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Optimal Administration of Allopurinol in Dialysis Patients

Primary Purpose

Gout, Renal Insufficiency

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Allopurinol

About this trial

This is an interventional prevention trial for Gout focused on measuring Allopurinol, Renal Dialysis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Maisonneuve-Rosemont Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allopurinol HS

Arm Description

Allopurinol at bedtime compared to AM administration

Outcomes

Primary Outcome Measures

Change in uric acid levels from baseline

Compare the efficacy of allopurinol when given before versus after dialysis

Secondary Outcome Measures

Full Information

NCT ID

NCT02477488

First Posted

June 17, 2015

Last Updated

September 12, 2016

Sponsor

Maisonneuve-Rosemont Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02477488

Brief Title

Optimal Administration of Allopurinol in Dialysis Patients

Official Title

Optimal Administration of Allopurinol in Dialysis Patients : A Chronotherapy Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Maisonneuve-Rosemont Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gout, Renal Insufficiency

Keywords

Allopurinol, Renal Dialysis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Allopurinol HS

Arm Type

Experimental

Arm Description

Allopurinol at bedtime compared to AM administration

Intervention Type

Drug

Intervention Name(s)

Allopurinol

Other Intervention Name(s)

Zyloprim

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in uric acid levels from baseline

Description

Compare the efficacy of allopurinol when given before versus after dialysis

Time Frame

6 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michel Vallée, MD, PhD

Organizational Affiliation

Maisonneuve-Rosemont Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maisonneuve-Rosemont Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

18508965

Citation

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.

Results Reference

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Learn more about this trial

Optimal Administration of Allopurinol in Dialysis Patients

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