Chronic Kidney DiseaseAllopurinolNCT01145274
A Pilot Study for Pharmacokinetic/Pharmacodynamic (PK/PD) Parameter of Allopurinol and Its Metabolite-oxypurinol After Once-daily Allopurinol in Chronic Kidney Disease Patient
An observational study of Chronic Kidney Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To know the blood level of allopurinol in chronic kidney disease (CKD) patient. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: chronic kidney disease ( estimated GFR 30-60 ml/min )
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Seoul
Ho Seok Koo, Dr, 82-2-2072-2496, hoseok.koo@gmail.com
About this study
Official title: 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.
Read the detailed description
After the result of this pilot study, we can prescribe the optimal dose of allopurinol in CKD patient.
- Conditions
- Chronic Kidney Disease
- Keywords
- allopurinol, chronic kidney diseae
- Medical subject headings
- Renal Insufficiency, Chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145274
- Sponsor's protocol ID
- Allopurinol_2010_1
- Acronym
- Allopurinol
- Status last verified
- Aug 2011
- First submitted
- 15 Jun 2010
- Last updated
- 16 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for PK/PD Parameter of Allopurinol and Its Metabolite-oxypurinol After Once-daily Allopurinol in Chronic Kidney Disease Patient
- ClinicalTrials.gov ID
- NCT01145274
- Acronym / sponsor ID
- Allopurinol / Allopurinol_2010_1
- Conditions
- Chronic Kidney Disease
- Keywords
- allopurinol, chronic kidney diseae
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 16 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To know the blood level of allopurinol in chronic kidney disease (CKD) patient.
Detailed description
After the result of this pilot study, we can prescribe the optimal dose of allopurinol in CKD patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic kidney disease ( estimated GFR 30-60 ml/min )
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho Seok Koo, Dr (82-2-2072-2496, hoseok.koo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2011.