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 | Unknown

• 1 other identifier: Allopurinol_2010_1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To know the blood level of allopurinol in chronic kidney disease (CKD) patient.

Conditions

Chronic Kidney Disease

Keywords

allopurinol; chronic kidney diseae

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

chronic kidney disease ( estimated GFR 30-60 ml/min )

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ho Seok Koo, Dr

CONTACT

82-2-2072-2496; hoseok.koo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: June 16, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 16, 2011

Record last verified: 2011-08

Locations

KR (1)