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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease

Intervention: colchicine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Seoul National University Hospital

Summary

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

Clinical Details

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: serum colchicine level

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Seoul National University Hospital, Seoul, Korea, Republic of
Additional Information

Starting date: December 2010
Last updated: December 27, 2010

Page last updated: August 20, 2015

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