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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01173107
First received: July 28, 2010
Last updated: December 27, 2010
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Chronic Kidney Disease
Drug: colchicine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • serum colchicine level [ Time Frame: 0,1,6 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDRD eGFR 10~50 ml/min/1.73m2 Drug: colchicine
colchicine 1T tid

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01173107

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Suhnggwon Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01173107     History of Changes
Other Study ID Numbers: Colchicine_2010_1
Study First Received: July 28, 2010
Last Updated: December 27, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Colchicine
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014