Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD (RESOLVE-CKD)
17 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
60
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Paola Lanza, MD
- Número de telefone: 469-852-9550
- E-mail: paola.lanza@UTSouthwestern.edu
Estude backup de contato
- Nome: Alexandra R Hartman
- Número de telefone: 614-420-1186
- E-mail: RESOLVE-CKD@UTSouthwestern.edu
Locais de estudo
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Texas
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Dallas, Texas, Estados Unidos, 75390
- University of Texas Southwestern Medical Center
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Investigador principal:
- Jing Chen, MD
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Contato:
- Paola Lanza, MD
- Número de telefone: 469-852-9550
- E-mail: paola.lanza@UTSouthwestern.edu
-
Contato:
- Alexandra R Hartman
- Número de telefone: 214-645-8294
- E-mail: alexandra.hartman@UTSouthwestern.edu
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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.
Outros nomes:
Participants will receive usual care according to standard clinical practice and treating physician discretion.
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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Coronary Artery Calcification Agatston Scores
Prazo: 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.
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Baseline, 12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Coronary Artery Calcification Volume Scores
Prazo: 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.
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Baseline, 12 months
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Change in Cardiac Artery Calcification Mass Scores
Prazo: 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
Prazo: Baseline, 6 months, 12 months
|
Circulating klotho levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
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Change in Fetuin A Levels
Prazo: Baseline, 6 months, 12 months
|
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
Prazo: Baseline, 6 months, 12 months
|
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
Prazo: Baseline, 6 months, 12 months
|
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
Prazo: Baseline, 6 months, 12 months
|
Circulating PTH levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
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Change in C-terminal Fibroblast Growth Factor 23 (FGF23) Levels
Prazo: Baseline, 6 months, 12 months
|
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
Prazo: Baseline, 6 months, 12 months
|
Circulating FGF23 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 Bone-Specific Alkaline Phosphatase (BSAP) Levels
Prazo: 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)
Prazo: 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
Prazo: Baseline, 6 months, 12 months
|
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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: Baseline, 6 months, 12 months
|
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
Prazo: 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
Prazo: Baseline, 6 months, 12 months
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Circulating IL-17 levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
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Change in Intact N-Terminal Propeptide of Type I Procollagen (P1NP) Levels
Prazo: Baseline, 6 months, 12 months
|
Circulating P1NP levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Exploratory: Change in Urine Albumin-to-Creatine Ratio (uACR)
Prazo: 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
|
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Exploratory: Change in Estimated Glomerular Filtration Rate (eGFR)
Prazo: Baseline, 6 months, 12 months
|
eGFR values (mL/min/1.73m2)
will be calculated using the NKF-ASN CKD-Epi refit formula.
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Baseline, 6 months, 12 months
|
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Exploratory: Change in Ankle-Brachial Index (ABI)
Prazo: 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)
Prazo: Baseline, 6 months, 12 months
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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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Jing Chen, MD, University of Texas
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de julho de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
11 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de junho de 2026
Primeira postagem (Real)
17 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças do Sistema Endócrino
- Doenças ósseas
- Doenças musculoesqueléticas
- Doenças Vasculares
- Doenças cardiovasculares
- Processos Patológicos
- Distúrbios Nutricionais
- Doenças Urogenitais Masculinas
- Doenças renais
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doença crônica
- Atributos da doença
- Doenças Metabólicas
- Distúrbios do Metabolismo da Glicose
- Insuficiência renal
- Doenças Ósseas Metabólicas
- Doenças da Paratireoide
- Distúrbios do metabolismo lipídico
- Arteriosclerose
- Doenças Arteriais Oclusivas
- Avitaminose
- Doenças de Deficiência
- Desnutrição
- Raquitismo
- Distúrbios do Metabolismo do Cálcio
- Deficiência de Vitamina D
- Calcinose
- Hiperparatireoidismo Secundário
- Hiperparatireoidismo
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Hipertensão
- Diabetes Mellitus
- Insuficiência Renal Crônica
- Dislipidemias
- Aterosclerose
- Calcificação Vascular
- Doença Renal Crônica - Desordem Mineral e Óssea
- Compostos heterocíclicos
- Alcalóides
- Colchicina
Outros números de identificação do estudo
- STU20260896
- 99077 (Outro identificador: UT Southwestern Medical Center)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
IRB approval is required before sharing IPD.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Sim
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .