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OpenTrials
Completed

NCT Number: NCT01173107

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine

Drug

colchicine 1T tid

Primary outcomes

  1. serum colchicine level

    Time frame: 0,1,6 hours

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
First posted
Jul 30, 2010
Registry last updated
Dec 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.