Status:
COMPLETED
A Pilot Study for PK/PD Parameter of Colchicine in Chronic Kidney Disease Patient.
Lead Sponsor:
Seoul National University Hospital
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
A pilot study for PK/PD parameter of colchicine in Chronic kidney disease patient.
Eligibility Criteria
Inclusion
- from 18yrs to 80yrs , man and women
- 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
- the patient have experience to take medication that have an effect on renal function
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01173107
Start Date
December 1 2010
Last Update
December 29 2010
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Seoul, South Korea