Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD)
2026년 6월 11일 업데이트: 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 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
We will conduct a randomized, open-label, outcome blinded mechanistic clinical trial in 60 adults with stage 3 CKD who have hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD).
We will evaluate whether LoDoCo improves CAC and MBD over 12 months in patients with CKD, eGFR ≥30 to 59 mL/min/1.73 m², and 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 CCT from baseline to 12 months, second outcomes include changes in the individual biomarkers of MBD and VC from baseline and 12 months. Exploratory outcomes include changes in uACR, eGFR, ABI, and 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.
연구 유형
중재적
등록 (추정된)
60
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Paola Lanza, MD
- 전화번호: 469-852-9550
- 이메일: paola.lanza@UTSouthwestern.edu
연구 연락처 백업
- 이름: Alexandra R Hartman
- 전화번호: 614-420-1186
- 이메일: RESOLVE-CKD@UTSouthwestern.edu
연구 장소
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Texas
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Dallas, Texas, 미국, 75390
- University of Texas Southwestern Medical Center
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수석 연구원:
- Jing Chen, MD
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연락하다:
- Paola Lanza, MD
- 전화번호: 469-852-9550
- 이메일: paola.lanza@UTSouthwestern.edu
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연락하다:
- Alexandra R Hartman
- 전화번호: 214-645-8294
- 이메일: alexandra.hartman@UTSouthwestern.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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.
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-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
- WBC <3.0 x109/L
- AST or 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 CT or DXA scans
- Unsafe to participate in this study per investigator's judgement.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Intervention Group
Participants will receive LoDoCo (colchicine 0.5mg) in addition to usual care.
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Intervention group will receive LoDoCo (colchicine 0.5mg), oral, once daily.
다른 이름들:
Participants will receive usual care alone according to standard clinical practice and treating physician discretion.
|
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활성 비교기: Control Group
Participants will receive usual care alone.
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Participants will receive usual care alone according to standard clinical practice and treating physician discretion.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Coronary Artery Calcification Agatston Scores
기간: Baseline, 12 months
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Agatston scores (Agatston units) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
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Baseline, 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Coronary Artery Calcification Volume Scores
기간: Baseline, 12 months
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Change in Coronary Artery Calcification volume (mm3) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
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Baseline, 12 months
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Change in Cardiac Artery Calcification Mass Scores
기간: Baseline, 12 months
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Change in Cardiac Artery Calcification Mass (mg) score will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
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Baseline, 12 months
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Change in Serum Klotho Levels
기간: Baseline, 6 months, 12 months
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Circulating klotho levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Fetuin A Levels
기간: Baseline, 6 months, 12 months
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Circulating fetuin A levels (ng/mL) will be measured using standard clinical laboratory assays
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Baseline, 6 months, 12 months
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Change in Serum Phosphate levels
기간: Baseline, 6 months, 12 months
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Circulating serum phosphate levels (mg/dL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Serum Calcium Levels
기간: Baseline, 6 months, 12 months
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Circulating serum calcium levels (mg/dL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Parathyroid Hormone (PTH) levels
기간: Baseline, 6 months, 12 months
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Circulating PTH levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in C-terminal Fibroblast Growth Factor 23 (FGF23) Levels
기간: Baseline, 6 months, 12 months
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Circulating C-terminal FGF23 levels (RU/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Fibroblast Growth Factor 23 (FGF23) Levels
기간: Baseline, 6 months, 12 months
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Circulating FGF23 levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Bone-Specific Alkaline Phosphatase (BSAP) Levels
기간: Baseline, 6 months, 12 months
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Circulating serum BSAP levels (ug/L) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in C-terminal Telopeptide of Type I Collagen (CTX)
기간: Baseline, 6 months, 12 months
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Circulating CTX levels (ng/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Tartrate-Resistant Acid Phosphatase 5b (TRAP-5b) Levels
기간: Baseline, 6 months, 12 months
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Circulating TRAP-5b levels (U/L) will be measured using standard clinical laboratory assays
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Baseline, 6 months, 12 months
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Change in Sclerostin Levels
기간: Baseline, 6 months, 12 months
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Circulating sclerostin levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Lumbar Spine Bone Mineral Density (BMD)
기간: Baseline, 12 months
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BMD at the lumbar spine (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
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Baseline, 12 months
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Change in Hip Bone Mineral Density (BMD)
기간: Baseline, 12 months
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BMD at the hip (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
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Baseline, 12 months
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Change in Radius Bone Mineral Density (BMD)
기간: Baseline, 12 months
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BMD at the radius (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard man
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Baseline, 12 months
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Change in Interleukin-6 (IL-6) Levels
기간: Baseline, 6 months, 12 months
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Circulating IL-6 levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) Levels
기간: Baseline, 6 months, 12 months
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Circulating sTNFR1 levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Interleukin-17 (IL-17) Levels
기간: Baseline, 6 months, 12 months
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Circulating IL-17 levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Change in Intact N-Terminal Propeptide of Type I Procollagen (P1NP) Levels
기간: Baseline, 6 months, 12 months
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Circulating P1NP levels (pg/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Exploratory: Change in Urine Albumin-to-Creatine Ratio (uACR)
기간: Baseline, 6 months, 12 months
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Circulating urinary albumin and creatine levels (mg/dL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
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Exploratory: Change in Estimated Glomerular Filtration Rate (eGFR)
기간: Baseline, 6 months, 12 months
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eGFR values (mL/min/1.73m2)
will be calculated using the NKF-ASN CKD-Epi refit formula.
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Baseline, 6 months, 12 months
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Exploratory: Change in Ankle-Brachial Index (ABI)
기간: Baseline, 6 months, 12 months
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ABI will be measured using semi-automated validated device (simpleABI-600CL).
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Baseline, 6 months, 12 months
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Exploratory: Change in Toe-Brachial Index (TBI)
기간: Baseline, 6 months, 12 months
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TBI will be measured using semi-automated validated device (simpleABI-600CL).
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Baseline, 6 months, 12 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Jing Chen, MD, University of Texas
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Isakova T, Xie H, Yang W, Xie D, Anderson AH, Scialla J, Wahl P, Gutierrez OM, Steigerwalt S, He J, Schwartz S, Lo J, Ojo A, Sondheimer J, Hsu CY, Lash J, Leonard M, Kusek JW, Feldman HI, Wolf M; Chronic Renal Insufficiency Cohort (CRIC) Study Group. Fibroblast growth factor 23 and risks of mortality and end-stage renal disease in patients with chronic kidney disease. JAMA. 2011 Jun 15;305(23):2432-9. doi: 10.1001/jama.2011.826.
- Kestenbaum B, Sampson JN, Rudser KD, Patterson DJ, Seliger SL, Young B, Sherrard DJ, Andress DL. Serum phosphate levels and mortality risk among people with chronic kidney disease. J Am Soc Nephrol. 2005 Feb;16(2):520-8. doi: 10.1681/ASN.2004070602. Epub 2004 Dec 22.
- 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.
- 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.
- Vilaca T, Salam S, Schini M, Harnan S, Sutton A, Poku E, Allen IE, Cummings SR, Eastell R. Risks of Hip and Nonvertebral Fractures in Patients With CKD G3a-G5D: A Systematic Review and Meta-analysis. Am J Kidney Dis. 2020 Oct;76(4):521-532. doi: 10.1053/j.ajkd.2020.02.450. Epub 2020 Jul 9.
- Gupta J, Mitra N, Kanetsky PA, Devaney J, Wing MR, Reilly M, Shah VO, Balakrishnan VS, Guzman NJ, Girndt M, Periera BG, Feldman HI, Kusek JW, Joffe MM, Raj DS; CRIC Study Investigators. Association between albuminuria, kidney function, and inflammatory biomarker profile in CKD in CRIC. Clin J Am Soc Nephrol. 2012 Dec;7(12):1938-46. doi: 10.2215/CJN.03500412. Epub 2012 Sep 27.
- Amdur RL, Feldman HI, Gupta J, Yang W, Kanetsky P, Shlipak M, Rahman M, Lash JP, Townsend RR, Ojo A, Roy-Chaudhury A, Go AS, Joffe M, He J, Balakrishnan VS, Kimmel PL, Kusek JW, Raj DS; CRIC Study Investigators. Inflammation and Progression of CKD: The CRIC Study. Clin J Am Soc Nephrol. 2016 Sep 7;11(9):1546-1556. doi: 10.2215/CJN.13121215. Epub 2016 Jun 23.
- Chen J, Budoff MJ, Reilly MP, Yang W, Rosas SE, Rahman M, Zhang X, Roy JA, Lustigova E, Nessel L, Ford V, Raj D, Porter AC, Soliman EZ, Wright JT Jr, Wolf M, He J; CRIC Investigators. Coronary Artery Calcification and Risk of Cardiovascular Disease and Death Among Patients With Chronic Kidney Disease. JAMA Cardiol. 2017 Jun 1;2(6):635-643. doi: 10.1001/jamacardio.2017.0363.
- Cummings 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 Jan 16:11297298251407274. doi: 10.1177/11297298251407274. Online ahead of print.
- Henaut 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.
- Pang 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.
- Bundy 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.
- Nitta K, Akiba T, Suzuki K, Uchida K, Watanabe R, Majima K, Aoki T, Nihei H. Effects of cyclic intermittent etidronate therapy on coronary artery calcification in patients receiving long-term hemodialysis. Am J Kidney Dis. 2004 Oct;44(4):680-8.
- Neven EG, De Broe ME, D'Haese PC. Prevention of vascular calcification with bisphosphonates without affecting bone mineralization: a new challenge? Kidney Int. 2009 Mar;75(6):580-2. doi: 10.1038/ki.2008.663.
- Price PA, Faus SA, Williamson MK. Bisphosphonates alendronate and ibandronate inhibit artery calcification at doses comparable to those that inhibit bone resorption. Arterioscler Thromb Vasc Biol. 2001 May;21(5):817-24. doi: 10.1161/01.atv.21.5.817.
- Imanishi Y, Furukubo T, Shoji S. Clinical approaches to osteoporosis in patients with chronic kidney disease: A comprehensive review. Endocr J. 2025 Aug 1;72(8):847-862. doi: 10.1507/endocrj.EJ24-0271. Epub 2025 Apr 23.
- Xu B, Ma R, Wu Y, Liu C, Song X. Immune mechanisms in chronic kidney disease-mineral and bone disorder: current insights and therapeutic implications. Front Med (Lausanne). 2025 Oct 9;12:1678640. doi: 10.3389/fmed.2025.1678640. eCollection 2025.
- Zhao Y, Li H, Guo Y. Interleukin family in vascular calcification: molecular mechanisms and therapeutic perspectives. Front Cardiovasc Med. 2025 Sep 1;12:1619018. doi: 10.3389/fcvm.2025.1619018. eCollection 2025.
- Mazzaferro S, De Martini N, Rotondi S, Tartaglione L, Urena-Torres P, Bover J, Pasquali M; ERA-EDTA Working Group on CKD-MBD. Bone, inflammation and chronic kidney disease. Clin Chim Acta. 2020 Jul;506:236-240. doi: 10.1016/j.cca.2020.03.040. Epub 2020 Apr 8.
- Mazzaferro S, Bagordo D, De Martini N, Pasquali M, Rotondi S, Tartaglione L, Stenvinkel P; ERA-EDTA CKD-MBD working group. Inflammation, Oxidative Stress, and Bone in Chronic Kidney Disease in the Osteoimmunology Era. Calcif Tissue Int. 2021 Apr;108(4):452-460. doi: 10.1007/s00223-020-00794-0. Epub 2021 Jan 2.
- Lee BT, Ahmed FA, Hamm LL, Teran FJ, Chen CS, Liu Y, Shah K, Rifai N, Batuman V, Simon EE, He J, Chen J. Association of C-reactive protein, tumor necrosis factor-alpha, and interleukin-6 with chronic kidney disease. BMC Nephrol. 2015 May 30;16:77. doi: 10.1186/s12882-015-0068-7.
- She C, Liu H. Construction and validation of a predictive model for the risk of osteoporosis in patients with chronic kidney disease based on NHANES data. PLoS One. 2025 Feb 6;20(2):e0316494. doi: 10.1371/journal.pone.0316494. eCollection 2025.
- Magagnoli L, Cozzolino M, Caskey FJ, Evans M, Torino C, Porto G, Szymczak M, Krajewska M, Drechsler C, Stenvinkel P, Pippias M, Dekker FW, de Rooij ENM, Wanner C, Chesnaye NC, Jager KJ; EQUAL study investigators. Association between CKD-MBD and mortality in older patients with advanced CKD-results from the EQUAL study. Nephrol Dial Transplant. 2023 Oct 31;38(11):2562-2575. doi: 10.1093/ndt/gfad100.
- Geng S, Kuang Z, Peissig PL, Page D, Maursetter L, Hansen KE. Parathyroid hormone independently predicts fracture, vascular events, and death in patients with stage 3 and 4 chronic kidney disease. Osteoporos Int. 2019 Oct;30(10):2019-2025. doi: 10.1007/s00198-019-05033-3. Epub 2019 May 31.
- Isakova T, Cai X, Lee J, Xie D, Wang X, Mehta R, Allen NB, Scialla JJ, Pencina MJ, Anderson AH, Talierco J, Chen J, Fischer MJ, Steigerwalt SP, Leonard MB, Hsu CY, de Boer IH, Kusek JW, Feldman HI, Wolf M; Chronic Renal Insufficiency Cohort (CRIC) Study Investigators. Longitudinal FGF23 Trajectories and Mortality in Patients with CKD. J Am Soc Nephrol. 2018 Feb;29(2):579-590. doi: 10.1681/ASN.2017070772. Epub 2017 Nov 22.
- Wang XR, Zhang JJ, Xu XX, Wu YG. Prevalence of coronary artery calcification and its association with mortality, cardiovascular events in patients with chronic kidney disease: a systematic review and meta-analysis. Ren Fail. 2019 Nov;41(1):244-256. doi: 10.1080/0886022X.2019.1595646.
- Yamada S, Nakano T. Role of Chronic Kidney Disease (CKD)-Mineral and Bone Disorder (MBD) in the Pathogenesis of Cardiovascular Disease in CKD. J Atheroscler Thromb. 2023 Aug 1;30(8):835-850. doi: 10.5551/jat.RV22006. Epub 2023 May 30.
- Tian L, Jaeger BC, Scialla JJ, Budoff MJ, Mehta RC, Jaar BG, Saab G, Dobre MA, Reilly MP, Rader DJ, Townsend RR, Lash JP, Greenland P, Isakova T, Bundy JD; CRIC Study Investigators. Progression of Coronary Artery Calcification and Risk of Clinical Events in CKD: The Chronic Renal Insufficiency Cohort Study. Am J Kidney Dis. 2025 Jan;85(1):67-77.e1. doi: 10.1053/j.ajkd.2024.06.018. Epub 2024 Aug 16.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2027년 12월 1일
연구 완료 (추정된)
2027년 12월 31일
연구 등록 날짜
최초 제출
2026년 6월 11일
QC 기준을 충족하는 최초 제출
2026년 6월 11일
처음 게시됨 (실제)
2026년 6월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 11일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 비뇨생식기 질환
- 내분비계 질환
- 뼈 질환
- 근골격계 질환
- 혈관 질환
- 심혈관 질환
- 병리학적 과정
- 영양 장애
- 남성 비뇨 생식기 질환
- 신장 질환
- 비뇨기과 질환
- 여성 비뇨 생식기 질환
- 여성 비뇨 생식기 질환 및 임신 합병증
- 만성 질환
- 질병 속성
- 대사 질환
- 포도당 대사 장애
- 신부전
- 뼈 질환, 대사
- 부갑상선 질환
- 지질 대사 장애
- 동맥 경화증
- 동맥 폐색 질환
- 비타민제
- 결핍증
- 영양 실조
- 구루병
- 칼슘 대사 장애
- 비타민 D 결핍
- 석회화
- 부갑상선기능항진증, 속발성
- 부갑상선기능항진증
- 병리학적 상태, 징후 및 증상
- 영양 및 대사 질환
- 고혈압
- 진성 당뇨병
- 신부전, 만성
- 이상지질혈증
- 죽상동맥경화증
- 혈관석회화
- 만성 신장 질환-미네랄 및 뼈 장애
- 이종 사이 클릭 화합물
- 알칼로이드
- 콜히친
기타 연구 ID 번호
- STU20260896
- 99077 (기타 식별자: UT Southwestern Medical Center)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
IRB approval is required before sharing IPD.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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