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

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

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: colchicine

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MDRD eGFR 10~50 ml/min/1.73m2	Drug: colchicine; colchicine 1T tid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
serum colchicine level	0,1,6 hours

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: July 28, 2010
• First Submitted That Met QC Criteria: July 28, 2010
• First Posted (Estimate): July 30, 2010

Study Record Updates

• Last Update Posted (Estimate): December 29, 2010
• Last Update Submitted That Met QC Criteria: December 27, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: Colchicine_2010_1