Chronic Kidney DiseasePhase 2NCT01932268
A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin
A Phase 2 study testing Rifampicin in people with Chronic Kidney Disease and Tuberculosis, run by Seoul National University Hospital.
Trial summary
The purpose of this study is to examine the colchicine concentration before and after the administration of rifampicin. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, Tuberculosis
- What is being tested?
- Rifampicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2011
- Phase
- Phase 2
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- from 18yrs to 80yrs , man and women
- the patient who are taking rifampicine over 2weeks
- 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 hypersensitivity to colchicine
- 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
- serum albumin < 3.5, > 5 g/dL
- 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
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- 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
About this study
The purpose of this study is to examine the colchicine concentration before and after the administration of rifampicin.
- Conditions
- Chronic Kidney Disease, Tuberculosis
- Being tested
- Rifampicin
- Medical subject headings
- Renal Insufficiency, Chronic, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifampicinDrug
Also called Rifampin
single arm : check a change of Colchicine concentrations from basline at 1,2,4,8,24 hours after Rifampicin administration
| Study group | Role | What they receive |
|---|---|---|
| Rifampicin | Experimental | experimentally check a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after taking Rifampicin Receives: Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after Rifampicin administration
Measured: the colchicine concentration of baseline(C0) and at 1(C1),2(C2),4(C4),8(C8),24(C24) hours after Rifampicin administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932268
- Sponsor's protocol ID
- Colchicine_RFP 2011_1
- Status last verified
- Aug 2013
- First submitted
- 7 Dec 2011
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin
- ClinicalTrials.gov ID
- NCT01932268
- Acronym / sponsor ID
- Colchicine_RFP 2011_1
- Conditions
- Chronic Kidney Disease, Tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Aug 2013 (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.
The purpose of this study is to examine the colchicine concentration before and after the administration of rifampicin.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rifampicin | Experimental | Drug: Rifampicinexperimentally check a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after taking Rifampicin |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- from 18yrs to 80yrs , man and women
- the patient who are taking rifampicine over 2weeks
- the patient sign on the concent form
Key exclusion criteria (11 listed)
- the patient have experience to take medication that have an effect on renal function
- the patient have hypersensitivity to colchicine
- 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
- serum albumin < 3.5, > 5 g/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RifampicinAlso: Rifampinsingle arm : check a change of Colchicine concentrations from basline at 1,2,4,8,24 hours after Rifampicin administration | Drug | Rifampicin |
Primary outcome
a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after Rifampicin administration
Time frame: the colchicine concentration of baseline(C0) and at 1(C1),2(C2),4(C4),8(C8),24(C24) hours after Rifampicin administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rifampicin in people with Chronic Kidney Disease and Tuberculosis, run by Seoul National University Hospital.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after Rifampicin administration (time frame: the colchicine concentration of baseline(C0) and at 1(C1),2(C2),4(C4),8(C8),24(C24) hours after Rifampicin administration). It is what the study was designed to measure, not a finding.
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 30 Aug 2013.