A study to assess if a large-scale clinical trial giving colchicine to dialysis patients is feasible

Colchicine and dialysis patients; a feasibility study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN91308625

Enrollment

100

Registered

2025-01-15

Start date

2025-04-01

Completion date

Unknown

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemodialysis Urological and Genital Diseases

Interventions

Colchicine 0.5 mg once daily orally will be given for 3 months and 2 weeks to all enrolled patients

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Anyone who is undergoing haemodialysis 2. Aged 18 years or over 3. Able to give informed consent

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The primary outcome is feasibility and the decision to progress to a full-scale trial based on: 1. Consent rate measured using the number of patients approached, screened, and included in the study over 1.5 years 2. Colchicine continuation rate measured using the number of patients who continued colchicine until the end of the study	—

Secondary

Measure	Time frame
1. To demonstrate the feasibility of data collection, including the following: 1.1. Health-related quality of life (QoL) measured using the EQ-5D-5L and vascular access-related QoL measured using the Vascular Access Specific Quality of life measure (VASQol) at baseline and study end 1.2. Vascular access events and interventions (radiological or surgical) measured using data collected in Case Report Forms throughout the study 1.3. Adverse events (including leukopenia, raised CK, gastrointestinal, and neurological) measured using data collected in Case Report Forms throughout the study. Feasibility will be considered to be demonstrated if complete data is collected for more than 80% of participants for each of the above outcomes. 2. To establish the utility of the EHR (electronic health records), a dataset from the EHR will be extracted and compared to the data entered into the eCRF database at the end of the study.	—

Measure

Time frame

1. To demonstrate the feasibility of data collection, including the following: 1.1. Health-related quality of life (QoL) measured using the EQ-5D-5L and vascular access-related QoL measured using the Vascular Access Specific Quality of life measure (VASQol) at baseline and study end 1.2. Vascular access events and interventions (radiological or surgical) measured using data collected in Case Report Forms throughout the study 1.3. Adverse events (including leukopenia, raised CK, gastrointestinal, and neurological) measured using data collected in Case Report Forms throughout the study. Feasibility will be considered to be demonstrated if complete data is collected for more than 80% of participants for each of the above outcomes. 2. To establish the utility of the EHR (electronic health records), a dataset from the EHR will be extracted and compared to the data entered into the eCRF database at the end of the study.

—

Countries

England, United Kingdom

Contacts

Public ContactYuen Ting Dorothy Wong

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 23, 2026