NCT02477488

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

2 months

First QC Date

June 17, 2015

Last Update Submit

September 12, 2016

Conditions

GoutRenal Insufficiency

Keywords

AllopurinolRenal Dialysis

Outcome Measures

Primary Outcomes (1)

  • Change in uric acid levels from baseline

    Compare the efficacy of allopurinol when given before versus after dialysis

    6 weeks

Study Arms (1)

Allopurinol HS

EXPERIMENTAL

Allopurinol at bedtime compared to AM administration

Drug: Allopurinol

Interventions

AllopurinolDRUG

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

Also known as: Zyloprim
Allopurinol HS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who receive chronic treatments of hemodialysis at Maisonneuve-Rosemont Hospital
  • Subjects who take allopurinol for at least a month

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Related 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.

    PMID: 18508965BACKGROUND

MeSH Terms

Conditions

GoutRenal Insufficiency

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Michel Vallée, MD, PhD

    Maisonneuve-Rosemont Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nephrologist, M.D., Ph.D., FRCP(C)

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 22, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 13, 2016

Record last verified: 2016-09

Locations

CA(1)