Chronic Kidney Disease
Conditions
Brief summary
A pilot study for PK/PD parameter of colchicine in Chronic kidney disease patient.
Interventions
DRUGcolchicine
colchicine 1T tid
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum colchicine level | 0,1,6 hours |
Countries
South Korea
Outcome results
None listed