- Demonstrating an association between oxypurinol concentration and the chance of succesfull lowering of urate concentration in gouty patients (defined as reaching urate concentrations < 0,30 mmol/l)
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Aandoening van het bewegingsapparaat
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- association between oxypurinol concentration and the chance on succesfull
treatment of gout (defined as
reaching urate concentrations of <0,30 mmol/l)
Secondary outcome
- association between oxypurinol concentration and the risk of getting adverse
drug reactions
- association between oxypurinol concentration and the chance on succesfull
treatment of gout (defined as
reaching urate concentrations of <0,36 mmol/l)
- percentage of patients succesfully treated with the proposed dosage nomogram
- the role of genetic variations on the occurence of adverse reactions
Background summary
Treatment of gouty patients with allopurinol is contemporary on basis of the
applying guidelines. Allopurinol is well-thought-of in treating gout. When
urate lowering is insufficient allopurinol dosage should be raised untill the
maximum dosage of 900 mg per day. Own research shows that only 25% of gouty
patients is succesfull in reaching urate concentration <0,30 mmol/l with an
allopurinol dosage of 300 mg per day.
The active metabolite of allopurinol is oxypurinol. The registration holder of
allopurinol advises to measure the oxypurinolconcentration in case of impaired
renal function. The oxypurinolconcencentration should be beneath 15,2 mg/l to
avoid adverse effects. Common practice shows that oxypurinolconcentrations are
seldom measured.
Study objective
- Demonstrating an association between oxypurinol concentration and the chance
of succesfull lowering of urate concentration in gouty patients (defined as
reaching urate concentrations < 0,30 mmol/l)
Study design
Patients diagnosed with gout and being treated with allopurinol are included.
Dosing of allopurinol based on a dose nomogram for patients with impaired renal
function. De dosage varies from 100 - 600 mg per day. Two and four months after
starting allopurinol oxypurinolconcentrations and serumurate are measured.
Study burden and risks
not applicable
H. dunantweg 2
8934 AD
NL
H. dunantweg 2
8934 AD
NL
Listed location countries
Age
Inclusion criteria
1. Confirmed gout with urate crystals or tophi
2. First treatment with allopurinol
3. Filled and signed informed consent
Exclusion criteria
1. Patients younger than 18 years and pregnant women
2. Patients with eGFR <20 ml/min
3. Patients using azathioprine, mercaptopurine or cyclofosfamide
4. patients with elevated liverenzymes, defined as more than twice baseline ASAT or ALAT values
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-011260-10-NL |
| CCMO | NL27230.099.09 |