Colchicine And Dialysis Patients; a Feasibility Study

NCT07762807 | Recruiting DMC

• 1 other identifier: 335421
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Haemodialysis Patients; Colchicine; Feasibility Study

Keywords

Colchicine; Haemodialysis Patients; Feasibility Study

Outcome Measures

Primary Outcomes (2)

• Feasibility to progress to a full-scale trial

  Patients approached, screened, and included in the study (consent rate).

  From enrolment to the end of treatment at 3 months and 2 weeks

• Feasibility to Progress to a Full-Scale Trial

  Patients who continue colchicine until the end of the study.

  From enrolment to the end of treatment at 3 months and 2 weeks

Secondary Outcomes (4)

• Feasibility of data collection

  From enrolment to the end of treatment at 3 months and 2 weeks

• Feasibility of data collection

  From enrolment to the end of treatment at 3 months and 2 weeks

• Feasibility of data collection

  From enrolment to the end of treatment at 3 months and 2 weeks

• Feasibility of data collection

  From enrolment to the end of treatment at 3 months and 2 weeks

Study Arms (1)

Colchicine

EXPERIMENTAL

Drug: Colchicine 0.5 mg

Interventions

Colchicine 0.5 mg DRUG

Colchicine 0.5mg once a day orally for 3 months and 2 weeks

Colchicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anyone who is undergoing haemodialysis.
• Aged 18 or over
• Able to give informed consent

You may not qualify if:

• Already taking colchicine for a clinical indication.
• Taking a drug known to increase colchicine levels.
• Has a previously documented intolerance of or allergy to colchicine
• 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.

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Trust

London, United Kingdom

RECRUITING

Related Publications (19)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Dr Michael Robson

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Dorothy Wong

CONTACT

+44 (0)20 7188 3563; dorothy.wong@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, single-centre, single-armed feasibility study

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 13, 2026
• Study Start: April 10, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Research data and documentation will be stored for at least 15 years after the study has ended.
• Access Criteria: Request to access the data will be submitted to the CI for review before access is granted. External institutions, including outside the UK, will be able to apply for access to the anonymised data, and if they are granted access a data sharing agreement will be put in place.

Locations

GB (1)