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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01173107
Recruitment Status : Completed
First Posted : July 30, 2010
Last Update Posted : December 29, 2010
Information provided by:
Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: colchicine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : December 2010
Actual Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: MDRD eGFR 10~50 ml/min/1.73m2 Drug: colchicine
colchicine 1T tid

Primary Outcome Measures :
  1. serum colchicine level [ Time Frame: 0,1,6 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173107

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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
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Responsible Party: Suhnggwon Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01173107    
Other Study ID Numbers: Colchicine_2010_1
First Posted: July 30, 2010    Key Record Dates
Last Update Posted: December 29, 2010
Last Verified: December 2010
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents