Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD (RESOLVE-CKD)
17 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
60
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Paola Lanza, MD
- Numéro de téléphone: 469-852-9550
- E-mail: paola.lanza@UTSouthwestern.edu
Sauvegarde des contacts de l'étude
- Nom: Alexandra R Hartman
- Numéro de téléphone: 614-420-1186
- E-mail: RESOLVE-CKD@UTSouthwestern.edu
Lieux d'étude
-
-
Texas
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Dallas, Texas, États-Unis, 75390
- University of Texas Southwestern Medical Center
-
Chercheur principal:
- Jing Chen, MD
-
Contact:
- Paola Lanza, MD
- Numéro de téléphone: 469-852-9550
- E-mail: paola.lanza@UTSouthwestern.edu
-
Contact:
- Alexandra R Hartman
- Numéro de téléphone: 214-645-8294
- E-mail: alexandra.hartman@UTSouthwestern.edu
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Low-Dose Colchicine (LoDoCo)
Participants will receive low-dose Colchicine (LoDoCo) in addition to usual care.
|
Intervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily.
Autres noms:
Participants will receive usual care according to standard clinical practice and treating physician discretion.
|
|
Comparateur actif: Usual Care
Participants will receive usual care alone.
|
Participants will receive usual care according to standard clinical practice and treating physician discretion.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Coronary Artery Calcification Agatston Scores
Délai: Baseline, 12 months
|
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.
|
Baseline, 12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Coronary Artery Calcification Volume Scores
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline, 6 months, 12 months
|
Circulating P1NP levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Exploratory: Change in Urine Albumin-to-Creatine Ratio (uACR)
Délai: 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)
Délai: 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)
Délai: Baseline, 6 months, 12 months
|
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.
|
Baseline, 6 months, 12 months
|
|
Exploratory: Change in Toe-Brachial Index (TBI)
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Jing Chen, MD, University of Texas
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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- Tian L, Jaeger BC, Scialla JJ, Budoff MJ, Mehta RC, Jaar BG, Saab G, Dobre MA, Reilly MP, Rader DJ, Townsend RR, Lash JP, Greenland P, Isakova T, Bundy JD; CRIC Study Investigators. Progression of Coronary Artery Calcification and Risk of Clinical Events in CKD: The Chronic Renal Insufficiency Cohort Study. Am J Kidney Dis. 2025 Jan;85(1):67-77.e1. doi: 10.1053/j.ajkd.2024.06.018. Epub 2024 Aug 16.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juillet 2026
Achèvement primaire (Estimé)
1 décembre 2027
Achèvement de l'étude (Estimé)
31 décembre 2027
Dates d'inscription aux études
Première soumission
11 juin 2026
Première soumission répondant aux critères de contrôle qualité
11 juin 2026
Première publication (Réel)
17 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies du système endocrinien
- Maladies osseuses
- Maladies musculo-squelettiques
- Maladies vasculaires
- Maladies cardiovasculaires
- Processus pathologiques
- Troubles nutritionnels
- Maladies urogénitales masculines
- Maladies rénales
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladie chronique
- Attributs de la maladie
- Maladies métaboliques
- Troubles du métabolisme du glucose
- Insuffisance rénale
- Maladies osseuses métaboliques
- Maladies parathyroïdiennes
- Troubles du métabolisme lipidique
- Artériosclérose
- Maladies artérielles occlusives
- Avitaminose
- Maladies de carence
- Malnutrition
- Rachitisme
- Troubles du métabolisme calcique
- Carence en vitamine D
- Calcinose
- Hyperparathyroïdie secondaire
- Hyperparathyroïdie
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Hypertension
- Diabète sucré
- Insuffisance rénale chronique
- Dyslipidémies
- Athérosclérose
- Calcification vasculaire
- Maladie rénale chronique - Trouble minéral et osseux
- Composés hétérocycliques
- Alcaloïdes
- Colchicine
Autres numéros d'identification d'étude
- STU20260896
- 99077 (Autre identifiant: UT Southwestern Medical Center)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
IRB approval is required before sharing IPD.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .