microRNA ProfilesNCT02091973
MicroRNA Expression in Everolimus-based Versus Tacrolimus-based Regimens in Kidney Transplantation
A study testing Everolimus and Tacrolimus in people with microRNA Profiles, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The calcineurin inhibitor drugs including cyclosporin and tacrolimus are well-known as nephrotoxicity. However, these drugs are essential for kidney transplant especially in high immunological risks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- microRNA Profiles
- What is being tested?
- Everolimus and Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2010to Dec 2015
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have given informed consent to participate in the study
- Actual eGFR > 20-25 ml/min/1.73 m2
Who cannot join
- Multi-organ transplantation
- Pregnancy
- ABO incompatible blood group
- Second, third, fouth kidney transplantation
- HIV positive, active or carrier in any infections
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Chulalongkorn University
Bangkok, 10330
Wiwat Chancharoenthana, MD, MSc, 6622564251 ext. 106, wiwatmd@hotmail.com
About this study
Official title: MicroRNA Expression in Everolimus-based Versus Tacrolimus-based Maintenance Immunosuppressive Regimens in Kidney Transplantation
The calcineurin inhibitor drugs including cyclosporin and tacrolimus are well-known as nephrotoxicity. However, these drugs are essential for kidney transplant especially in high immunological risks. To date, however, there is an alternative regimen by using of everolimus-based which showing less toxicity than tacrolimus-based regimen by its mechanisms. Of note, this study aims to evaluate the toxicity by using microRNA profiles detection between everolimus-based and tacrolimus-based immunosuppressive regimen in kidney transplantation.
Read the detailed description
The author aims to evaluate the effects of two regimens (everolimus-based versus tacrolimus-based) in kidney transplantation recipients. Both of regimens are prescribed only in recipents who have low immunologicla risks. After informed consent, all eligible recipients will be collected blood and urine sample for microRNA profile testing during study periods.
- Conditions
- microRNA Profiles
- Being tested
- Everolimus, Tacrolimus
- Keywords
- everolimus, tacrolimus, kidney transplantation, microRNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Everolimus dosing to target tough level 6-10 mg/ml
TacrolimusDrug
Tacrolimus dosing to target tough level 5-10 ng/ml
| Study group | Role | What they receive |
|---|---|---|
| Everolimus | Experimental | everolimus dosing to tough level 6-10 ng/ml Receives: Drug: Everolimus |
| Tacrolimus | Experimental | Tacrolimus dosing to target tough level 5-10 ng/ml Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
microRNA profiles
microRNA profiles including rejection and nephrotoxicity markers
Measured: 5 years
Secondary outcomes (1)
Allograft tissue pathology
Pathology studies including rejection, interstitial fibrosis and tubular atrophy
Measured: At year 2 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startJun 2010
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for microRNA ProfilesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wiwat Chancharoenthana, Chulalongkorn University
- Investigators
- Wiwat Chancharoenthana, MD, Msc., Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091973
- Sponsor's protocol ID
- WWC-004
- Status last verified
- Mar 2014
- First submitted
- 18 Mar 2014
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNA Expression in Everolimus-based Versus Tacrolimus-based Maintenance Immunosuppressive Regimens in Kidney Transplantation
- ClinicalTrials.gov ID
- NCT02091973
- Acronym / sponsor ID
- WWC-004
- Conditions
- microRNA Profiles
- Keywords
- everolimus, tacrolimus, kidney transplantation, microRNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 19 Mar 2014 (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.
The calcineurin inhibitor drugs including cyclosporin and tacrolimus are well-known as nephrotoxicity. However, these drugs are essential for kidney transplant especially in high immunological risks. To date, however, there is an alternative regimen by using of everolimus-based which showing less toxicity than tacrolimus-based regimen by its mechanisms. Of note, this study aims to evaluate the toxicity by using microRNA profiles detection between everolimus-based and tacrolimus-based immunosuppressive regimen in kidney transplantation.
Detailed description
The author aims to evaluate the effects of two regimens (everolimus-based versus tacrolimus-based) in kidney transplantation recipients. Both of regimens are prescribed only in recipents who have low immunologicla risks. After informed consent, all eligible recipients will be collected blood and urine sample for microRNA profile testing during study periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus | Experimental | Drug: Everolimuseverolimus dosing to tough level 6-10 ng/ml |
| Tacrolimus | Experimental | Drug: TacrolimusTacrolimus dosing to target tough level 5-10 ng/ml |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have given informed consent to participate in the study
- Actual eGFR > 20-25 ml/min/1.73 m2
Key exclusion criteria (5 listed)
- Multi-organ transplantation
- Pregnancy
- ABO incompatible blood group
- Second, third, fouth kidney transplantation
- HIV positive, active or carrier in any infections
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 |
|---|---|---|
| EverolimusEverolimus dosing to target tough level 6-10 mg/ml | Drug | Everolimus |
| TacrolimusTacrolimus dosing to target tough level 5-10 ng/ml | Drug | Tacrolimus |
Primary outcome
microRNA profiles
Time frame: 5 years
microRNA profiles including rejection and nephrotoxicity markers
1 secondary outcome
Allograft tissue pathology
Time frame: At year 2 and 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
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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.
Wiwat Chancharoenthana, MD, Msc. 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 Everolimus and Tacrolimus in people with microRNA Profiles, 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Mar 2014. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wiwat Chancharoenthana, MD, MSc. (6622564251 ext. 101, wiwatmd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microRNA profiles (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2014.