Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD (RESOLVE-CKD)
17 juni 2026 uppdaterad av: Jing Chen, University of Texas Southwestern Medical Center
Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)
The overall objective of this pilot randomized clinical trial is to determine whether low-dose Colchicine (LoDoCo) improves vascular disease including vascular calcification, peripheral arterial disease (PAD), and chronic kidney disease-mineral and bone disorder (CKD-MBD) biomarkers in patients with chronic kidney disease (CKD) stage 3 over a 12-month intervention period, compared with usual care.
Successful completion of this study will generate critical preliminary data to support a larger clinical trial aimed at evaluating inflammation-targeted therapies to mitigate CKD-MBD, including vascular calcification and related PAD, as well as osteoporosis, ultimately reducing cardiovascular events and mortality in patients with CKD. Additionally, this work has the potential to redefine the diagnostic framework for CKD-MBD.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
60
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Paola Lanza, MD
- Telefonnummer: 469-852-9550
- E-post: paola.lanza@UTSouthwestern.edu
Studera Kontakt Backup
- Namn: Alexandra R Hartman
- Telefonnummer: 614-420-1186
- E-post: RESOLVE-CKD@UTSouthwestern.edu
Studieorter
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75390
- University of Texas Southwestern Medical Center
-
Huvudutredare:
- Jing Chen, MD
-
Kontakt:
- Paola Lanza, MD
- Telefonnummer: 469-852-9550
- E-post: paola.lanza@UTSouthwestern.edu
-
Kontakt:
- Alexandra R Hartman
- Telefonnummer: 214-645-8294
- E-post: alexandra.hartman@UTSouthwestern.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Men and women aged 18-<70 years of all race/ethnicity groups
- CKD stage 3 (estimated glomerular filtration rate (eGFR) >30 to 59 ml/min/1.73m2)
- Urine albumin-to-creatinine ratio (uACR) ≥ 200 mg/g
- Cardiac artery calcification (CAC) Agatston score ≥30
- Hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD) (coronary artery disease (CAD), ischemic stroke, and peripheral artery disease), defined by self-report, ICD-10 codes, or the use of medications for these conditions.
- Ability to provide informed consent.
Exclusion Criteria:
- Current Colchicine therapy
- Hepatic disease
- Any clinically active diagnosed infection requiring systemic antimicrobial therapy, positive microbiologic evidence of infection, or infection-related hospitalization within 30 days prior to study enrollment.
- Immunosuppression
- Current use of chemotherapy drugs or active cancer
- Pregnancy/breastfeeding
- Hospitalized within the past 6 months
- Allergic/intolerance to colchicine
- Use of P-glycoprotein (p-gp) inhibitor (such as Verapamil, Quinidine, Amiodarone, Ritonavir, Lopinavir/ritonavir, Saquinavir, Nelfinavir)
- Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (such as Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Clarithromycin, Erythromycin)
- Human immunodeficiency virus (HIV) infection
- Gout attack ≥ 1 time per year
- Severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men)
- eGFR <30 ml/min/1.73m2
- uACR <200 mg/g
- White blood cell count (WBC) <3.0 x109/L
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x Upper Limit of Normal (ULN)
- Total bilirubin >2 x ULN
- Glucose >300mg/dl
- Uses nicotine products or other recreational drugs
- Unable to read or speak English
- Participant in other conflict clinical trial,
- Unable to complete the study measurements
- Unable to undergo to computed tomography (CT) or dual-energy X-ray absorptiometry (DXA) scans
- Unsafe to participate in this study per investigator's judgement.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Low-Dose Colchicine (LoDoCo)
Participants will receive low-dose Colchicine (LoDoCo) in addition to usual care.
|
Intervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily.
Andra namn:
Participants will receive usual care according to standard clinical practice and treating physician discretion.
|
|
Aktiv komparator: Usual Care
Participants will receive usual care alone.
|
Participants will receive usual care according to standard clinical practice and treating physician discretion.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Coronary Artery Calcification Agatston Scores
Tidsram: Baseline, 12 months
|
Agatston scores (Agatston units) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
Coronary artery calcification will be quantified using the Coronary Artery Calcium (CAC) Agatston Score.
Scores range from 0 Agatston units (no detectable coronary calcification), 1-99 Agatston units (mild calcification), 100-399 Agatston units (moderate calcification), and ≥400 Agatston units (severe calcification, high atherosclerotic burden).
Higher scores indicate greater coronary artery calcification and are associated with worse outcomes.
|
Baseline, 12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Coronary Artery Calcification Volume Scores
Tidsram: Baseline, 12 months
|
Change in Coronary Artery Calcification volume (mm3) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
|
Baseline, 12 months
|
|
Change in Cardiac Artery Calcification Mass Scores
Tidsram: Baseline, 12 months
|
Change in Cardiac Artery Calcification Mass (mg) score will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
|
Baseline, 12 months
|
|
Change in Serum Klotho Levels
Tidsram: Baseline, 6 months, 12 months
|
Circulating klotho levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Fetuin A Levels
Tidsram: Baseline, 6 months, 12 months
|
Circulating fetuin A levels (ng/mL) will be measured using standard clinical laboratory assays
|
Baseline, 6 months, 12 months
|
|
Change in Serum Phosphate levels
Tidsram: Baseline, 6 months, 12 months
|
Circulating serum phosphate levels (mg/dL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Serum Calcium Levels
Tidsram: Baseline, 6 months, 12 months
|
Circulating serum calcium levels (mg/dL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Parathyroid Hormone (PTH) levels
Tidsram: Baseline, 6 months, 12 months
|
Circulating PTH levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in C-terminal Fibroblast Growth Factor 23 (FGF23) Levels
Tidsram: Baseline, 6 months, 12 months
|
Circulating C-terminal FGF23 levels (RU/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Fibroblast Growth Factor 23 (FGF23) Levels
Tidsram: Baseline, 6 months, 12 months
|
Circulating FGF23 levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Bone-Specific Alkaline Phosphatase (BSAP) Levels
Tidsram: Baseline, 6 months, 12 months
|
Circulating serum BSAP levels (ug/L) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in C-terminal Telopeptide of Type I Collagen (CTX)
Tidsram: Baseline, 6 months, 12 months
|
Circulating CTX levels (ng/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Tartrate-Resistant Acid Phosphatase 5b (TRAP-5b) Levels
Tidsram: Baseline, 6 months, 12 months
|
Circulating TRAP-5b levels (U/L) will be measured using standard clinical laboratory assays
|
Baseline, 6 months, 12 months
|
|
Change in Sclerostin Levels
Tidsram: Baseline, 6 months, 12 months
|
Circulating sclerostin levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Lumbar Spine Bone Mineral Density (BMD)
Tidsram: Baseline, 12 months
|
BMD at the lumbar spine (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
|
Baseline, 12 months
|
|
Change in Hip Bone Mineral Density (BMD)
Tidsram: Baseline, 12 months
|
BMD at the hip (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
|
Baseline, 12 months
|
|
Change in Radius Bone Mineral Density (BMD)
Tidsram: Baseline, 12 months
|
BMD at the radius (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard man
|
Baseline, 12 months
|
|
Change in Interleukin-6 (IL-6) Levels
Tidsram: Baseline, 6 months, 12 months
|
Circulating IL-6 levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) Levels
Tidsram: Baseline, 6 months, 12 months
|
Circulating sTNFR1 levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Interleukin-17 (IL-17) Levels
Tidsram: Baseline, 6 months, 12 months
|
Circulating IL-17 levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Intact N-Terminal Propeptide of Type I Procollagen (P1NP) Levels
Tidsram: Baseline, 6 months, 12 months
|
Circulating P1NP levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Exploratory: Change in Urine Albumin-to-Creatine Ratio (uACR)
Tidsram: Baseline, 6 months, 12 months
|
Circulating urinary albumin and creatine levels (mg/dL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Exploratory: Change in Estimated Glomerular Filtration Rate (eGFR)
Tidsram: 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)
Tidsram: Baseline, 6 months, 12 months
|
ABI will be measured using semi-automated validated device (simpleABI-600CL).
ABI values range from ≤0.90 (Peripheral artery disease), 0.91-0.99
(borderline), 1.00-1.40
(normal).
ABI values >1.40 indicate non-compressible arteries, suggestive of arterial stiffness or medial calcification.
Both ABI values ≤0.90 and >1.40 are associated with worse outcomes.
|
Baseline, 6 months, 12 months
|
|
Exploratory: Change in Toe-Brachial Index (TBI)
Tidsram: Baseline, 6 months, 12 months
|
TBI will be measured using semi-automated validated device (simpleABI-600CL).
TBI values range from ≥0.70 (normal), 0.64-0.69
(borderline), and <0.40-0.50
(severe distal arterial disease/critical ischemia range).
TBI values <0.70 is a commonly used threshold suggestive of peripheral artery disease.
Lower TBI values are associated with worse outcomes.
|
Baseline, 6 months, 12 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Jing Chen, MD, University of Texas
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
1 december 2027
Avslutad studie (Beräknad)
31 december 2027
Studieregistreringsdatum
Först inskickad
11 juni 2026
Först inskickad som uppfyllde QC-kriterierna
11 juni 2026
Första postat (Faktisk)
17 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Sjukdomar i det endokrina systemet
- Skelettsjukdomar
- Muskuloskeletala sjukdomar
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Patologiska processer
- Näringsstörningar
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Metaboliska sjukdomar
- Störningar i glukosmetabolism
- Njurinsufficiens
- Skelettsjukdomar, metaboliska
- Paratyreoidea sjukdomar
- Lipidmetabolismstörningar
- Arterioskleros
- Arteriella ocklusiva sjukdomar
- Avitaminos
- Bristsjukdomar
- Undernäring
- Engelska sjukan
- Kalciummetabolismstörningar
- D-vitaminbrist
- Kalcinos
- Hyperparatyreos, sekundär
- Hyperparatyreos
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Hypertoni
- Diabetes mellitus
- Njurinsufficiens, kronisk
- Dyslipidemier
- Åderförkalkning
- Vaskulär förkalkning
- Kronisk njursjukdom - mineral- och benstörning
- Heterocykliska föreningar
- Alkaloider
- Kolchicin
Andra studie-ID-nummer
- STU20260896
- 99077 (Annan identifierare: UT Southwestern Medical Center)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
IRB approval is required before sharing IPD.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Ja
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .