Chronic Kidney Disease Mineral and Bone DisorderPhase 2RESOLVE-CKDNCT07654231
Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD
A Phase 2 study testing Low-dose Colchicine at 0.5mg daily in people with Chronic Kidney Disease Mineral and Bone Disorder and Hypertension, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Chronic Kidney Disease Mineral and Bone Disorder, Hypertension, Diabetes
- 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
- 1 Jul 2026to 31 Dec 2027
- 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 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Disease Mineral and Bone Disorder, Hypertension, Diabetes, Dyslipidemia, Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (Stage 3)
- Being tested
- Low-dose Colchicine at 0.5mg daily, Usual Care
- Keywords
- Chronic Kidney Disease, CVD, vascular calcification, Colchicine
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder, Hypertension, Diabetes Mellitus, Dyslipidemias, Atherosclerosis, Renal Insufficiency, Chronic, Vascular Calcification
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 group | Role | What they receive |
|---|---|---|
| Low-Dose Colchicine (LoDoCo) | Active comparator | Participants will receive low-dose Colchicine (LoDoCo) in addition to usual care. Receives: Drug: Low-dose Colchicine at 0.5mg daily; Other: Usual Care |
| Usual Care | Active comparator | Participants 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.
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. 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
Secondary outcomes (20)
Change in Coronary Artery Calcification Volume Scores
Change in Coronary Artery Calcification volume (mm3) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
Measured: Baseline, 12 months
Change in Cardiac Artery Calcification Mass Scores
Change in Cardiac Artery Calcification Mass (mg) score will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
Measured: Baseline, 12 months
Change in Serum Klotho Levels
Circulating klotho levels (pg/mL) will be measured using standard clinical laboratory assays.
Measured: Baseline, 6 months, 12 months
Change in Fetuin A Levels
Circulating fetuin A levels (ng/mL) will be measured using standard clinical laboratory assays
Measured: Baseline, 6 months, 12 months
Change in Serum Phosphate levels
Circulating serum phosphate levels (mg/dL) will be measured using standard clinical laboratory assays.
Measured: Baseline, 6 months, 12 months
Change in Serum Calcium Levels
Circulating serum calcium levels (mg/dL) will be measured using standard clinical laboratory assays.
Measured: Baseline, 6 months, 12 months
Change in Parathyroid Hormone (PTH) levels
Circulating PTH levels (pg/mL) will be measured using standard clinical laboratory assays.
Measured: Baseline, 6 months, 12 months
Change in C-terminal Fibroblast Growth Factor 23 (FGF23) Levels
Circulating C-terminal FGF23 levels (RU/mL) will be measured using standard clinical laboratory assays.
Measured: Baseline, 6 months, 12 months
Change in Fibroblast Growth Factor 23 (FGF23) Levels
Circulating FGF23 levels (pg/mL) will be measured using standard clinical laboratory assays.
Measured: Baseline, 6 months, 12 months
Change in Bone-Specific Alkaline Phosphatase (BSAP) Levels
Circulating serum BSAP levels (ug/L) will be measured using standard clinical laboratory assays.
Measured: Baseline, 6 months, 12 months
Change in C-terminal Telopeptide of Type I Collagen (CTX)
Circulating CTX levels (ng/mL) will be measured using standard clinical laboratory assays.
Measured: Baseline, 6 months, 12 months
Change in Tartrate-Resistant Acid Phosphatase 5b (TRAP-5b) Levels
Circulating TRAP-5b levels (U/L) will be measured using standard clinical laboratory assays
Measured: Baseline, 6 months, 12 months
Change in Sclerostin Levels
Circulating sclerostin levels (pg/mL) will be measured using standard clinical laboratory assays.
Measured: Baseline, 6 months, 12 months
Change in Lumbar Spine Bone Mineral Density (BMD)
BMD at the lumbar spine (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
Measured: Baseline, 12 months
Change in Hip Bone Mineral Density (BMD)
BMD at the hip (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
Measured: Baseline, 12 months
Change in Radius Bone Mineral Density (BMD)
BMD at the radius (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard man
Measured: Baseline, 12 months
Change in Interleukin-6 (IL-6) Levels
Circulating IL-6 levels (pg/mL) will be measured using standard clinical laboratory assays.
Measured: Baseline, 6 months, 12 months
Change in Soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) Levels
Circulating sTNFR1 levels (pg/mL) will be measured using standard clinical laboratory assays.
Measured: Baseline, 6 months, 12 months
Change in Interleukin-17 (IL-17) Levels
Circulating IL-17 levels (pg/mL) will be measured using standard clinical laboratory assays.
Measured: Baseline, 6 months, 12 months
Change in Intact N-Terminal Propeptide of Type I Procollagen (P1NP) Levels
Circulating P1NP levels (pg/mL) will be measured using standard clinical laboratory assays.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Mineral and Bone DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Chen, University of Texas Southwestern Medical Center
- Investigators
- Jing Chen, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654231
- Sponsor's protocol ID
- STU20260896
- Other IDs
- 99077
- Acronym
- RESOLVE-CKD
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 22 Jun 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
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 41670023Nidorf 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 32865380Absalon-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 34755269Pan 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 40583093Yang 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 40523615Pan 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 35644423Kiraz 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 9844766Shi 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 41625765Astiawati 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 40149903Liu 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 34483963Ayu 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 41542792Henaut L, Massy ZA. New insights into the key role of interleukin 6 in vascular calcification of chronic kidney disease. Nephrol Dial Transplant. 2018 Apr 1;33(4):543-548. doi: 10.1093/ndt/gfx379. No abstract available.
PubMed 29420799Pang Q, Wang P, Pan Y, Dong X, Zhou T, Song X, Zhang A. Irisin protects against vascular calcification by activating autophagy and inhibiting NLRP3-mediated vascular smooth muscle cell pyroptosis in chronic kidney disease. Cell Death Dis. 2022 Mar 30;13(3):283. doi: 10.1038/s41419-022-04735-7.
PubMed 35354793Bundy JD, Chen J, Yang W, Budoff M, Go AS, Grunwald JE, Kallem RR, Post WS, Reilly MP, Ricardo AC, Rosas SE, Zhang X, He J; CRIC Study Investigators. Risk factors for progression of coronary artery calcification in patients with chronic kidney disease: The CRIC study. Atherosclerosis. 2018 Apr;271:53-60. doi: 10.1016/j.atherosclerosis.2018.02.009. Epub 2018 Feb 10.
PubMed 29459266Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C; FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009 Aug 20;361(8):756-65. doi: 10.1056/NEJMoa0809493. Epub 2009 Aug 11.
PubMed 19671655
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)
- ClinicalTrials.gov ID
- NCT07654231
- Acronym / sponsor ID
- RESOLVE-CKD / STU20260896
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Colchicine (LoDoCo) | Active comparator | Drug: Low-dose Colchicine at 0.5mg daily, Other: Usual CareParticipants will receive low-dose Colchicine (LoDoCo) in addition to usual care. |
| Usual Care | Active comparator | Other: Usual CareParticipants will receive usual care alone. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose Colchicine at 0.5mg dailyAlso: LoDoCoIntervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily. | Drug | Low-Dose Colchicine (LoDoCo) |
| Usual CareParticipants will receive usual care according to standard clinical practice and treating physician discretion. | Other | Low-Dose Colchicine (LoDoCo), Usual Care |
Primary outcome
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.
20 secondary outcomes
Change in Coronary Artery Calcification Volume Scores
Time frame: Baseline, 12 months
Change in Cardiac Artery Calcification Mass Scores
Time frame: Baseline, 12 months
Change in Serum Klotho Levels
Time frame: Baseline, 6 months, 12 months
Change in Fetuin A Levels
Time frame: Baseline, 6 months, 12 months
Change in Serum Phosphate levels
Time frame: Baseline, 6 months, 12 months
Change in Serum Calcium Levels
Time frame: Baseline, 6 months, 12 months
Change in Parathyroid Hormone (PTH) levels
Time frame: Baseline, 6 months, 12 months
Change in C-terminal Fibroblast Growth Factor 23 (FGF23) Levels
Time frame: Baseline, 6 months, 12 months
Change in Fibroblast Growth Factor 23 (FGF23) Levels
Time frame: Baseline, 6 months, 12 months
Change in Bone-Specific Alkaline Phosphatase (BSAP) Levels
Time frame: Baseline, 6 months, 12 months
Change in C-terminal Telopeptide of Type I Collagen (CTX)
Time frame: Baseline, 6 months, 12 months
Change in Tartrate-Resistant Acid Phosphatase 5b (TRAP-5b) Levels
Time frame: Baseline, 6 months, 12 months
Change in Sclerostin Levels
Time frame: Baseline, 6 months, 12 months
Change in Lumbar Spine Bone Mineral Density (BMD)
Time frame: Baseline, 12 months
Change in Hip Bone Mineral Density (BMD)
Time frame: Baseline, 12 months
Change in Radius Bone Mineral Density (BMD)
Time frame: Baseline, 12 months
Change in Interleukin-6 (IL-6) Levels
Time frame: Baseline, 6 months, 12 months
Change in Soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) Levels
Time frame: Baseline, 6 months, 12 months
Change in Interleukin-17 (IL-17) Levels
Time frame: Baseline, 6 months, 12 months
Change in Intact N-Terminal Propeptide of Type I Procollagen (P1NP) Levels
Time frame: Baseline, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 41670023Budoff 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.
- Background: PubMed 32865380Nidorf 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.
- Background: PubMed 34755269Absalon-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.
- Background: PubMed 40583093Pan 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.
- Background: PubMed 40523615Yang 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.
- Background: PubMed 35644423Pan 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.
- Background: PubMed 9844766Kiraz 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.
- Background: PubMed 41625765Shi 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.
- Background: PubMed 40149903Astiawati 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.
- Background: PubMed 34483963Liu 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.
- Background: PubMed 41542792Ayu 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.
- Background: PubMed 29420799Henaut L, Massy ZA. New insights into the key role of interleukin 6 in vascular calcification of chronic kidney disease. Nephrol Dial Transplant. 2018 Apr 1;33(4):543-548. doi: 10.1093/ndt/gfx379. No abstract available.
- Individual participant dataSharing planned: Yes. IRB approval is required before sharing IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Chen, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
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 Hypertension, 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 6 inclusion and 25 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 22 Jun 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). 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 37 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 22 Jun 2026.