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

NCT07654231 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: STU2026089699077
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease Mineral and Bone Disorder; Hypertension; Diabetes; Dyslipidemia; Atherosclerotic Cardiovascular Disease (ASCVD); Chronic Kidney Disease (Stage 3)

Keywords

Chronic Kidney Disease; CVD; vascular calcification; Colchicine

Outcome Measures

Primary Outcomes (1)

• Change in Coronary Artery Calcification Agatston Scores

  Agatston scores (Agatston units) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.

  Baseline, 12 months

Secondary Outcomes (20)

• Change in Coronary Artery Calcification Volume Scores

  Baseline, 12 months

• Change in Cardiac Artery Calcification Mass Scores

  Baseline, 12 months

• Change in Serum Klotho Levels

  Baseline, 6 months, 12 months

• Change in Fetuin A Levels

  Baseline, 6 months, 12 months

• Change in Serum Phosphate levels

  Baseline, 6 months, 12 months

Other Outcomes (4)

• Exploratory: Change in Urine Albumin-to-Creatine Ratio (uACR)

  Baseline, 6 months, 12 months

• Exploratory: Change in Estimated Glomerular Filtration Rate (eGFR)

  Baseline, 6 months, 12 months

• Exploratory: Change in Ankle-Brachial Index (ABI)

  Baseline, 6 months, 12 months

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Participants will receive LoDoCo (colchicine 0.5mg) in addition to usual care.

Drug: Low-dose colchicine; Other: Usual Care

Control Group

ACTIVE COMPARATOR

Participants will receive usual care alone.

Other: Usual Care

Interventions

Low-dose colchicine DRUG

Intervention group will receive LoDoCo (colchicine 0.5mg), oral, once daily.

Also known as: LoDoCo

Intervention Group

Usual Care OTHER

Participants will receive usual care alone according to standard clinical practice and treating physician discretion.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Gender Eligibility Details: female or male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (37)

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MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder; Hypertension; Diabetes Mellitus; Dyslipidemias; Atherosclerosis; Renal Insufficiency, Chronic; Vascular Calcification

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Lipid Metabolism Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Renal Insufficiency; Calcinosis

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Jing Chen, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra R Hartman

CONTACT

614-420-1186; RESOLVE-CKD@UTSouthwestern.edu

Paola Lanza, MD

CONTACT

469-852-9550; paola.lanza@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)