what is the correct dosage of colchicine in gouty patient who had renal impairment and received medication of dyslipidemia combination in prophylaxis goty flare? colchicine, gout, renal impairment, dosage, pharmacokinetic
Conditions
Interventions
colchicine was described in each depent on renal impairment and many recommendation had vary. However, the study was followed by Terkeltaub RA. Therefore, some participants did not receive correctd i
Treatment
colchicine dosage that was described by clinicians in patients who had vary degree of renal impairment
Sponsors
Naresuan university
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.both sex age>20 2.eGFR change not more than 25% by Cockcroft-Gault Equation at least 1 month from inform consent 3. diagnosis in primary gout and receive colchicine for goty flare prophylaxis at least 3 month 4. if patients receive dyslipidemia medication (example in atorvastatin , simvastatin) , these medications must stable dosage at least 3 month 5. if patients who received incorrect dosage of colchicine were included in the study and finish in the protocol , the patients were adjusted correctly dosage of colchicine that was adjusted by eGFR. These patients can be included in the trail again, if they finish last protocol at least 4 months after last adjusted correctly dosage of colchicine.
Exclusion criteria
Exclusion criteria: 1. colchicine or component of colchicine allergy 2. the cabnormal of AST, ALT imore than 2 time from normal limit in last atleast 3 months 3. received medication including Strong or moderate cytochrome P450 3A4 inhibitors - Cobicistat - Itraconazole - Ketoconazole - Voriconazole - Clarithromycin - Ciprofloxacin - Erythromycin - Fluconazole - Cimetidine - Verapamil - Diltiazem - Cyclosporine AND P-glycoprotein inhibitors - Amiodarone - Carvedilol - Quinidine - Clarithromycin - Itraconazole - Ranolazine - Verapamil within 14 day before including in the study 4. blood loss or donate blood component more than 300 cc. within 1 month before including in the study 5. gouty patients with HIV positive or cirrhosis or organ transplant or cancer were excluded 6. pregnancy test positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dosage of colchicine after stable dosage of colchicine at least 3 month in the screening date and plasma concentration before and after 2 hour in the includsion date Plasma concentration,recommendation of colchicine dosage in gouty patients who had renal impairment after stable dosage of colchicine at least 3 month in the screening date and plasma concentration before and after 2 hour in the includsion date population pharmacokinetics model,factor associated for colchicine level after stable dosage of colchicine at least 3 month in the screening date and plasma concentration before and after 2 hour in the includsion date population pharmacokinetic model | — |
Secondary
| Measure | Time frame |
|---|---|
| pattern of colchicine dosage in patients who had renal impairment after stable dosage of colchicine at least 3 month in the screening date percent ratio,activate PBMC in cochicine multiple level in WBC after stable dosage of colchicine at least 3 month in the screening date and plasma concentration before and after 2 hour in the includsion date stimulate by cystral and inflammasome response | — |
Countries
Thailand
Contacts
Public ContactPatapong Towiwat
Naresuan university
Outcome results
None listed