| Registry | NCT07762807, acronym CAD |
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| Status | Recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, other |
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| Enrollment | 100 (Estimated) |
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| Sponsor | King's College London (Other); collaborators: Guy's and St Thomas' NHS Foundation Trust |
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| Conditions | Haemodialysis Patients, Colchicine, Feasibility Study |
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| Interventions | Colchicine 0.5 mg (Drug) |
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| Dates | start 2025-04-10, primary completion 2027-11-01 (estimated), completion 2027-11-01 (estimated), first posted 2026-08-13, last updated 2026-08-13 |
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| Locations | 1 site in United Kingdom |
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-Summary
Colchicine is an inexpensive drug that has been available for decades. Trials, which excluded patients with kidney disease, showed that colchicine decreased the number of heart attacks and strokes. The investigators cannot be sure if these results will apply to dialysis patients and a clinical trial exploring the effect of colchicine on heart attacks and strokes specifically in dialysis patients is needed. Colchicine may also be beneficial for dialysis patients as it may help arteriovenous fistulas to last longer. An arteriovenous fistula is a connection made between an artery and a vein in the arm, allowing for access to a person's bloodstream as part of dialysis. Sometimes, these connections can get too narrow in some parts, stopping them from working properly. These narrowings can be treated with a balloon inserted into the vein with the help of an x-ray. Balloons coated with a drug called paclitaxel, which works like colchicine, can be helpful, so the investigators think colchicine may help too.
At present, colchicine is often avoided in patients receiving dialysis. Patients on haemodialysis take a number of medications already and have significant comorbidity. Therefore, it is possible that a higher proportion would have difficulty tolerating colchicine. These concerns mean that a large trial assessing the potential benefits of colchicine in this population cannot begin without further data on feasibility.
This feasibility study will establish whether low dose colchicine is tolerated and acceptable to dialysis patients and will help the investigators to plan recruitment to future clinical trials. The investigators will give colchicine to 100 dialysis patients. The investigators will monitor the participants for side effects and see how many continue to take it for the planned period of 3 months. If feasibility is confirmed, there are then strong rationales for large clinical trials exploring the effect of colchicine on both mortality and vascular access outcomes in dialysis patients.
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+Detailed description
This study will include patients on haemodialysis from a single large renal centre.
All participants will receive a low dose of colchicine once a day for 3 months and 2 weeks.
There will be no control group in order to maximize the data on tolerability, in relation to the number of participants recruited. The lack of a comparator arm will not affect this key outcome measure.
Blood will be taken to assess blood count, liver function and creatinine kinase at the start of the trial, at two weeks, and then at monthly intervals. These blood tests will be taken on haemodialysis with no additional venepuncture or visits required.
Patients will be interviewed by telephone on day 2 and then at the time of the monthly blood tests, to ask about any side effects.
At baseline and at 3 months and 2 weeks, patients will be asked to complete a survey about their quality of life. No extra hospital visits will be needed, and blood will be taken on dialysis at the same time as the usual monthly bloods.
Our hypothesis is that colchicine will be well tolerated in this patient group.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Colchicine | Experimental | Drug: Colchicine 0.5 mg | |
- Colchicine 0.5 mg (Drug): Colchicine 0.5mg once a day orally for 3 months and 2 weeks
+Outcome measures
Primary outcomes
- Feasibility to progress to a full-scale trial [From enrolment to the end of treatment at 3 months and 2 weeks]: Patients approached, screened, and included in the study (consent rate).
- Feasibility to Progress to a Full-Scale Trial [From enrolment to the end of treatment at 3 months and 2 weeks]: Patients who continue colchicine until the end of the study.
Secondary outcomes
- Feasibility of data collection [From enrolment to the end of treatment at 3 months and 2 weeks]: To demonstrate feasibility of data collection, summary statistics will be presented on the following and may include estimation of confidence intervals: EQ-5D-5L measures.
- Feasibility of data collection [From enrolment to the end of treatment at 3 months and 2 weeks]: To demonstrate feasibility of data collection, summary statistics will be presented on the following and may include estimation of confidence intervals: VASQoL measures.
- Feasibility of data collection [From enrolment to the end of treatment at 3 months and 2 weeks]: To demonstrate feasibility of data collection, summary statistics will be presented on the following and may include estimation of confidence intervals: Vascular access events and interventions (radiological or surgical).
- Feasibility of data collection [From enrolment to the end of treatment at 3 months and 2 weeks]: To demonstrate feasibility of data collection, summary statistics will be presented on the following and may include estimation of confidence intervals: Adverse events.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
1. Anyone who is undergoing haemodialysis.
2. Aged 18 or over
3. Able to give informed consent
Exclusion Criteria:
1. Already taking colchicine for a clinical indication.
2. Taking a drug known to increase colchicine levels.
3. Has a previously documented intolerance of or allergy to colchicine
4. Has a history of chronic liver disease, or abnormal liver function (i.e. ALT > 1.5 x upper limit of normal). Patients with a history of hepatitis are eligible provided these limits are not exceeded.
+Locations (1)
| Facility | City | Country | Status |
|---|
| Guy's and St Thomas' NHS Trust | London | United Kingdom | Recruiting |
+Publications
- Richarz S, Greenwood S, Kingsmore DB, Thomson PC, Dunlop M, Bouamrane MM, Meiklem R, Stevenson K. Validation of a vascular access specific quality of life measure (VASQoL). J Vasc Access. 2023 Jul;24(4):702-714. doi: 10.1177/11297298211046746. Epub 2021 Oct 5. PMID 34608832
- Wason S, Mount D, Faulkner R. Single-dose, open-label study of the differences in pharmacokinetics of colchicine in subjects with renal impairment, including end-stage renal disease. Clin Drug Investig. 2014 Dec;34(12):845-55. doi: 10.1007/s40261-014-0238-6. PMID 25385362
- Solak Y, Atalay H, Biyik Z, Alibasic H, Gaipov A, Guney F, Kucuk A, Tonbul HZ, Yeksan M, Turk S. Colchicine toxicity in end-stage renal disease patients: a case-control study. Am J Ther. 2014 Nov-Dec;21(6):e189-95. doi: 10.1097/MJT.0b013e31825a364a. PMID 22874645
- Stewart S, Yang KCK, Atkins K, Dalbeth N, Robinson PC. Adverse events during oral colchicine use: a systematic review and meta-analysis of randomised controlled trials. Arthritis Res Ther. 2020 Feb 13;22(1):28. doi: 10.1186/s13075-020-2120-7. PMID 32054504
- Deftereos SG, Beerkens FJ, Shah B, Giannopoulos G, Vrachatis DA, Giotaki SG, Siasos G, Nicolas J, Arnott C, Patel S, Parsons M, Tardif JC, Kovacic JC, Dangas GD. Colchicine in Cardiovascular Disease: In-Depth Review. Circulation. 2022 Jan 4;145(1):61-78. doi: 10.1161/CIRCULATIONAHA.121.056171. Epub 2021 Dec 29. PMID 34965168
- Trerotola SO, Lawson J, Roy-Chaudhury P, Saad TF; Lutonix AV Clinical Trial Investigators. Drug Coated Balloon Angioplasty in Failing AV Fistulas: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2018 Aug 7;13(8):1215-1224. doi: 10.2215/CJN.14231217. Epub 2018 Jul 24. PMID 30042225
- Karunanithy N, Robinson EJ, Ahmad F, Burton JO, Calder F, Coles S, Das N, Dorling A, Forman C, Jaffer O, Lawman S, Lakshminarayan R, Lewlellyn R, Peacock JL, Ramnarine R, Mesa IR, Shaikh S, Simpson J, Steiner K, Suckling R, Szabo L, Turner D, Wadoodi A, Wang Y, Weir G, Wilkins CJ, Gardner LM, Robson MG. A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas. Kidney Int. 2021 Aug;100(2):447-456. doi: 10.1016/j.kint.2021.02.040. Epub 2021 Mar 27. PMID 33781793
- Lookstein RA, Haruguchi H, Ouriel K, Weinberg I, Lei L, Cihlar S, Holden A; IN.PACT AV Access Investigators. Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas. N Engl J Med. 2020 Aug 20;383(8):733-742. doi: 10.1056/NEJMoa1914617. PMID 32813949
- Bountouris I, Kristmundsson T, Dias N, Zdanowski Z, Malina M. Is Repeat PTA of a Failing Hemodialysis Fistula Durable? Int J Vasc Med. 2014;2014:369687. doi: 10.1155/2014/369687. Epub 2014 Jan 22. PMID 24587906
- Turmel-Rodrigues L, Pengloan J, Baudin S, Testou D, Abaza M, Dahdah G, Mouton A, Blanchard D. Treatment of stenosis and thrombosis in haemodialysis fistulas and grafts by interventional radiology. Nephrol Dial Transplant. 2000 Dec;15(12):2029-36. doi: 10.1093/ndt/15.12.2029. PMID 11096150
- Aktas A, Bozkurt A, Aktas B, Kirbas I. Percutaneous transluminal balloon angioplasty in stenosis of native hemodialysis arteriovenous fistulas: technical success and analysis of factors affecting postprocedural fistula patency. Diagn Interv Radiol. 2015 Mar-Apr;21(2):160-6. doi: 10.5152/dir.2014.14348. PMID 25698092
- Heye S, Maleux G, Vaninbroukx J, Claes K, Kuypers D, Oyen R. Factors influencing technical success and outcome of percutaneous balloon angioplasty in de novo native hemodialysis arteriovenous fistulas. Eur J Radiol. 2012 Sep;81(9):2298-303. doi: 10.1016/j.ejrad.2011.09.004. Epub 2011 Sep 28. PMID 21955605
- Manninen HI, Kaukanen ET, Ikaheimo R, Karhapaa P, Lahtinen T, Matsi P, Lampainen E. Brachial arterial access: endovascular treatment of failing Brescia-Cimino hemodialysis fistulas--initial success and long-term results. Radiology. 2001 Mar;218(3):711-8. doi: 10.1148/radiology.218.3.r01mr38711. PMID 11230644
- Rajan DK, Bunston S, Misra S, Pinto R, Lok CE. Dysfunctional autogenous hemodialysis fistulas: outcomes after angioplasty--are there clinical predictors of patency? Radiology. 2004 Aug;232(2):508-15. doi: 10.1148/radiol.2322030714. PMID 15286321
- Manou-Stathopoulou S, Robinson EJ, Harvey JJ, Karunanithy N, Calder F, Robson MG. Factors associated with outcome after successful radiological intervention in arteriovenous fistulas: A retrospective cohort. J Vasc Access. 2019 Nov;20(6):716-724. doi: 10.1177/1129729819845991. Epub 2019 May 14. PMID 31084389
- Roy-Chaudhury P, Arend L, Zhang J, Krishnamoorthy M, Wang Y, Banerjee R, Samaha A, Munda R. Neointimal hyperplasia in early arteriovenous fistula failure. Am J Kidney Dis. 2007 Nov;50(5):782-90. doi: 10.1053/j.ajkd.2007.07.019. PMID 17954291
- Cozzolino M, Mangano M, Stucchi A, Ciceri P, Conte F, Galassi A. Cardiovascular disease in dialysis patients. Nephrol Dial Transplant. 2018 Oct 1;33(suppl_3):iii28-iii34. doi: 10.1093/ndt/gfy174. PMID 30281132
- Tardif JC, Kouz S, Waters DD, Bertrand OF, Diaz R, Maggioni AP, Pinto FJ, Ibrahim R, Gamra H, Kiwan GS, Berry C, Lopez-Sendon J, Ostadal P, Koenig W, Angoulvant D, Gregoire JC, Lavoie MA, Dube MP, Rhainds D, Provencher M, Blondeau L, Orfanos A, L'Allier PL, Guertin MC, Roubille F. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction. N Engl J Med. 2019 Dec 26;381(26):2497-2505. doi: 10.1056/NEJMoa1912388. Epub 2019 Nov 16. PMID 31733140
- 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. PMID 32865380
+Investigators