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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01145274
First received: June 15, 2010
Last updated: August 12, 2011
Last verified: August 2011
  Purpose

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


Condition
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study for PK/PD Parameter of Allopurinol and Its Metabolite-oxypurinol After Once-daily Allopurinol in Chronic Kidney Disease Patient

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Estimated Enrollment: 80
Study Start Date: June 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Detailed Description:

After the result of this pilot study, we can prescribe the optimal dose of allopurinol in CKD patient.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145274

Contacts
Contact: Ho Seok Koo, Dr 82-2-2072-2496 hoseok.koo@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ho Seok Koo, Dr    82-2-2072-2496    hoseok.koo@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Suhnggwon Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01145274     History of Changes
Other Study ID Numbers: Allopurinol_2010_1
Study First Received: June 15, 2010
Last Updated: August 12, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
allopurinol
chronic kidney diseae

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014