A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin

Chronic Kidney Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932268
• Other study ID #: Colchicine_RFP 2011_1
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2011
• Last updated: August 26, 2013
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: August 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the colchicine concentration before and after the administration of rifampicin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Tuberculosis

Intervention

Drug:
• Rifampicin
single arm : check a change of Colchicine concentrations from basline at 1,2,4,8,24 hours after Rifampicin administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after Rifampicin administration		the colchicine concentration of baseline(C0) and at 1(C1),2(C2),4(C4),8(C8),24(C24) hours after Rifampicin administration	No