A Pilot Study for PK/PD Parameter of Colchicine in Chronic Kidney Disease Patient.
NCT ID: NCT01173107
Last Updated: 2010-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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MDRD eGFR 10~50 ml/min/1.73m2
colchicine
colchicine 1T tid
Interventions
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colchicine
colchicine 1T tid
Eligibility Criteria
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Inclusion Criteria
* the patient who are taking colchicine
* On screening, the patient shows that MDRD GFR \>= 10 ml/min and \<= 50 ml/min
* the patient sign on the concent form
Exclusion Criteria
* At least, the average level of two separate blood pressure ( 2min interval ) shows that SBP \<= 100 mmHg or \>=160 mmHg and DBP \<=60 mmHg \>=100 mmHg, or Heart rate \< 40 beats/min or \> 90 beats/min
* pregnancy or anticipate pregnancy with 6 month
* hypersensitivity to colchicine
* acute hepatitis or the level of AST or ALT is over 2times of normal range or the level of bilirubin is over 2.0 mg/dL
* serum albumin \< 3.5 mg/dL or \> 5mg/dL
* urinary retension, prostatic hyperplasia
* the patient show gout attack on taking colchicine
* the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine.
* the patient who should take Atazanavir, Amprenavir, Apreptant, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil, cyclosporine, ranolazine
* the patient who had taken part in the other study within 3months
* the patient who had gotten blood transfusion
* pregnant, breast feeding
18 Years
80 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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Colchicine_2010_1
Identifier Type: -
Identifier Source: org_study_id