Haemodialysis PatientsCADNCT07762807
Colchicine And Dialysis Patients; a Feasibility Study
A study testing Colchicine 0.5 mg in people with Haemodialysis Patients and Colchicine, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemodialysis Patients, Colchicine, Feasibility Study
- What is being tested?
- Colchicine 0.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Apr 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anyone who is undergoing haemodialysis.
- Aged 18 or over
- Able to give informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Trust
London
Dr Dorothy Wong, +44 (0)20 7188 3563, dorothy.wong@kcl.ac.uk
Dr Dorothy Wong
About this study
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.
Read the 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.
- Conditions
- Haemodialysis Patients, Colchicine, Feasibility Study
- Being tested
- Colchicine 0.5 mg
- Keywords
- Colchicine, Haemodialysis Patients, Feasibility Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 mgDrug
Colchicine 0.5mg once a day orally for 3 months and 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | Not described Receives: Drug: Colchicine 0.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility to progress to a full-scale trial
Patients approached, screened, and included in the study (consent rate).
Measured: 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.
Measured: From enrolment to the end of treatment at 3 months and 2 weeks
Secondary outcomes (4)
Feasibility of data collection
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.
Measured: From enrolment to the end of treatment at 3 months and 2 weeks
Feasibility of data collection
To demonstrate feasibility of data collection, summary statistics will be presented on the following and may include estimation of confidence intervals: VASQoL measures.
Measured: From enrolment to the end of treatment at 3 months and 2 weeks
Feasibility of data collection
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).
Measured: From enrolment to the end of treatment at 3 months and 2 weeks
Feasibility of data collection
To demonstrate feasibility of data collection, summary statistics will be presented on the following and may include estimation of confidence intervals: Adverse events.
Measured: From enrolment to the end of treatment at 3 months and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start10 Apr 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Haemodialysis PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, single-centre, single-armed feasibility study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Dr Michael Robson, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762807
- Sponsor's protocol ID
- 335421
- Other IDs
- 335421
- Acronym
- CAD
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data and documentation generated from the study
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.
PubMed 34608832Wason 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.
PubMed 25385362Solak 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.
PubMed 22874645Stewart 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.
PubMed 32054504Deftereos 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.
PubMed 34965168Trerotola 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.
PubMed 30042225Karunanithy 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.
PubMed 33781793Lookstein 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.
PubMed 32813949Bountouris 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.
PubMed 24587906Turmel-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.
PubMed 11096150Aktas 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.
PubMed 25698092Heye 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.
PubMed 21955605Manninen 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.
PubMed 11230644Rajan 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.
PubMed 15286321Manou-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.
PubMed 31084389
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine And Dialysis Patients; a Feasibility Study
- ClinicalTrials.gov ID
- NCT07762807
- Acronym / sponsor ID
- CAD / 335421
- Conditions
- Haemodialysis Patients, Colchicine, Feasibility Study
- Keywords
- Colchicine, Haemodialysis Patients, Feasibility Study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single-centre, single-armed feasibility study
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: Colchicine 0.5 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Anyone who is undergoing haemodialysis.
- Aged 18 or over
- Able to give informed consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 mgColchicine 0.5mg once a day orally for 3 months and 2 weeks | Drug | Colchicine |
Primary outcome
Feasibility to progress to a full-scale trial
Time frame: 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
Time frame: From enrolment to the end of treatment at 3 months and 2 weeks
Patients who continue colchicine until the end of the study.
4 secondary outcomes
Feasibility of data collection
Time frame: From enrolment to the end of treatment at 3 months and 2 weeks
Feasibility of data collection
Time frame: From enrolment to the end of treatment at 3 months and 2 weeks
Feasibility of data collection
Time frame: From enrolment to the end of treatment at 3 months and 2 weeks
Feasibility of data collection
Time frame: From enrolment to the end of treatment at 3 months and 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 34608832Richarz 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.
- Background: PubMed 25385362Wason 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.
- Background: PubMed 22874645Solak 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.
- Background: PubMed 32054504Stewart 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.
- Background: PubMed 34965168Deftereos 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.
- Background: PubMed 30042225Trerotola 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.
- Background: PubMed 33781793Karunanithy 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.
- Background: PubMed 32813949Lookstein 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.
- Background: PubMed 24587906Bountouris 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.
- Background: PubMed 11096150Turmel-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.
- Background: PubMed 25698092Aktas 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.
- Background: PubMed 21955605Heye 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.
- Individual participant dataSharing planned: Yes. Anonymised data and documentation generated from the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Michael Robson principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colchicine 0.5 mg in people with Haemodialysis Patients and Colchicine, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Dorothy Wong (+44 (0)20 7188 3563, dorothy.wong@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility to progress to a full-scale trial (time frame: From enrolment to the end of treatment at 3 months and 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07762807, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.