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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease

Treatments: Drug: colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT01173107

Colchicine_2010_1

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

MDRD eGFR 10~50 ml/min/1.73m2

Experimental group

Treatment:

Drug: colchicine