Status:
COMPLETED
Drug Interaction Between Colchicine and Calcineurin Inhibitors in Renal Graft Recipients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Renal Replacement Therapies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Ciclosporin inhibits P-glycoprotein should increase colchicine bioavailability whereas tacrolimus should not influence colchicine disposition. This is a prospective, controlled, open labeled study pe...
Detailed Description
* Renal transplantation \>= one year * eGFR (MDRD) \> 30ml/min * hemoglobin \>= 11g/dl * treatment with tacrolimus or cyclosporine * no previous muscular disease * no drugs interfering with P-glycopro...
Eligibility Criteria
Inclusion
- Patients with renal graft since at least 1 year
- Patients treated with ciclosporin or tacrolimus
- Are at least 18 years old.
- Glomerular filtration rate above 30 ml / min calculated using the MDRD formula
- Among the 14 patients receiving ciclosporin:
- The genotype is not a criterion for inclusion
- Among the 14 patients with tacrolimus treatment:
- 7 genotype ABCB1 3435CC, 7 genotype ABCB1 3435TT
- Recent (1 month) residual concentration of tacrolimus between 5-10ng/ml
- Recent (1 month) residual concentration of ciclosporin between 100-200ng/ml
- For women : a negative pregnancy test (serum beta hCG)
- Realization of a medical examination.
- Informed consent and writing form.
Exclusion
- Abnormal transaminases (AST and ALT above the ULN Laboratory).
- Underlying Liver Disease (steatosis, cirrhosis, chronic hepatitis, the virus of hepatitis C or B).
- Previous history of muscle disease (drug related especially the statin type).
- Leukopenia (WBC \<3000/mm3).
- Hemoglobin \<11g/dl.
- Patient treated by erythropoetin (whatever its hemoglobin value).
- Abnormal CPK (greater than the ULN Laboratory).
- Prior intolerance to colchicine.
- Regular intake of the following medications associated with rhabdomyolyses: antipsychotics, cholesterol lowering agents (statins or fibrates), zidovudine, antidepressants (selective inhibitor of serotonin reuptake) and lithium.
- Patient (e) can not refrain from consuming grapefruit juice.
- Patient (e) taking a tea based on St John's wort.
- Taking drugs inducers of P-gp or CYP3A4 (rifabutin, rifampin, carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine, protease inhibitors, griseofulvin).
- Taking drugs inhibitors of P-gp or CYP3A4 (quinidine, macrolide antibiotics, azole antifungals, protease inhibitors, amiodarone, diltiazem, verapamil).
- Chronic diarrhea.
- ABCB1 Genotype 3435CT for patients in the tacrolimus group.
- Participation in another concurrent trial.
- Patient (e) exclusion period of another trial.
- Patient (e) having reached the maximum annual amount of compensation provided by law.
- No affiliation to French social security scheme or without CMU.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01160276
Start Date
May 1 2010
End Date
January 1 2012
Last Update
April 11 2013
Active Locations (1)
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1
Assistance publique - Hôpitaux de Paris : Bicêtre Hospital
Le Kremlin-Bicêtre, France, 94275