Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD (RESOLVE-CKD)
keskiviikko 17. kesäkuuta 2026 päivittänyt: 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 low-dose Colchicine (LoDoCo) improves vascular disease including vascular calcification, peripheral arterial disease (PAD), and chronic kidney disease-mineral and bone disorder (CKD-MBD) biomarkers in patients with chronic kidney disease (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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
The investigators will conduct a randomized, open-label, outcome blinded mechanistic clinical trial in 60 adults with stage 3 chronic kidney disease (CKD) who have hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD).
The investigators will evaluate whether low-dose Colchicine (LoDoCo) improves coronary artery calcification (CAC) and mineral and bone disorders (MBD) over 12 months in patients with CKD, eGFR ≥30 to 59 mL/min/1.73 m², and urine albumin-to-creatinine ratio (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 cardiac computed tomography (CCT) from baseline to 12 months, second outcomes include changes in the individual biomarkers of MBD and vascular calcification (VC) from baseline and 12 months. Exploratory outcomes include changes in uACR, estimated glomerular filtration rate (eGFR), ankle-brachial index (ABI), and toe-brachial index (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.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
60
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Paola Lanza, MD
- Puhelinnumero: 469-852-9550
- Sähköposti: paola.lanza@UTSouthwestern.edu
Tutki yhteystietojen varmuuskopiointi
- Nimi: Alexandra R Hartman
- Puhelinnumero: 614-420-1186
- Sähköposti: RESOLVE-CKD@UTSouthwestern.edu
Opiskelupaikat
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-
Texas
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Dallas, Texas, Yhdysvallat, 75390
- University of Texas Southwestern Medical Center
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Päätutkija:
- Jing Chen, MD
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Ottaa yhteyttä:
- Paola Lanza, MD
- Puhelinnumero: 469-852-9550
- Sähköposti: paola.lanza@UTSouthwestern.edu
-
Ottaa yhteyttä:
- Alexandra R Hartman
- Puhelinnumero: 214-645-8294
- Sähköposti: alexandra.hartman@UTSouthwestern.edu
-
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Inclusion Criteria:
- Men and women aged 18-<70 years of all race/ethnicity groups
- CKD stage 3 (estimated glomerular filtration rate (eGFR) >30 to 59 ml/min/1.73m2)
- Urine albumin-to-creatinine ratio (uACR) ≥ 200 mg/g
- Cardiac artery calcification (CAC) Agatston score ≥30
- Hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD) (coronary artery disease (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-glycoprotein (p-gp) inhibitor (such as Verapamil, Quinidine, Amiodarone, Ritonavir, Lopinavir/ritonavir, Saquinavir, Nelfinavir)
- Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (such as Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Clarithromycin, Erythromycin)
- Human immunodeficiency virus (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
- White blood cell count (WBC) <3.0 x109/L
- Aspartate aminotransferase (AST) or alanine aminotransferase (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 computed tomography (CT) or dual-energy X-ray absorptiometry (DXA) scans
- Unsafe to participate in this study per investigator's judgement.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Active Comparator: Low-Dose Colchicine (LoDoCo)
Participants will receive low-dose Colchicine (LoDoCo) in addition to usual care.
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Intervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily.
Muut nimet:
Participants will receive usual care according to standard clinical practice and treating physician discretion.
|
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Active Comparator: Usual Care
Participants will receive usual care alone.
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Participants will receive usual care according to standard clinical practice and treating physician discretion.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Coronary Artery Calcification Agatston Scores
Aikaikkuna: Baseline, 12 months
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Agatston scores (Agatston units) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
Coronary artery calcification will be quantified using the Coronary Artery Calcium (CAC) Agatston Score.
Scores range from 0 Agatston units (no detectable coronary calcification), 1-99 Agatston units (mild calcification), 100-399 Agatston units (moderate calcification), and ≥400 Agatston units (severe calcification, high atherosclerotic burden).
Higher scores indicate greater coronary artery calcification and are associated with worse outcomes.
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Baseline, 12 months
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Coronary Artery Calcification Volume Scores
Aikaikkuna: Baseline, 12 months
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Change in Coronary Artery Calcification volume (mm3) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
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Baseline, 12 months
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Change in Cardiac Artery Calcification Mass Scores
Aikaikkuna: Baseline, 12 months
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Change in Cardiac Artery Calcification Mass (mg) score will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
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Baseline, 12 months
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Change in Serum Klotho Levels
Aikaikkuna: Baseline, 6 months, 12 months
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Circulating klotho levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Fetuin A Levels
Aikaikkuna: Baseline, 6 months, 12 months
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Circulating fetuin A levels (ng/mL) will be measured using standard clinical laboratory assays
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Baseline, 6 months, 12 months
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Change in Serum Phosphate levels
Aikaikkuna: Baseline, 6 months, 12 months
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Circulating serum phosphate levels (mg/dL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Serum Calcium Levels
Aikaikkuna: Baseline, 6 months, 12 months
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Circulating serum calcium levels (mg/dL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Change in Parathyroid Hormone (PTH) levels
Aikaikkuna: Baseline, 6 months, 12 months
|
Circulating PTH levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in C-terminal Fibroblast Growth Factor 23 (FGF23) Levels
Aikaikkuna: Baseline, 6 months, 12 months
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Circulating C-terminal FGF23 levels (RU/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Fibroblast Growth Factor 23 (FGF23) Levels
Aikaikkuna: Baseline, 6 months, 12 months
|
Circulating FGF23 levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
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Change in Bone-Specific Alkaline Phosphatase (BSAP) Levels
Aikaikkuna: Baseline, 6 months, 12 months
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Circulating serum BSAP levels (ug/L) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in C-terminal Telopeptide of Type I Collagen (CTX)
Aikaikkuna: Baseline, 6 months, 12 months
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Circulating CTX levels (ng/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Change in Tartrate-Resistant Acid Phosphatase 5b (TRAP-5b) Levels
Aikaikkuna: Baseline, 6 months, 12 months
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Circulating TRAP-5b levels (U/L) will be measured using standard clinical laboratory assays
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Baseline, 6 months, 12 months
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Change in Sclerostin Levels
Aikaikkuna: Baseline, 6 months, 12 months
|
Circulating sclerostin levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Change in Lumbar Spine Bone Mineral Density (BMD)
Aikaikkuna: Baseline, 12 months
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BMD at the lumbar spine (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
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Baseline, 12 months
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Change in Hip Bone Mineral Density (BMD)
Aikaikkuna: Baseline, 12 months
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BMD at the hip (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
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Baseline, 12 months
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Change in Radius Bone Mineral Density (BMD)
Aikaikkuna: Baseline, 12 months
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BMD at the radius (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard man
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Baseline, 12 months
|
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Change in Interleukin-6 (IL-6) Levels
Aikaikkuna: Baseline, 6 months, 12 months
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Circulating IL-6 levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) Levels
Aikaikkuna: Baseline, 6 months, 12 months
|
Circulating sTNFR1 levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
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Change in Interleukin-17 (IL-17) Levels
Aikaikkuna: Baseline, 6 months, 12 months
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Circulating IL-17 levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
|
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Change in Intact N-Terminal Propeptide of Type I Procollagen (P1NP) Levels
Aikaikkuna: Baseline, 6 months, 12 months
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Circulating P1NP levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Exploratory: Change in Urine Albumin-to-Creatine Ratio (uACR)
Aikaikkuna: Baseline, 6 months, 12 months
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Circulating urinary albumin and creatine levels (mg/dL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
|
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Exploratory: Change in Estimated Glomerular Filtration Rate (eGFR)
Aikaikkuna: 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
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Exploratory: Change in Ankle-Brachial Index (ABI)
Aikaikkuna: Baseline, 6 months, 12 months
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ABI will be measured using semi-automated validated device (simpleABI-600CL).
ABI values range from ≤0.90 (Peripheral artery disease), 0.91-0.99
(borderline), 1.00-1.40
(normal).
ABI values >1.40 indicate non-compressible arteries, suggestive of arterial stiffness or medial calcification.
Both ABI values ≤0.90 and >1.40 are associated with worse outcomes.
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Baseline, 6 months, 12 months
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Exploratory: Change in Toe-Brachial Index (TBI)
Aikaikkuna: Baseline, 6 months, 12 months
|
TBI will be measured using semi-automated validated device (simpleABI-600CL).
TBI values range from ≥0.70 (normal), 0.64-0.69
(borderline), and <0.40-0.50
(severe distal arterial disease/critical ischemia range).
TBI values <0.70 is a commonly used threshold suggestive of peripheral artery disease.
Lower TBI values are associated with worse outcomes.
|
Baseline, 6 months, 12 months
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Tutkijat
- Päätutkija: Jing Chen, MD, University of Texas
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
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Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Urogenitaaliset sairaudet
- Endokriinisen järjestelmän sairaudet
- Luun sairaudet
- Tuki- ja liikuntaelinten sairaudet
- Verisuonisairaudet
- Sydän-ja verisuonitaudit
- Patologiset prosessit
- Ravitsemushäiriöt
- Miesten urogenitaaliset sairaudet
- Munuaissairaudet
- Urologiset sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet ja raskauden komplikaatiot
- Krooninen sairaus
- Sairauden ominaisuudet
- Metaboliset sairaudet
- Glukoosiaineenvaihduntahäiriöt
- Munuaisten vajaatoiminta
- Luusairaudet, aineenvaihdunta
- Lisäkilpirauhasen sairaudet
- Lipidiaineenvaihduntahäiriöt
- Valtimotauti
- Valtimon tukossairaudet
- Avitaminoosi
- Puutostaudit
- Aliravitsemus
- Riisitauti
- Kalsiumin aineenvaihduntahäiriöt
- D-vitamiinin puutos
- Kalsinoosi
- Lisäkilpirauhasen liikatoiminta, toissijainen
- Kilpirauhasen liikatoiminta
- Patologiset tilat, merkit ja oireet
- Ravitsemukselliset ja aineenvaihduntataudit
- Hypertensio
- Diabetes mellitus
- Munuaisten vajaatoiminta, krooninen
- Dyslipidemiat
- Ateroskleroosi
- Verisuonten kalkkiutuminen
- Krooninen munuaissairaus – mineraali- ja luusairaus
- Heterosykliset yhdisteet
- Alkaloidit
- Kolkisiini
Muut tutkimustunnusnumerot
- STU20260896
- 99077 (Muu tunniste: UT Southwestern Medical Center)
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IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
Lääke- ja laitetiedot, tutkimusasiakirjat
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