Renal TransplantPhase 4NCT01758107
Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients
A Phase 4 study testing Withdraw cyclosporine in people with Renal Transplant, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and Calcineurin inhibitor withdrawal. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Renal Transplant
- What is being tested?
- Withdraw cyclosporine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2010to Oct 2015
- Phase
- Phase 4
- 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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Kidney transplant with Sirolimus plus Cyclosporine plus Prednisolone more than 1 year
Who cannot join
- history of acute rejection, or subclinical rejection
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Chulalongkorn University
Bangkok
Natavudh Townamchai, MD, +66894904222, ntownamchai@gmail.com
Natavudh Townamchai, MD
About this study
Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and Calcineurin inhibitor withdrawal.
Read the detailed description
Sirolimus with Cyclosporine minimization is the standard protocol for kidney transplantation in Chulalongkorn University. The investigators published the safety of this regimen in Transplantation Proceeding 2008; 40: 2206-8.
The investigators now further study in those patients who doing well with this regimen more than 1 year. The patients will be asked for kidney biopsy to evaluate and make sure they don't have subclinical rejection. The patients who don't have subclinical rejection will discontinue cyclosporine and continue with only sirolimus and prednisolone.
- Conditions
- Renal Transplant
- Being tested
- Withdraw cyclosporine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withdraw cyclosporineOther
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus with Prednisolone | Experimental | Sirolimus with Prednisolone, and withdraw cyclosporine Receives: Other: Withdraw cyclosporine |
| Sirolimus with Cyclosporine with Prednisolone | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
longterm glomerular filtration rate defined by eGFR CKD-EPI
Measured: 5 years
Secondary outcomes (1)
Acute rejection rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startAug 2010
- Primary completionAug 2013
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natavudh Townamchai, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758107
- Sponsor's protocol ID
- monorapa
- Status last verified
- Feb 2015
- First submitted
- 25 Dec 2012
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT01758107
- Acronym / sponsor ID
- monorapa
- Conditions
- Renal Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2015 (estimated)
- First posted
- 1 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.
Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and Calcineurin inhibitor withdrawal.
Detailed description
Sirolimus with Cyclosporine minimization is the standard protocol for kidney transplantation in Chulalongkorn University. The investigators published the safety of this regimen in Transplantation Proceeding 2008; 40: 2206-8.
The investigators now further study in those patients who doing well with this regimen more than 1 year. The patients will be asked for kidney biopsy to evaluate and make sure they don't have subclinical rejection. The patients who don't have subclinical rejection will discontinue cyclosporine and continue with only sirolimus and prednisolone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus with Prednisolone | Experimental | Other: Withdraw cyclosporineSirolimus with Prednisolone, and withdraw cyclosporine |
| Sirolimus with Cyclosporine with Prednisolone | No intervention | – |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Kidney transplant with Sirolimus plus Cyclosporine plus Prednisolone more than 1 year
Key exclusion criteria (1 listed)
- history of acute rejection, or subclinical rejection
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 |
|---|---|---|
| Withdraw cyclosporine | Other | Sirolimus with Prednisolone |
Primary outcome
longterm glomerular filtration rate defined by eGFR CKD-EPI
Time frame: 5 years
1 secondary outcome
Acute rejection rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Withdraw cyclosporine in people with Renal Transplant, 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 1 inclusion and 1 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 3 Feb 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Natavudh Townamchai, MD (+66894904222, ntownamchai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
longterm glomerular filtration rate defined by eGFR CKD-EPI (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 3 Feb 2015.