Evaluation of Colchicine and Nonsteroidal Anti-inflammatory Drug Combination Therapy and Renal Function in Gout Patients

August 12, 2021 updated by: Ya-Ling Huang, En Chu Kong Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Gout is a common prevalent disease, which causes a low quality of life and poses a significant health burden nationally and internationally. Colchicine and Nonsteroidal anti-inflammatory drug (NSAID) are the mainstay treatment of gout. Concurrent use of colchicine and NSAIDs are more than half in all prescriptions of the gout patients. Both colchicine and NSAIDs may cause renal impairment. However, the empirical evidence of renal impairment of colchicine and NSAIDs combination therapy is limited and even absent.

Objectives: This proposal will assess the association between colchicine and NSAIDs combination therapy and acute kidney injury. The investigators further evaluate the relationships of duration-response, recency-response, and dose-response.

Study Type

Observational

Enrollment (Anticipated)

2000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with gout and initiating anti-gout drug

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • <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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case
Cases were defined as patients with an event of renal impairment during follow-up, such as acute kidney injury.
Drug: Colchicine and NSAID
Colchicine and nonsteroidal anti-inflammatory drug combination therapy
Control
Cases were defined as patients without an event of renal impairment during follow-up, such as acute kidney injury.
Drug: Colchicine and NSAID
Colchicine and nonsteroidal anti-inflammatory drug combination therapy
Exposure
Exposure was defined as patients with colchicine and NSAIDs combination therapy.
Non-Exposure
Non-Exposure was defined as patients with other gout therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury
Time Frame: Through study completion, an average of 1 year
Number of participants with a diagnosis of acute kidney injury
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: Through study completion, an average of 1 year
Number of participants with a death record
Through study completion, an average of 1 year
Hemodialysis or peritoneal dialysis
Time Frame: Through study completion, an average of 1 year
Number of participants with a dialysis record
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

En Chu Kong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 31, 2019

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EnChuKongH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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