NCT05006001

Brief Summary

Our findings are expected to provide real-world evidence of the renal-adverse effects of colchicine and NSAIDs combination therapy in patients with gout, which will guide healthcare professions in optimizing gout treatment regimens and evaluating risks of renal impairment.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

8 years

First QC Date

May 27, 2021

Last Update Submit

August 12, 2021

Conditions

Renal ImpairmentGoutColchicine Adverse ReactionNonsteroidals (NSAIDs)Toxicity

Keywords

Acute kidney injuryRenal impairmentNonsteroidal antiinflammatory drugDrug-drug interaction

Outcome Measures

Primary Outcomes (1)

  • Acute kidney injury

    Number of participants with a diagnosis of acute kidney injury

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • All cause mortality

    Through study completion, an average of 1 year

  • Hemodialysis or peritoneal dialysis

    Through study completion, an average of 1 year

Study Arms (4)

Case

Cases were defined as patients with an event of renal impairment during follow-up, such as acute kidney injury.

Drug: Colchicine and NSAID

Control

Cases were defined as patients without an event of renal impairment during follow-up, such as acute kidney injury.

Drug: Colchicine and NSAID

Exposure

Exposure was defined as patients with colchicine and NSAIDs combination therapy.

Non-Exposure

Non-Exposure was defined as patients with other gout therapy.

Interventions

Colchicine and NSAIDDRUG

Colchicine and nonsteroidal anti-inflammatory drug combination therapy

CaseControl

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with gout and initiating anti-gout drug

You may qualify if:

  • Clinical diagnosis of a gout diagnosis
  • Initially receiving at least one anti-gout drug

You may not qualify if:

  • \<1 year of continuous health insurance enrollment
  • Colchicine and NSAID use before the cohort entry date
  • Patients with hemodialysis or peritoneal dialysis before the cohort entry date
  • Patients with acute kidney injury before the cohort entry date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal InsufficiencyGoutAcute Kidney Injury

Interventions

ColchicineAnti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic CompoundsAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic Agents

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2021

First Posted

August 16, 2021

Study Start

January 1, 2012

Primary Completion

December 31, 2019

Study Completion

December 31, 2024

Last Updated

August 16, 2021

Record last verified: 2021-08