Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD (RESOLVE-CKD)

June 17, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low-Dose Colchicine (LoDoCo)
Participants will receive low-dose Colchicine (LoDoCo) in addition to usual care.
Drug: Low-dose Colchicine at 0.5mg daily
Intervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily.
Other Names:
  • LoDoCo
Other: Usual Care
Participants will receive usual care according to standard clinical practice and treating physician discretion.
Active Comparator: Usual Care
Participants will receive usual care alone.
Other: Usual Care
Participants will receive usual care according to standard clinical practice and treating physician discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Coronary Artery Calcification Agatston Scores
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Coronary Artery Calcification Volume Scores
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline, 6 months, 12 months
Circulating P1NP levels (pg/mL) will be measured using standard clinical laboratory assays.
Baseline, 6 months, 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory: Change in Urine Albumin-to-Creatine Ratio (uACR)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Jing Chen, MD, University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 11, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU20260896
  • 99077 (Other Identifier: UT Southwestern Medical Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IRB approval is required before sharing IPD.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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