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

• Sponsor: En Chu Kong Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05006001
• Collaborator: (none)
• Enrollment: 2,000
• Anticipated Duration (Months): 156

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Impairment; Gout; Colchicine Adverse Reaction; Nonsteroidals (NSAIDs)Toxicity	Drug: Colchicine and NSAID

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 Design

• Study Type: Observational
• Anticipated Enrollment: 2000 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Evaluation of Colchicine and Nonsteroidal Anti-inflammatory Drug Combination Therapy and Renal Function in Gout Patients
• Actual Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Acute kidney injury [Through study completion, an average of 1 year]

   Number of participants with a diagnosis of acute kidney injury

Secondary Outcome Measures

1. All cause mortality [Through study completion, an average of 1 year]

   Number of participants with a death record

2. Hemodialysis or peritoneal dialysis [Through study completion, an average of 1 year]

   Number of participants with a dialysis record

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• En Chu Kong Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ya-Ling Huang, Principal Investigator, En Chu Kong Hospital
• ClinicalTrials.gov Identifier: NCT05006001
• Other Study ID Numbers: EnChuKongH
• First Posted: Aug 16, 2021
• Last Update Posted: Aug 16, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Keywords provided by Ya-Ling Huang, Principal Investigator, En Chu Kong Hospital: Acute kidney injury; Renal impairment; Nonsteroidal antiinflammatory drug; Drug-drug interaction
• Additional relevant MeSH terms: Gout; Renal Insufficiency; Colchicine

Study Results

No Results Posted as of Aug 16, 2021