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
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.
|
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.
|
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
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
- Metabolic Diseases
- Kidney Diseases
- Urologic Diseases
- Genetic Diseases, Inborn
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Metabolism, Inborn Errors
- Crystal Arthropathies
- Purine-Pyrimidine Metabolism, Inborn Errors
- Renal Insufficiency
- Gout
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Gout Suppressants
- Colchicine
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.