Optimal Administration of Allopurinol in Dialysis Patients

Renal Insufficiency Clinical Trial

Official title:

Optimal Administration of Allopurinol in Dialysis Patients : A Chronotherapy Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477488
• Other study ID #: 14106
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2015
• Last updated: September 12, 2016
• Start date: June 2015
• Est. completion date: August 2015

Study information

• Verified date: September 2016
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Gout has a strong association with the metabolic syndrome, and it is often seen in patients with renal insufficiency. Allopurinol is a medication intended to lower uric acid and therefore prevents gout attacks. Its metabolism is mainly renal, and some evidence shows that it is also dialyzable. The hypothesis is that allopurinol would be more efficacious to lower uric acid if it was given after dialysis only. The investigators will then switch administration of allopurinol to bedtime for dialysis patients currently taking that medication.

Description:

Gout has a strong association with the metabolic syndrome, and it is often seen in patients with renal insufficiency. A study has shown an incidence of fifteen percent of gout in the first five years spent in dialysis and it was associated with an increased mortality. Allopurinol is a medication intended to lower uric acid and therefore prevents gout attacks. Its metabolism is mainly renal, and some studies from the early 1960s demonstrated that it is also dialyzable. At the moment, we do not have strong evidence of the optimal dosage of allopurinol with modern techniques of dialysis. The hypothesis is that allopurinol would be more efficacious to lower uric acid if it was given after dialysis only. The investigators will then switch administration of allopurinol to bedtime for dialysis patients currently taking that medication. Dosage of uric acid will be performed to assess the efficacy of the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects who receive chronic treatments of hemodialysis at Maisonneuve-Rosemont Hospital

• Subjects who take allopurinol for at least a month

Exclusion Criteria:

• Subjects who have had an acute gout attack in the past month

• Subjects with tumor lysis syndrome

• Sujects who have a history of hypersensitivity reaction to allopurinol

• Subjects with hepatic insufficiency

• Women who are pregnant or planning to become pregnant in the next three months

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gout
• Renal Insufficiency

Intervention

Drug:
• Allopurinol
Administration of allopurinol is changed to bedtime (hs) for each patient, at the same dosage as was previously prescribed.

Locations

Country	Name	City	State
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Cohen SD, Kimmel PL, Neff R, Agodoa L, Abbott KC. Association of incident gout and mortality in dialysis patients. J Am Soc Nephrol. 2008 Nov;19(11):2204-10. doi: 10.1681/ASN.2007111256. Epub 2008 May 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in uric acid levels from baseline	Compare the efficacy of allopurinol when given before versus after dialysis	6 weeks	No