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)

August 12, 2011 updated by: Seoul National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

June 15, 2010

First Submitted That Met QC Criteria

June 15, 2010

First Posted (Estimate)

June 16, 2010

Study Record Updates

Last Update Posted (Estimate)

August 16, 2011

Last Update Submitted That Met QC Criteria

August 12, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Allopurinol_2010_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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