A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin
Primary Purpose
Chronic Kidney Disease, Tuberculosis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Rifampicin
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- from 18yrs to 80yrs , man and women
- the patient who are taking rifampicine over 2weeks
- 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 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rifampicin
Arm Description
experimentally check a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after taking Rifampicin
Outcomes
Primary Outcome Measures
a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after Rifampicin administration
Secondary Outcome Measures
Full Information
NCT ID
NCT01932268
First Posted
December 7, 2011
Last Updated
August 26, 2013
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01932268
Brief Title
A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the colchicine concentration before and after the administration of rifampicin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Tuberculosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rifampicin
Arm Type
Experimental
Arm Description
experimentally check a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after taking Rifampicin
Intervention Type
Drug
Intervention Name(s)
Rifampicin
Other Intervention Name(s)
Rifampin
Intervention Description
single arm : check a change of Colchicine concentrations from basline at 1,2,4,8,24 hours after Rifampicin administration
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
from 18yrs to 80yrs , man and women
the patient who are taking rifampicine over 2weeks
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 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
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
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin
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