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Chronic Kidney Disease Mineral and Bone DisorderPhase 2RESOLVE-CKDNCT07654231

REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial

A Phase 2 study testing Low-dose Colchicine at 0.5mg daily in people with Chronic Kidney Disease Mineral and Bone Disorder and Cognitive Function, run by University of Texas Southwestern Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This pilot randomized, open-label, outcome blinded clinical trial is to evaluate the preliminary effects of low-dose Colchicine (LoDoCo) on coronary artery calcification (CAC) progression in adults with chronic kidney disease (CKD) and existing coronary artery calcification. Read more about this study

Who is it for?
Ages 30 to 69 years
What is being tested?
Low-dose Colchicine at 0.5mg daily
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
30 Oct 2026to 1 May 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women aged 30-<70 years of all race/ethnicity groups
  • Chronic kidney disease (CKD) stage 3 (estimated glomerular filtration rate (eGFR) 30 to <60 ml/min/1.73m2) or eGFR ≥60 and Urine albumin-to-creatinine ratio (uACR) ≥ 30 mg/g
  • Cardiac artery calcification (CAC) Agatston score ≥100-1000
  • Ability to provide informed consent.

Who cannot join

  • Current Colchicine therapy
  • Hepatic disease
  • Established peripheral arterial disease (PAD) defined by self-report or ICD-10 codes
  • Congestive heart failure classified as New York Heart Association (NYHA) Functional class III or IV
  • Uncontrolled atrial fibrillation with resting heart rate > 100 beats/min
  • Dementia defined by self-report or ICD-10 codes (F01-F03)
Show all 29Show fewer
  • Alzheimer's disease defined by self-report or ICD-10 codes (G30)
  • 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, including the use of immunosuppressive medications
  • 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
  • White blood cell count (WBC) <3.0 x10^9/L
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x Upper Limit of Normal (ULN)
  • Total bilirubin >2 x ULN
  • Glucose >300mg/dL
  • Uses recreational drugs
  • Participant in other conflict clinical trial
  • Unable to complete the study measurements
  • Unable to undergo to computed tomography (CT)
  • Unsafe to participate in this study per investigator's judgement
  • Unable to read and speak English or Spanish

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alexandra R Hartman contact

614-420-1186

RESOLVE-CKD@UTSouthwestern.edu

Paola Lanza, MD contact

469-852-9550

paola.lanza@UTSouthwestern.edu

United States1 site

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Alexandra R Hartman, 214-645-8294, alexandra.hartman@UTSouthwestern.edu

    Paola Lanza, MD, 469-852-9550, paola.lanza@UTSouthwestern.edu

Other trials in United States

About this study

Official title: REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)

This pilot randomized, open-label, outcome blinded clinical trial is to evaluate the preliminary effects of low-dose Colchicine (LoDoCo) on coronary artery calcification (CAC) progression in adults with chronic kidney disease (CKD) and existing coronary artery calcification. Sixty participants will be randomized 1:1 to received LoDoCo plus usual care or usual care lone and followed for 24 months.

The primary objective is to evaluate the effect of LoDoCo on CAC progression measured by ECG-gates noncontrast cardiac computed tomography (CT). Exploratory outcomes include valvular calcification, bone mineral density, inflammatory, vascular, and miner-bone biomarkers, cognitive function, Alzheimer's disease biomarkers, peripheral arterial disease measures, kidney biomarkers, and participant-reported measures of treatment acceptability, adherence, and adverse effects.

Read the detailed description

The investigators will conduct a randomized, open-label, outcome-blinded, clinical trial in 60 adults with chronic kidney disease (CKD) and existing coronary artery calcification (CAC) Agatston scores of ≥100-1000. Participants will be randomized 1:1 to receive low-dose Colchicine (LoDoCo) plus usual care or usual care alone for 24 months.

The primary objective is to evaluate the effect of LoDoCo on CAC progression over 24 months. CAC will be assessed by ECG-gated noncontrast cardiac computed tomography (CT). Outcomes will include Agatston score and calcium volume. The study will estimate variance, baseline-to-follow-up correlations, and other parameters needed to inform future sample size, treatment duration, and endpoint selection.

Exploratory objectives include evaluating the effects of LoDoCo on aortic valve and mitral annular calcification, CT-derived vertebral bone mineral density, inflammatory biomarkers, vascular calcification biomarkers, and miner-bone metabolism biomarkers. Additional exploratory analyses will examine cognitive function, Alzheimer's disease biomarkers, peripheral arterial disease measures including ankle-brachial index (ABI) and toe-brachial index (TBI), and kidney outcomes including albumin-creatine ratio (uACR) and estimated glomerular filtration rate (eGFR).

Participant experience with LoDoCo will also be evaluated through assessment of treatment acceptability, adherence, adverse effects, and barriers and facilitators to study participation and retention.

Participants will be followed at baseline, 6 months, 12 months, 18 months, and 24 months for data collection. Participants assigned to the intervention group will undergo additional safety monitoring, including laboratory assessments, throughout the study period.

Being tested
Low-dose Colchicine at 0.5mg daily, Usual Care
Keywords
Chronic Kidney Disease, CVD, Colchicine, Cognitive function, Vascular calcification
Medical subject headings
Chronic Kidney Disease-Mineral and Bone Disorder, Vascular Calcification, Calcinosis, Bone Diseases, Peripheral Arterial Disease, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-dose Colchicine at 0.5mg dailyDrug

    Also called LoDoCo

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

  • Usual CareOther

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

Study groups in NCT07654231
Study groupRoleWhat they receive
Low-Dose Colchicine (LoDoCo)Active comparatorParticipants will receive low-dose Colchicine (LoDoCo) in addition to usual care.
Receives: Drug: Low-dose Colchicine at 0.5mg daily; Other: Usual Care
Usual CareActive comparatorParticipants will receive usual care alone.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Coronary Artery Calcification Agatston Scores

    Agatston scores (Agatston units) will be measured by ECG-gated 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.

    Measured: Baseline, 12 months, 24 months

  2. Change in Coronary Artery Calcification Volume Scores

    Change in Coronary Artery Calcification volume (mm3) will be measured by ECG-gates non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.

    Measured: Baseline, 12 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion1 May 2029 (estimated)
  4. Study completion1 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07654231
Sponsor's protocol ID
STU20260896
Other IDs
99077
Acronym
RESOLVE-CKD
Status last verified
Oct 2026
First submitted
11 Jun 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IRB approval is required before sharing IPD.

Publications

  • Kurella Tamura M, Tam K, Vittinghoff E, Raj D, Sozio SM, Rosas SE, Makos G, Lora C, He J, Go AS, Hsu CY, Yaffe K; CRIC Study Investigators. Inflammatory Markers and Risk for Cognitive Decline in Chronic Kidney Disease: The CRIC Study. Kidney Int Rep. 2017 Mar;2(2):192-200. doi: 10.1016/j.ekir.2016.10.007. Epub 2016 Oct 31.

    PubMed 28439566

  • Huang Z, Yaffe K, Li C, Xiao C, Pan Y, Sun X, Anderson AH, He J, Jaar BG, Han H, Kiryluk K, Rahman M, Rao P, Ricardo AC, Shah VO, Srivastava A, Taliercio JJ, Kurella Tamura M, Unruh ML, Weir MR, Lash JP, Bazzano LA, Chen J, Mills KT, Kelly TN; Chronic Renal Insufficiency Cohort (CRIC) Study Investigators. Chronic Kidney Disease Severity and Risk of Cognitive Impairment. JAMA Netw Open. 2026 Feb 2;9(2):e2559834. doi: 10.1001/jamanetworkopen.2025.59834.

    PubMed 41701494

  • Cunningham C, Hennessy E. Co-morbidity and systemic inflammation as drivers of cognitive decline: new experimental models adopting a broader paradigm in dementia research. Alzheimers Res Ther. 2015 Mar 24;7(1):33. doi: 10.1186/s13195-015-0117-2. eCollection 2015.

    PubMed 25802557

  • Ndumele CE, Neeland IJ, Tuttle KR, Chow SL, Mathew RO, Khan SS, Coresh J, Baker-Smith CM, Carnethon MR, Despres JP, Ho JE, Joseph JJ, Kernan WN, Khera A, Kosiborod MN, Lekavich CL, Lewis EF, Lo KB, Ozkan B, Palaniappan LP, Patel SS, Pencina MJ, Powell-Wiley TM, Sperling LS, Virani SS, Wright JT, Rajgopal Singh R, Elkind MSV, Rangaswami J; American Heart Association. A Synopsis of the Evidence for the Science and Clinical Management of Cardiovascular-Kidney-Metabolic (CKM) Syndrome: A Scientific Statement From the American Heart Association. Circulation. 2023 Nov 14;148(20):1636-1664. doi: 10.1161/CIR.0000000000001186. Epub 2023 Oct 9.

    PubMed 37807920

  • Budoff MJ, Bhandari M, Iskander B, Ghanem AK, Kinninger A, Stark J, Garikapati V, Chilukuri S, Hankil V, Krishnan S, Punnanithinont N, Ichikawa K, Kambalapalli S, Hamal S, Lakshmanan S. Effect of colchicine on progression of known coronary atherosclerosis in patients with stable coronary artery disease: EKSTROM randomized placebo controlled trial. Eur Heart J Cardiovasc Imaging. 2026 Mar 27;27(4):682-692. doi: 10.1093/ehjci/jeag028.

    PubMed 41670023

  • Nidorf SM, Fiolet ATL, Mosterd A, Eikelboom JW, Schut A, Opstal TSJ, The SHK, Xu XF, Ireland MA, Lenderink T, Latchem D, Hoogslag P, Jerzewski A, Nierop P, Whelan A, Hendriks R, Swart H, Schaap J, Kuijper AFM, van Hessen MWJ, Saklani P, Tan I, Thompson AG, Morton A, Judkins C, Bax WA, Dirksen M, Alings M, Hankey GJ, Budgeon CA, Tijssen JGP, Cornel JH, Thompson PL; LoDoCo2 Trial Investigators. Colchicine in Patients with Chronic Coronary Disease. N Engl J Med. 2020 Nov 5;383(19):1838-1847. doi: 10.1056/NEJMoa2021372. Epub 2020 Aug 31.

    PubMed 32865380

  • Absalon-Aguilar A, Rull-Gabayet M, Perez-Fragoso A, Mejia-Dominguez NR, Nunez-Alvarez C, Kershenobich-Stalnikowitz D, Sifuentes-Osornio J, Ponce-de-Leon A, Gonzalez-Lara F, Martin-Nares E, Montesinos-Ramirez S, Ramirez-Alemon M, Ramirez-Rangel P, Marquez MF, Plata-Corona JC, Juarez-Vega G, Gomez-Martin D, Torres-Ruiz J. Colchicine Is Safe Though Ineffective in the Treatment of Severe COVID-19: a Randomized Clinical Trial (COLCHIVID). J Gen Intern Med. 2022 Jan;37(1):4-14. doi: 10.1007/s11606-021-07203-8. Epub 2021 Nov 9.

    PubMed 34755269

  • Pan Y, Fan F, Jiang J, Zhang Y. Clinical outcomes of anti-inflammatory therapies inhibiting the NLRP3/IL-1beta/IL-6/CRP pathway in coronary artery disease patients: a systemic review and meta-analysis of 37,056 individuals from 32 randomized trials. Inflamm Res. 2025 Jun 30;74(1):99. doi: 10.1007/s00011-025-02058-9.

    PubMed 40583093

  • Yang S, Huang H, Jiang K, Peng Y, Liang Z, Gong X, Li L, Li Y, Zhang B, Chen Y, Yang X. Colchicine inhibits vascular calcification by suppressing inflammasome activation through the enhancement of the Sirt2-PP2Ac signaling pathway. J Biol Chem. 2025 Jul;301(7):110381. doi: 10.1016/j.jbc.2025.110381. Epub 2025 Jun 14.

    PubMed 40523615

  • Pan Z, Cheng J, Yang W, Chen L, Wang J. Effect of colchicine on inflammatory markers in patients with coronary artery disease: A meta-analysis of clinical trials. Eur J Pharmacol. 2022 Jul 15;927:175068. doi: 10.1016/j.ejphar.2022.175068. Epub 2022 May 27.

    PubMed 35644423

  • Kiraz S, Ertenli I, Arici M, Calguneri M, Haznedaroglu I, Celik I, Pay S, Kirazli S. Effects of colchicine on inflammatory cytokines and selectins in familial Mediterranean fever. Clin Exp Rheumatol. 1998 Nov-Dec;16(6):721-4.

    PubMed 9844766

  • Shi M, Zhang X, Li L, Wang Y, Zhao Q, Zhen Y, Huang Y, Liu C. Colchicine reduces inflammatory cytokines and improves symptoms in HFpEF: an observational pilot study. Front Med (Lausanne). 2026 Jan 16;12:1702293. doi: 10.3389/fmed.2025.1702293. eCollection 2025.

    PubMed 41625765

  • Astiawati T, Rohman MS, Wihastuti T, Sujuti H, Endharti A, Sargowo D, Oceandy D, Lestari B, Triastuti E, Nugraha RA. The Emerging Role of Colchicine to Inhibit NOD-like Receptor Family, Pyrin Domain Containing 3 Inflammasome and Interleukin-1beta Expression in In Vitro Models. Biomolecules. 2025 Mar 3;15(3):367. doi: 10.3390/biom15030367.

    PubMed 40149903

  • Liu Q, Yu L, Yin X, Ye J, Li S. Correlation Between Soluble Klotho and Vascular Calcification in Chronic Kidney Disease: A Meta-Analysis and Systematic Review. Front Physiol. 2021 Aug 13;12:711904. doi: 10.3389/fphys.2021.711904. eCollection 2021.

    PubMed 34483963

  • Ayu NP, Kandarini Y, Widiana R, Mahadita GW. Fetuin-A as a risk factor for arteriovenous fistula failure in chronic kidney disease patients with hemodialysis through vascular calcification mechanism: Systematic review and meta-analysis. J Vasc Access. 2026 Jul;27(4):1450-1462. doi: 10.1177/11297298251407274. Epub 2026 Jan 16.

    PubMed 41542792

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low-dose Colchicine at 0.5mg daily in people with Chronic Kidney Disease Mineral and Bone Disorder and Cognitive Function, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexandra R Hartman (614-420-1186, RESOLVE-CKD@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Coronary Artery Calcification Agatston Scores (time frame: Baseline, 12 months, 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07654231, which also lists 41 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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