Difference of 12-hour AUCNCT01780948
Pharmacokinetic of Everolimus and Atorvastatin Co-administration
A study testing Atorvastatin 20 mg and Everolimus in people with Difference of 12-hour AUC, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Hypothesis : In renal transplantation recipient who received immunosuppressive drug "certican" and have hypercholesterolemia will get lipid lower drug-HMG Co-A reductase inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difference of 12-hour AUC
- What is being tested?
- Atorvastatin 20 mg and Everolimus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post renal transplantation recipient who received immunosuppressive drug Everolimus and has hypercholesterolemia
- Co everolimus level within 3-12 ng/mL
- Informed consent
- Patient can follow research methodology
Who cannot join
- Patient don't want to participate in the study
- Post renal transplantation recipient who have normal lipid profile
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Interaction and Pharmacokinetic Assessment of Everolimus When Coadministered With Atorvastatin in Renal Transplantation Recipient
Hypothesis : In renal transplantation recipient who received immunosuppressive drug "certican" and have hypercholesterolemia will get lipid lower drug-HMG Co-A reductase inhibitors. Because atorvastatin and everolimus have metabolism via Cytochrome P450 subfamily 3A4 both, so investigator made the hypothesis that when patients received everolimus with atorvastatin will change area under the time concentration curve of everolimus.
Read the detailed description
Population : Thai postrenal transplantation recipient who received everolimus and have hypercholesterolemia in posttransplantation clinic at Faculty of Medicine, Chulalongkorn University.
Study Design : Experimental study, Two-sample crossover study Sample size calculation :N = 18 Primary outcome : 12-hour area under the time concentration curve of everolimus Secondary outcome : renal function (serum creatinine, creatinine clearance)
Method :
- Patients will random to everolimus or everolimus with atorvastatin 20 mg arm for 1 month.
- Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 hour
- After first blood sample, patients will received everolimus only for 1 month (wash out period)
- Patients will switch to another arm eg.patient who had received everolimus will switch to everolimus with atorvastatin 20 mg for 1 month
- Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 hour
- Everolimus level will analyse for 12-hour AUC of everolimus.
- Conditions
- Difference of 12-hour AUC
- Being tested
- Atorvastatin 20 mg, Everolimus
- Keywords
- Drug Interaction, Pharmacokinetics, Everolimus, Atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 20 mgDrug
Also called Lipitor 20 mg
Add atorvastatin 20 mg and compare 12-hour AUC of everolimus between Arm everolimus and everolimus with atorvastatin 20 mg
EverolimusDrug
Also called Everolimus alone
Administration only everolimus, no atorvastatin. Everolimus administration with adjusted dose to target C trough (C0)level between 3-12 ng/mL.
| Study group | Role | What they receive |
|---|---|---|
| everolimus | Placebo comparator | Everolimus administration with adjusted dose to target C trough (C0) level between 3-12 ng/mL Receives: Drug: Atorvastatin 20 mg |
| everolimus with atorvastatin 20 mg | Experimental | Co-administration of everolimus and atorvastatin. Everolimus administration with adjusted dose to target C trough (C0)level between 3-12 ng/mL.
Atorvastatin 20 mg/day (fixed dose) Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-hour area under the time concentration curve of everolimus
compare when taking only everolimus to coadministered with atorvastatin
Measured: 3 months
Secondary outcomes (4)
Renal function
Renal function : serum creatinine, 24 hour creatinine clearance 24 hour urine protein, Urinalysis Sample take at month 0,1,2,3
Measured: 3 months
Liver function test
Total protein, Albumin, total bilirubin, direct bilirubin, AST, ALT, Alkaline phosphatase at month 0,1,2,3
Measured: 3 month
Lipid profile
Total cholesterol, Triglyceride, HDL, LDL at month 0,1,2,3
Measured: 3 month
Rhabdomyolysis
Adverse drug reaction from atorvastatin by measured CPK at month 0,1,2,3
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Difference of 12-hour AUCStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Ratchadapiseksompotch Research Fund
- Responsible party
- Principal investigator, ANOCHA WANITCHANONT, Chulalongkorn University
- Investigators
- Anocha Wanitchanont, MD., Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780948
- Sponsor's protocol ID
- A7478
- Status last verified
- Feb 2013
- First submitted
- 29 Jan 2013
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kovarik JM, Hartmann S, Hubert M, Berthier S, Schneider W, Rosenkranz B, Rordorf C. Pharmacokinetic and pharmacodynamic assessments of HMG-CoA reductase inhibitors when coadministered with everolimus. J Clin Pharmacol. 2002 Feb;42(2):222-8. doi: 10.1177/00912700222011148.
PubMed 11831546
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Interaction and Pharmacokinetic Assessment of Everolimus When Coadministered With Atorvastatin in Renal Transplantation Recipient
- ClinicalTrials.gov ID
- NCT01780948
- Acronym / sponsor ID
- A7478
- Conditions
- Difference of 12-hour AUC
- Keywords
- Drug Interaction, Pharmacokinetics, Everolimus, Atorvastatin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Ratchadapiseksompotch Research Fund
- Study start
- Sep 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis : In renal transplantation recipient who received immunosuppressive drug "certican" and have hypercholesterolemia will get lipid lower drug-HMG Co-A reductase inhibitors. Because atorvastatin and everolimus have metabolism via Cytochrome P450 subfamily 3A4 both, so investigator made the hypothesis that when patients received everolimus with atorvastatin will change area under the time concentration curve of everolimus.
Detailed description
Population : Thai postrenal transplantation recipient who received everolimus and have hypercholesterolemia in posttransplantation clinic at Faculty of Medicine, Chulalongkorn University.
Study Design : Experimental study, Two-sample crossover study Sample size calculation :N = 18 Primary outcome : 12-hour area under the time concentration curve of everolimus Secondary outcome : renal function (serum creatinine, creatinine clearance)
Method :
- Patients will random to everolimus or everolimus with atorvastatin 20 mg arm for 1 month.
- Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 hour
- After first blood sample, patients will received everolimus only for 1 month (wash out period)
- Patients will switch to another arm eg.patient who had received everolimus will switch to everolimus with atorvastatin 20 mg for 1 month
- Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 hour
- Everolimus level will analyse for 12-hour AUC of everolimus.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| everolimus | Placebo comparator | Drug: Atorvastatin 20 mgEverolimus administration with adjusted dose to target C trough (C0) level between 3-12 ng/mL |
| everolimus with atorvastatin 20 mg | Experimental | Drug: EverolimusCo-administration of everolimus and atorvastatin. Everolimus administration with adjusted dose to target C trough (C0)level between 3-12 ng/mL. Atorvastatin 20 mg/day (fixed dose) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post renal transplantation recipient who received immunosuppressive drug Everolimus and has hypercholesterolemia
- Co everolimus level within 3-12 ng/mL
- Informed consent
- Patient can follow research methodology
Key exclusion criteria (2 listed)
- Patient don't want to participate in the study
- Post renal transplantation recipient who have normal lipid profile
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 20 mgAlso: Lipitor 20 mgAdd atorvastatin 20 mg and compare 12-hour AUC of everolimus between Arm everolimus and everolimus with atorvastatin 20 mg | Drug | everolimus |
| EverolimusAlso: Everolimus aloneAdministration only everolimus, no atorvastatin. Everolimus administration with adjusted dose to target C trough (C0)level between 3-12 ng/mL. | Drug | everolimus with atorvastatin 20 mg |
Primary outcome
12-hour area under the time concentration curve of everolimus
Time frame: 3 months
compare when taking only everolimus to coadministered with atorvastatin
4 secondary outcomes
Renal function
Time frame: 3 months
Liver function test
Time frame: 3 month
Lipid profile
Time frame: 3 month
Rhabdomyolysis
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
- Background: PubMed 11831546Kovarik JM, Hartmann S, Hubert M, Berthier S, Schneider W, Rosenkranz B, Rordorf C. Pharmacokinetic and pharmacodynamic assessments of HMG-CoA reductase inhibitors when coadministered with everolimus. J Clin Pharmacol. 2002 Feb;42(2):222-8. doi: 10.1177/00912700222011148.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anocha Wanitchanont, MD. principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin 20 mg and Everolimus in people with Difference of 12-hour AUC, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-hour area under the time concentration curve of everolimus (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01780948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2013.