A Pilot Study for Pharmacokinetic/Pharmacodynamic (PK/PD) Parameter of Allopurinol and Its Metabolite-oxypurinol After Once-daily Allopurinol in Chronic Kidney Disease Patient (Allopurinol)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01145274
Recruitment Status : Unknown
Verified August 2011 by Seoul National University Hospital. Recruitment status was: Recruiting
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
chronic kidney disease ( estimated GFR 30-60 ml/min )
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
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
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