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| ID | Type | Description | Link |
|---|---|---|---|
| 99077 | Other Identifier | UT Southwestern Medical Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Dose Colchicine (LoDoCo) | Active Comparator | Participants will receive low-dose Colchicine (LoDoCo) in addition to usual care. |
|
| Usual Care | Active Comparator | Participants will receive usual care alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose Colchicine at 0.5mg daily | Drug | Intervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 12 months |
| Change in Cardiac Artery Calcification Mass Scores |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: Change in Urine Albumin-to-Creatine Ratio (uACR) | 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) |
Inclusion Criteria:
Exclusion Criteria:
female or male
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra R Hartman | Contact | 614-420-1186 | RESOLVE-CKD@UTSouthwestern.edu | |
| Paola Lanza, MD | Contact | 469-852-9550 | paola.lanza@UTSouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jing Chen, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41670023 | Background | 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. | |
| 32865380 |
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IRB approval is required before sharing IPD.
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| Usual Care | Other | Participants will receive usual care according to standard clinical practice and treating physician discretion. |
|
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 | Circulating klotho levels (pg/mL) will be measured using standard clinical laboratory assays. | Baseline, 6 months, 12 months |
| Change in Fetuin A Levels | Circulating fetuin A levels (ng/mL) will be measured using standard clinical laboratory assays | Baseline, 6 months, 12 months |
| Change in Serum Phosphate levels | Circulating serum phosphate levels (mg/dL) will be measured using standard clinical laboratory assays. | Baseline, 6 months, 12 months |
| Change in Serum Calcium Levels | 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 | 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 | 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 | 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 | 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) | 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 | Circulating TRAP-5b levels (U/L) will be measured using standard clinical laboratory assays | Baseline, 6 months, 12 months |
| Change in Sclerostin Levels | 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) | 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) | 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) | 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 | 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 | 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 | 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 | Circulating P1NP levels (pg/mL) will be measured using standard clinical laboratory assays. | 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) | 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) | 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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| ID | Term |
|---|---|
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| D050171 | Dyslipidemias |
| D050197 | Atherosclerosis |
| D051436 | Renal Insufficiency, Chronic |
| D061205 | Vascular Calcification |
| ID | Term |
|---|---|
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D052439 | Lipid Metabolism Disorders |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D051437 | Renal Insufficiency |
| D002114 | Calcinosis |
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