None listed
Conditions
Brief summary
Gout is a painful form of arthritis caused by urate crystal deposition and is common in people with kidney failure receiving haemodialysis. Allopurinol is routinely prescribed to lower urate levels and prevent flares. However, haemodialysis itself removes urate, raising the possibility that some patients may no longer require allopurinol.. This pilot study will evaluate whether gradually stopping allopurinol is safe, effective, and feasible in haemodialysis patients with well-controlled gout. Participants will undergo stepwise dose reduction with regular blood tests and receive medication to prevent gout flares during the process. If a flare occurs, dose reduction will be stopped and usual treatment resumed. The study aims to reduce medication burden in this population and inform the design of a larger clinical trial and future clinical guidelines.
Interventions
In consenting participants, allopurinol doses will be gradually reduced in a stepwise manner by 50 mg per month until complete discontinuation. Serum urate concentrations will be measured pre-dialysis at baseline and two weeks after each dose reduction. Following discontinuation, participants will be monitored monthly for six months. Deprescribing of allopurinol will occur over 2-7 months (depending on the initial dose), followed by a 6-month follow up period. The overall duration of the interve
In consenting participants, allopurinol doses will be gradually reduced in a stepwise manner by 50 mg per month until complete discontinuation. Serum urate concentrations will be measured pre-dialysis at baseline and two weeks after each dose reduction. Following discontinuation, participants will be monitored monthly for six months. Deprescribing of allopurinol will occur over 2-7 months (depending on the initial dose), followed by a 6-month follow up period. The overall duration of the intervention period is between 8 and 15 months. Gout flares will be assessed using validated Gaffo’s criteria, defined by the presence of three or more of the following: patient-defined flare, pain at rest greater than 3 on a 0–10 scale, at least one swollen joint, and at least one warm joint. To minimise the risk of gout flares during deprescribing, participants will receive prophylaxis as determined by the treating nephrologist. This may include colchicine 250 micrograms twice weekly, or a short course of prednisolone 12.5–25 mg for 3 days at each dose reduction. Participants receiving colchicine will undergo monitoring for gastrointestinal adverse effects and periodic full blood count testing. If a gout flare or significant adverse event occurs, deprescribing will be paused and participation will cease. Allopurinol may be re-initiated at the discretion of the treating clinician in accordance with standard care. All study procedures will be embedded within routine haemodialysis care, with blood sampling incorporated into standard pre-dialysis testing to minimise participant burden.
Sponsors
The University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients with end-stage CKD and controlled chronic gouty arthritis, currently prescribed allopurinol, receiving haemodialysis for at least 4 weeks will be potentially eligible. Chronic gouty arthritis is defined by the Gout, Hyperuricemia and Crystal-Associated Disease Network as persistent joint inflammation induced by monosodium urate crystals. Controlled gout will be defined as maximum of one gout flare in last 6 months. Pre-dialysis serum urate concentrations will be measured for potentially eligible participants and only participants with serum urate less than or equal to 0.36 mmol/L will be included.
Exclusion criteria
Presence of gouty tophi, planned kidney transplant, or conversion to peritoneal dialysis within one year. Patients unable to give consent will also be excluded. Tophi would be identified using physical measurement techniques as required by the framework of the Outcomes Measures in Rheumatology (OMERACT)
Outcome results
None listed