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

NCT01173107 | Completed Phase 4

• 1 other identifier: Colchicine_2010_1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• serum colchicine level

  0,1,6 hours

Study Arms (1)

MDRD eGFR 10~50 ml/min/1.73m2

EXPERIMENTAL

Drug: colchicine

Interventions

colchicine DRUG

colchicine 1T tid

MDRD eGFR 10~50 ml/min/1.73m2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: July 30, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2010
• Last Updated: December 29, 2010

Record last verified: 2010-12

Locations

KR (1)