Clinical trial: A Pilot Study for Pharmacokinetic/Pharmacodynamic (PK/PD) Parameter of Allopurinol and Its Metabolite-oxypurinol After Once-daily Allopurinol in Chronic Kidney Disease Patient (NCT01145274)

Eligibility criteria:
Inclusion Criteria:

          -  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 Criteria:

          -  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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain.  The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint.  Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis.

Patient description (patient's own words): I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis.

Does the patient match the trial criteria? Contradiction