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EFFICACY OF COLCHICINE IN SECONDARY PREVENTION OF VASCULAR EVENTS AND RENAL PROGRESSION IN PATIENTS WITH MODERATE CHRONIC RENAL DISEASE (COLCHIREN STUDY).

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505868-11-00
Acronym
FIBHGM-ECNC002-2022
Enrollment
744
Registered
2024-04-17
Start date
2025-01-17
Completion date
Unknown
Last updated
2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHRONIC RENAL DISEASE

Brief summary

incidence of the primary event consisting of: death from cardiovascular causes; acute coronary syndrome; angina requiring hospitalisation; coronary revascularisation; transient ischaemic attack or non-cardioembolic ischaemic stroke; or peripheral vascular disease, defined as acute peripheral arterial embolism or ischaemia, or the need for amputation or percutaneous surgical revascularisation, Incidence of primary event consisting of death from cardiovascular causes; acute coronary syndrome; angina requiring hospitalization; coronary revascularization; transient ischemic attack or noncardioembolic ischemic stroke; or peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or need for amputation or surgical or percutaneous revascularization.

Detailed description

- Incidence of death from cardiovascular causes. - Incidence of acute coronary syndrome. - Incidence of hospitalization for cardiac angina. - Incidence of coronary revascularization. - Incidence of transient ischemic attack or noncardioembolic ischemic stroke. - Incidence of peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or need for amputation or percutaneous surgical revascularization., - Individual and combined incidence of renal events: o 40% decrease in glomerular filtration rate estimated by CKD-EPI with respect to baseline. o Doubling of serum creatinine over its baseline level. o Persistent drop in glomerular filtration rate estimated by CKD-EPI below 15 mL/min/1.73m2. o Need for renal replacement therapy on a sustained basis. - Effect on plasma levels of markers of inflammation, fibrosis and renal progression. - Incidence of adverse events.

Interventions

DRUGclochicine
DRUGCOLCHICINE

Sponsors

Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
incidence of the primary event consisting of: death from cardiovascular causes; acute coronary syndrome; angina requiring hospitalisation; coronary revascularisation; transient ischaemic attack or non-cardioembolic ischaemic stroke; or peripheral vascular disease, defined as acute peripheral arterial embolism or ischaemia, or the need for amputation or percutaneous surgical revascularisation, Incidence of primary event consisting of death from cardiovascular causes; acute coronary syndrome; angina requiring hospitalization; coronary revascularization; transient ischemic attack or noncardioembolic ischemic stroke; or peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or need for amputation or surgical or percutaneous revascularization.

Secondary

MeasureTime frame
- Incidence of death from cardiovascular causes. - Incidence of acute coronary syndrome. - Incidence of hospitalization for cardiac angina. - Incidence of coronary revascularization. - Incidence of transient ischemic attack or noncardioembolic ischemic stroke. - Incidence of peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or need for amputation or percutaneous surgical revascularization., - Individual and combined incidence of renal events: o 40% decrease in glomerular filtration rate estimated by CKD-EPI with respect to baseline. o Doubling of serum creatinine over its baseline level. o Persistent drop in glomerular filtration rate estimated by CKD-EPI below 15 mL/min/1.73m2. o Need for renal replacement therapy on a sustained basis. - Effect on plasma levels of markers of inflammation, fibrosis and renal progression. - Incidence of adverse events.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026