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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Colchicine

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