A Pilot Study for PK/PD Parameter of Colchicine in Chronic Kidney Disease Patient.

Chronic Kidney Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173107
• Other study ID #: Colchicine_2010_1
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2010
• Last updated: December 27, 2010
• Start date: December 2010

Study information

• Verified date: December 2010
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A pilot study for PK/PD parameter of colchicine in Chronic kidney disease patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• from 18yrs to 80yrs , man and women

• the patient who are taking colchicine

• On screening, the patient shows that MDRD GFR >= 10 ml/min and <= 50 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

• 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

• pregnancy or anticipate pregnancy with 6 month

• hypersensitivity to colchicine

• 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 colchicine

• 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 Atazanavir, Amprenavir, Apreptant, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, verapamil, cyclosporine, ranolazine

• the patient who had taken part in the other study within 3months

• the patient who had gotten blood transfusion

• pregnant, breast feeding

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Intervention

Drug:
• colchicine
colchicine 1T tid

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum colchicine level		0,1,6 hours	Yes