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

Phase 4

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: colchicine

• Registration Number: NCT01173107
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-28
• Study First Posted: 2010-07-30
• Status Verified: 2010-12
• Study Start: 2010-12
• Primary Completion: 2010-12
• Last Update Submitted: 2010-12-27
• Last Update Posted: 2010-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MDRD eGFR 10~50 ml/min/1.73m2	colchicine	-

Primary Outcome Measures

Name	Time	Method
serum colchicine level	0,1,6 hours

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of