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Optimal Administration of Allopurinol in Dialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02477488
Recruitment Status : Completed
First Posted : June 22, 2015
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Michel Vallée, Maisonneuve-Rosemont Hospital

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.

Condition or disease Intervention/treatment Phase
Gout Renal Insufficiency Drug: Allopurinol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimal Administration of Allopurinol in Dialysis Patients : A Chronotherapy Trial
Study Start Date : June 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Dialysis Gout

Arm Intervention/treatment
Experimental: Allopurinol HS
Allopurinol at bedtime compared to AM administration
Drug: Allopurinol
Administration of allopurinol is changed to bedtime (hs) for each patient, at the same dosage as was previously prescribed.
Other Name: Zyloprim




Primary Outcome Measures :
  1. Change in uric acid levels from baseline [ Time Frame: 6 weeks ]
    Compare the efficacy of allopurinol when given before versus after dialysis



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477488


Locations
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Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Investigators
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Principal Investigator: Michel Vallée, MD, PhD Maisonneuve-Rosemont Hospital

Publications:
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Responsible Party: Michel Vallée, Nephrologist, M.D., Ph.D., FRCP(C), Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT02477488    
Other Study ID Numbers: 14106
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Keywords provided by Michel Vallée, Maisonneuve-Rosemont Hospital:
Allopurinol
Renal Dialysis
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs