Renal ImpairmentNCT05006001
Evaluation of Colchicine and Nonsteroidal Anti-inflammatory Drug Combination Therapy and Renal Function in Gout Patients
An observational study of Renal Impairment and Gout, run by En Chu Kong Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment, Gout, Colchicine Adverse Reaction
- What is being tested?
- Colchicine and NSAID
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with gout and initiating anti-gout drug
Who may be able to join
- Clinical diagnosis of a gout diagnosis
- Initially receiving at least one anti-gout drug
Who cannot join
- <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
About this study
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.
Read the 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.
- Being tested
- Colchicine and NSAID
- Keywords
- Acute kidney injury, Renal impairment, Nonsteroidal antiinflammatory drug, Drug-drug interaction
- Medical subject headings
- Renal Insufficiency, Gout, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine and NSAIDDrug
Colchicine and nonsteroidal anti-inflammatory drug combination therapy
| Study group | Role | What they receive |
|---|---|---|
| Case | Cases were defined as patients with an event of renal impairment during follow-up, such as acute kidney injury. Receives: Drug: Colchicine and NSAID | |
| Control | Cases were defined as patients without an event of renal impairment during follow-up, such as acute kidney injury. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
Number of participants with a diagnosis of acute kidney injury
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
All cause mortality
Number of participants with a death record
Measured: Through study completion, an average of 1 year
Hemodialysis or peritoneal dialysis
Number of participants with a dialysis record
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Jan 2012
- Primary completion31 Dec 2019
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- En Chu Kong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ling Huang, En Chu Kong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006001
- Sponsor's protocol ID
- EnChuKongH
- Status last verified
- Aug 2021
- First submitted
- 27 May 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Colchicine and Nonsteroidal Anti-inflammatory Drug Combination Therapy and Renal Function in Gout Patients
- ClinicalTrials.gov ID
- NCT05006001
- Acronym / sponsor ID
- EnChuKongH
- Keywords
- Acute kidney injury, Renal impairment, Nonsteroidal antiinflammatory drug, Drug-drug interaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- En Chu Kong HospitalUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Case | – | Drug: Colchicine and NSAIDCases were defined as patients with an event of renal impairment during follow-up, such as acute kidney injury. |
| Control | – | Drug: Colchicine and NSAIDCases were defined as patients without an event of renal impairment during follow-up, such as acute kidney injury. |
| Exposure | – | –Exposure was defined as patients with colchicine and NSAIDs combination therapy. |
| Non-Exposure | – | –Non-Exposure was defined as patients with other gout therapy. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with gout and initiating anti-gout drug
Key inclusion criteria (2 listed)
- Clinical diagnosis of a gout diagnosis
- Initially receiving at least one anti-gout drug
Key exclusion criteria (4 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine and NSAIDColchicine and nonsteroidal anti-inflammatory drug combination therapy | Drug | Case, Control |
Primary outcome
Acute kidney injury
Time frame: Through study completion, an average of 1 year
Number of participants with a diagnosis of acute kidney injury
2 secondary outcomes
All cause mortality
Time frame: Through study completion, an average of 1 year
Hemodialysis or peritoneal dialysis
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Impairment and Gout, run by En Chu Kong Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.