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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
colchicine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MDRD eGFR 10~50 ml/min/1.73m2

Arm Description

Outcomes

Primary Outcome Measures

serum colchicine level

Secondary Outcome Measures

Full Information

First Posted
July 28, 2010
Last Updated
December 27, 2010
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01173107
Brief Title
A Pilot Study for PK/PD Parameter of Colchicine in Chronic Kidney Disease Patient.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MDRD eGFR 10~50 ml/min/1.73m2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
colchicine
Intervention Description
colchicine 1T tid
Primary Outcome Measure Information:
Title
serum colchicine level
Time Frame
0,1,6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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 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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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