Status:
UNKNOWN
A Pilot Study for Pharmacokinetic/Pharmacodynamic (PK/PD) Parameter of Allopurinol and Its Metabolite-oxypurinol After Once-daily Allopurinol in Chronic Kidney Disease Patient
Lead Sponsor:
Seoul National University Hospital
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18-80 years
Brief Summary
To know the blood level of allopurinol in chronic kidney disease (CKD) patient.
Detailed Description
After the result of this pilot study, we can prescribe the optimal dose of allopurinol in CKD patient.
Eligibility Criteria
Inclusion
- from 18yrs to 80yrs , man and women
- the patient who are taking allopurinol
- On screening, the patient shows that the level of protein/creatinine ratio is over 3.0
- On screening, the patient shows that MDRD GFR \>= 30 ml/min and \<= 60 ml/min
- the patient sign on the concent form
Exclusion
- the patient have experience to take medication that have an effect on renal function
- the patient have experience to take cyclosporin within 3month
- 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
- uncontrolled hypertension
- pregnancy or anticipate pregnancy with 6 month
- hypersensitivity to allopurinol
- 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 allopurinol
- 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 azathioprine, mercaptopurine, cyclophosphamide, Losartan, benzbromarone,fenofibrate,furosemide ,probenecid
- 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 :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01145274
Start Date
June 1 2010
End Date
February 1 2013
Last Update
August 16 2011
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Seoul, South Korea