty participants with CKD stage 3 and increased risk of, or established, ASCVD will be randomized 1:1 to receive LoDoCo plus usual care or usual care alone. Primary outcomes include changes in Agaston scores assessed by CCT from baseline to 12 months, second outcomes include changes in the individual biomarkers of MBD and VC from baseline and 12 months. Exploratory outcomes include changes in uACR, eGFR, ABI, and TBI. Safety and tolerability will also be evaluated. Participants will be followed at baseline, 6 months, and 12 months for data collection, with an in-person visit at 1 month for safety evaluation. Additional safety assessments for side effects may be conducted by phone at any time.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Fase 2

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Men and women aged 18-<70 years of all race/ethnicity groups
  • CKD stage 3 (eGFR >30 to 59 ml/min/1.73m2)
  • uACR ≥ 200 mg/g
  • CAC Agatston score ≥30
  • Hypertension, diabetes, dyslipidemia, or established ASCVD (CAD, ischemic stroke, and peripheral artery disease), defined by self-report, ICD-10 codes, or the use of medications for these conditions.
  • Ability to provide informed consent.

Exclusion Criteria:

  • Current colchicine therapy
  • Hepatic disease
  • Any clinically active diagnosed infection requiring systemic antimicrobial therapy, positive microbiologic evidence of infection, or infection-related hospitalization within 30 days prior to study enrollment.
  • Immunosuppression
  • Current use of chemotherapy drugs or active cancer
  • Pregnancy/breastfeeding
  • Hospitalized within the past 6 months
  • Allergic/intolerance to colchicine
  • Use of p-gp inhibitor ( such as Verapamil, Quinidine, Amiodarone, Ritonavir, Lopinavir/ritonavir, Saquinavir, Nelfinavir)
  • Use of strong CYP3A4 inhibitors (such as Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Clarithromycin, Erythromycin)
  • HIV infection
  • Gout attack ≥ 1 time per year
  • Severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men)
  • eGFR <30 ml/min/1.73m2
  • uACR <200 mg/g
  • WBC <3.0 x109/L
  • AST or ALT > 3 x Upper Limit of Normal (ULN)
  • Total bilirubin >2 x ULN
  • Glucose >300mg/dl
  • Uses nicotine products or other recreational drugs
  • Unable to read or speak English
  • Participant in other conflict clinical trial,
  • Unable to complete the study measurements
  • Unable to undergo to CT or DXA scans
  • Unsafe to participate in this study per investigator's judgement.

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Intervention Group
Participants will receive LoDoCo (colchicine 0.5mg) in addition to usual care.
Medicin: Low-dose colchicine
Intervention group will receive LoDoCo (colchicine 0.5mg), oral, once daily.
Andre navne:
  • LoDoCo
Andet: Usual Care
Participants will receive usual care alone according to standard clinical practice and treating physician discretion.
Aktiv komparator: Control Group
Participants will receive usual care alone.
Andet: Usual Care
Participants will receive usual care alone according to standard clinical practice and treating physician discretion.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Coronary Artery Calcification Agatston Scores
Tidsramme: Baseline, 12 months
Agatston scores (Agatston units) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
Baseline, 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Coronary Artery Calcification Volume Scores
Tidsramme: Baseline, 12 months
Change in Coronary Artery Calcification volume (mm3) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
Baseline, 12 months
Change in Cardiac Artery Calcification Mass Scores
Tidsramme: Baseline, 12 months
Change in Cardiac Artery Calcification Mass (mg) score will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
Baseline, 12 months
Change in Serum Klotho Levels
Tidsramme: Baseline, 6 months, 12 months
Circulating klotho levels (pg/mL) will be measured using standard clinical laboratory assays.
Baseline, 6 months, 12 months
Change in Fetuin A Levels
Tidsramme: Baseline, 6 months, 12 months
Circulating fetuin A levels (ng/mL) will be measured using standard clinical laboratory assays
Baseline, 6 months, 12 months
Change in Serum Phosphate levels
Tidsramme: Baseline, 6 months, 12 months
Circulating serum phosphate levels (mg/dL) will be measured using standard clinical laboratory assays.
Baseline, 6 months, 12 months
Change in Serum Calcium Levels
Tidsramme: Baseline, 6 months, 12 months
Circulating serum calcium levels (mg/dL) will be measured using standard clinical laboratory assays.
Baseline, 6 months, 12 months
Change in Parathyroid Hormone (PTH) levels
Tidsramme: Baseline, 6 months, 12 months
Circulating PTH levels (pg/mL) will be measured using standard clinical laboratory assays.
Baseline, 6 months, 12 months
Change in C-terminal Fibroblast Growth Factor 23 (FGF23) Levels
Tidsramme: Baseline, 6 months, 12 months
Circulating C-terminal FGF23 levels (RU/mL) will be measured using standard clinical laboratory assays.
Baseline, 6 months, 12 months
Change in Fibroblast Growth Factor 23 (FGF23) Levels
Tidsramme: Baseline, 6 months, 12 months
Circulating FGF23 levels (pg/mL) will be measured using standard clinical laboratory assays.
Baseline, 6 months, 12 months
Change in Bone-Specific Alkaline Phosphatase (BSAP) Levels
Tidsramme: Baseline, 6 months, 12 months
Circulating serum BSAP levels (ug/L) will be measured using standard clinical laboratory assays.
Baseline, 6 months, 12 months
Change in C-terminal Telopeptide of Type I Collagen (CTX)
Tidsramme: Baseline, 6 months, 12 months
Circulating CTX levels (ng/mL) will be measured using standard clinical laboratory assays.
Baseline, 6 months, 12 months
Change in Tartrate-Resistant Acid Phosphatase 5b (TRAP-5b) Levels
Tidsramme: Baseline, 6 months, 12 months
Circulating TRAP-5b levels (U/L) will be measured using standard clinical laboratory assays
Baseline, 6 months, 12 months
Change in Sclerostin Levels
Tidsramme: Baseline, 6 months, 12 months
Circulating sclerostin levels (pg/mL) will be measured using standard clinical laboratory assays.
Baseline, 6 months, 12 months
Change in Lumbar Spine Bone Mineral Density (BMD)
Tidsramme: Baseline, 12 months
BMD at the lumbar spine (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
Baseline, 12 months
Change in Hip Bone Mineral Density (BMD)
Tidsramme: Baseline, 12 months
BMD at the hip (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
Baseline, 12 months
Change in Radius Bone Mineral Density (BMD)
Tidsramme: Baseline, 12 months
BMD at the radius (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard man
Baseline, 12 months
Change in Interleukin-6 (IL-6) Levels
Tidsramme: Baseline, 6 months, 12 months
Circulating IL-6 levels (pg/mL) will be measured using standard clinical laboratory assays.
Baseline, 6 months, 12 months
Change in Soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) Levels
Tidsramme: Baseline, 6 months, 12 months
Circulating sTNFR1 levels (pg/mL) will be measured using standard clinical laboratory assays.
Baseline, 6 months, 12 months
Change in Interleukin-17 (IL-17) Levels
Tidsramme: Baseline, 6 months, 12 months
Circulating IL-17 levels (pg/mL) will be measured using standard clinical laboratory assays.
Baseline, 6 months, 12 months
Change in Intact N-Terminal Propeptide of Type I Procollagen (P1NP) Levels
Tidsramme: Baseline, 6 months, 12 months
Circulating P1NP levels (pg/mL) will be measured using standard clinical laboratory assays.
Baseline, 6 months, 12 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exploratory: Change in Urine Albumin-to-Creatine Ratio (uACR)
Tidsramme: Baseline, 6 months, 12 months
Circulating urinary albumin and creatine levels (mg/dL) will be measured using standard clinical laboratory assays.
Baseline, 6 months, 12 months
Exploratory: Change in Estimated Glomerular Filtration Rate (eGFR)
Tidsramme: Baseline, 6 months, 12 months
eGFR values (mL/min/1.73m2) will be calculated using the NKF-ASN CKD-Epi refit formula.
Baseline, 6 months, 12 months
Exploratory: Change in Ankle-Brachial Index (ABI)
Tidsramme: Baseline, 6 months, 12 months
ABI will be measured using semi-automated validated device (simpleABI-600CL).
Baseline, 6 months, 12 months
Exploratory: Change in Toe-Brachial Index (TBI)
Tidsramme: Baseline, 6 months, 12 months
TBI will be measured using semi-automated validated device (simpleABI-600CL).
Baseline, 6 months, 12 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Texas Southwestern Medical Center

Efterforskere

  • Ledende efterforsker: Jing Chen, MD, University of Texas

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

11. juni 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STU20260896
  • 99077 (Anden identifikator: UT Southwestern Medical Center)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

IRB approval is required before sharing IPD.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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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