DiabetesNODATNCT02095418
Comparison of New-onset Diabetes After Transplantation Between Two Steroid Withdrawal Group With CellCept
A study testing Mycophenolate mofetil, Corticosteroids and Corticosteroids, Mycophenolate mofetil in people with Diabetes, run by Samsung Medical Center at 5 sites in South Korea.
Trial summary
With improvements in patient and graft survival, increasing attention has been placed on complications that contribute to long-term patient morbidity and mortality. New-onset diabetes after transplantation (NODAT) is a common complication of solid-organ transplantation, and is a strong predictor of graft failure and… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Mycophenolate mofetil, Corticosteroids and Corticosteroids, Mycophenolate mofetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Feb 2014to Feb 2018
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Male or female patients between 20-70 years 2.De novo patients 3.Recipients from living or cadaveric donors 4.Single organ recipient (liver only) 5.White Blood Cell(WBC) ≥ 3,000uL 6.Women of childbearing potential had to have a negative serum or urine pregnancy test within 1 week prior to beginning study treatment. Effective contraception has to be used before beginning therapy, during therapy and for 6 weeks following discontinuation of therapy 7.Patients co-operative and able to complete all the assessment procedures. 8.Patients provided written informed consent
Who cannot join
- Patients who receive immunosuppressive therapy (except steroid treatment) within the preceding 28 days.
- Incompatible A,B, and O blood group system.
- Active infection
- Patients whose laboratory results reveal severe anaemia (as defined by a haemoglobin value < 9 g/dL for adults receiving erythropoietin, 6.5 g/dL for adults not receiving erythropoietin, leukopenia (as defined by a white blood cell [WBC] value of <1500/mm3) or thrombocytopenia (as defined by a platelet count of <30,000/mm3).
- Mandatory intake of prohibited drugs or if it is probable that the patient would require treatment with such drugs after transplant
- Patient is allergic or intolerant to excipients, steroids, Mycophenolate mofetil(MMF), tacrolimus or basiliximab.
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- Patients with any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication with the investigator or with study procedures.
- The receipt of a new investigational drug within the previous 3 months
- Pregnant or lactating females.
- Women of child-bearing potential not willing to use a reliable form of contraception.
- Previous organ transplantation
- Patients who have diabetes mellitus prior to transplantation
- Patients who have cancer other than liver cancer
- Patients who have HGPRT(hypoxanthine quinine phosphoribosyl transferase) deficiency, Lesch-Nyhan syndrome, Kelly-Seegmiller syndrome
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Not yet recruiting
Daegu Catholic University Medical Center
Daegu
Dongrak Choi, M.D., Ph.D., 82-10-9041-0742, dnchoi@cu.ac.kr
- Recruiting
Samsung Medical Center
Seoul, 135-710
Jae Won Joh, M.D., Ph.D., 82 2 1599 3114, jw.joh@Samsung.com
- Not yet recruiting
National Cancer Center
Seoul
Seoung Hoon Kim, M.D., Ph.D., 82-10-2907-3766, kshlj@hanmail.net
- Not yet recruiting
Seoul National University
Seoul
Kwang-Woong Lee, M.D., Ph.D., 82-2-2072-2511, kwleegs@gmail.com
- Not yet recruiting
Ajou University Hospital
Suwon
Hee-Jung Wang, M.D., Ph.D., 82-31-219-5204, wanghj@ajou.ac.kr
About this study
Official title: Open Label, Multicenter Randomized Control Study to Investigate the Incidence of NODAT (New-Onset Diabetes After Transplantation), Safety and Efficacy of Corticosteroids Early Withdrawal in Liver Transplanted Recipients
With improvements in patient and graft survival, increasing attention has been placed on complications that contribute to long-term patient morbidity and mortality. New-onset diabetes after transplantation (NODAT) is a common complication of solid-organ transplantation, and is a strong predictor of graft failure and cardiovascular mortality in the transplant population. Risk factors for NODAT in transplant recipients are similar to those in non-transplant patients, but transplant-specific risk factors such as hepatitis C (HCV) infection, corticosteroids and calcineurin inhibitors play a dominant role in NODAT pathogenesis. The predominant factor for causing NODAT by corticosteroids seems to be the aggravation of insulin resistance; however several studies have displayed deleterious effects on insulin secretion and β-cells. Thus, adjusting the immunosuppressant regimen to improve glucose tolerance must be measured and defined from long term perspective.
As recipients of organ transplants survive longer, the complications of NODAT have assumed greater importance; therefore, we designed a prospective study to compare the safety and efficacy of early versus late withdrawal of corticosteroids after liver transplantation.
- Conditions
- Diabetes
- Being tested
- Mycophenolate mofetil, Corticosteroids, Corticosteroids, Mycophenolate mofetil
- Keywords
- New-onset diabetes after transplantation (NODAT), Liver transplantation
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate mofetil, CorticosteroidsDrug
Also called CellCept, Methylon
tacrolimus (low dose, trough level of 5-12ng/ml)+Mycophenolate mofetil(500-1500mg/day*, bid)+ Basiliximab + corticosteroids 500mg to 5mg or above (2 weeks)
Corticosteroids, Mycophenolate mofetilDrug
Also called Methylon, CellCept
tacrolimus (low dose, trough level of 5-12ng/ml)+Mycophenolate mofetil(500-1000mg/day*, bid)+ Basiliximab + corticosteroids 500mg to 5mg or above (3 month±2weeks)
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate mofetil, Corticosteroids | Experimental | * Mycophenolate mofetil: 500-1500mg/day, bid, PO
* Corticosteroids: 500mg for the first dosage. It will be tapered at least 5mg for 14days and withdrawn Receives: Drug: Corticosteroids, Mycophenolate mofetil |
| Corticosteroids, Mycophenolate mofetil | Active comparator | * Mycophenolate mofetil: 500-1000mg/day, bid, PO
* Corticosteroids 500mg for the first dosage. It will be tapered at least 5mg for 3months(± 2 weeks) and withdrawn. Receives: Drug: Mycophenolate mofetil, Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate incidence of NODAT in patients of two arms
NODAT will be defined as consecutively FPG ≥126mg/dl in two different days or PPG 2hr ≥200mg/dl Ref. Steroid Withdrawal in Adult Liver Transplantation: Occurrence at a Single Center. Transplantation Proceedings, 2010; 42: 4132-4136)
- Incidence of NODAT in ref. : (9.9%)
- 95% Confidence Interval(CI): (6%)
Considering 10% drop-out rate, 76 patients will be enrolled in one arm. Totally, 152 will be enrolled.
Measured: for 1 year
Secondary outcomes (5)
To evaluate incidence rate of first acute rejection
Measured: for 1 year
To evaluate time to first acute rejection
Measured: for 1 year
To evaluate proportion of patients experiencing treatment failure
Measured: for 1 year
To evaluate graft survival rates
Measured: for 1 year
To evaluate patient overall survial, OS
Measured: for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAE WON JOH, Samsung Medical Center
- Investigators
- Jae Won Joh, M.D., Ph.D., Principal investigator, Samsung Medical CenterKwang-Woong Lee, M.D., Ph.D., Principal investigator, Seoul National University HospitalSeoung Hoon Kim, M.D., Ph.D., Principal investigator, National Cancer CenterHee-Jung Wang, M.D., Ph.D., Principal investigator, Ajou University School of MedicineDongrak Choi, M.D., Ph.D., Principal investigator, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095418
- Sponsor's protocol ID
- ML28170
- Acronym
- NODAT
- Status last verified
- Mar 2014
- First submitted
- 14 Mar 2014
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multicenter Randomized Control Study to Investigate the Incidence of NODAT (New-Onset Diabetes After Transplantation), Safety and Efficacy of Corticosteroids Early Withdrawal in Liver Transplanted Recipients
- ClinicalTrials.gov ID
- NCT02095418
- Acronym / sponsor ID
- NODAT / ML28170
- Conditions
- Diabetes
- Keywords
- New-onset diabetes after transplantation (NODAT), Liver transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 24 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.
With improvements in patient and graft survival, increasing attention has been placed on complications that contribute to long-term patient morbidity and mortality. New-onset diabetes after transplantation (NODAT) is a common complication of solid-organ transplantation, and is a strong predictor of graft failure and cardiovascular mortality in the transplant population. Risk factors for NODAT in transplant recipients are similar to those in non-transplant patients, but transplant-specific risk factors such as hepatitis C (HCV) infection, corticosteroids and calcineurin inhibitors play a dominant role in NODAT pathogenesis. The predominant factor for causing NODAT by corticosteroids seems to be the aggravation of insulin resistance; however several studies have displayed deleterious effects on insulin secretion and β-cells. Thus, adjusting the immunosuppressant regimen to improve glucose tolerance must be measured and defined from long term perspective.
As recipients of organ transplants survive longer, the complications of NODAT have assumed greater importance; therefore, we designed a prospective study to compare the safety and efficacy of early versus late withdrawal of corticosteroids after liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate mofetil, Corticosteroids | Experimental | Drug: Corticosteroids, Mycophenolate mofetil* Mycophenolate mofetil: 500-1500mg/day, bid, PO * Corticosteroids: 500mg for the first dosage. It will be tapered at least 5mg for 14days and withdrawn |
| Corticosteroids, Mycophenolate mofetil | Active comparator | Drug: Mycophenolate mofetil, Corticosteroids* Mycophenolate mofetil: 500-1000mg/day, bid, PO * Corticosteroids 500mg for the first dosage. It will be tapered at least 5mg for 3months(± 2 weeks) and withdrawn. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Male or female patients between 20-70 years 2.De novo patients 3.Recipients from living or cadaveric donors 4.Single organ recipient (liver only) 5.White Blood Cell(WBC) ≥ 3,000uL 6.Women of childbearing potential had to have a negative serum or urine pregnancy test within 1 week prior to beginning study treatment. Effective contraception has to be used before beginning therapy, during therapy and for 6 weeks following discontinuation of therapy 7.Patients co-operative and able to complete all the assessment procedures. 8.Patients provided written informed consent
Key exclusion criteria (14 listed)
- Patients who receive immunosuppressive therapy (except steroid treatment) within the preceding 28 days.
- Incompatible A,B, and O blood group system.
- Active infection
- Patients whose laboratory results reveal severe anaemia (as defined by a haemoglobin value < 9 g/dL for adults receiving erythropoietin, 6.5 g/dL for adults not receiving erythropoietin, leukopenia (as defined by a white blood cell [WBC] value of <1500/mm3) or thrombocytopenia (as defined by a platelet count of <30,000/mm3).
- Mandatory intake of prohibited drugs or if it is probable that the patient would require treatment with such drugs after transplant
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 |
|---|---|---|
| Mycophenolate mofetil, CorticosteroidsAlso: CellCept, Methylontacrolimus (low dose, trough level of 5-12ng/ml)+Mycophenolate mofetil(500-1500mg/day*, bid)+ Basiliximab + corticosteroids 500mg to 5mg or above (2 weeks) | Drug | Corticosteroids, Mycophenolate mofetil |
| Corticosteroids, Mycophenolate mofetilAlso: Methylon, CellCepttacrolimus (low dose, trough level of 5-12ng/ml)+Mycophenolate mofetil(500-1000mg/day*, bid)+ Basiliximab + corticosteroids 500mg to 5mg or above (3 month±2weeks) | Drug | Mycophenolate mofetil, Corticosteroids |
Primary outcome
To evaluate incidence of NODAT in patients of two arms
Time frame: for 1 year
NODAT will be defined as consecutively FPG ≥126mg/dl in two different days or PPG 2hr ≥200mg/dl Ref. Steroid Withdrawal in Adult Liver Transplantation: Occurrence at a Single Center. Transplantation Proceedings, 2010; 42: 4132-4136) 1. Incidence of NODAT in ref. : (9.9%) 2. 95% Confidence Interval(CI): (6%) Considering 10% drop-out rate, 76 patients will be enrolled in one arm. Totally, 152 will be enrolled.
5 secondary outcomes
To evaluate incidence rate of first acute rejection
Time frame: for 1 year
To evaluate time to first acute rejection
Time frame: for 1 year
To evaluate proportion of patients experiencing treatment failure
Time frame: for 1 year
To evaluate graft survival rates
Time frame: for 1 year
To evaluate patient overall survial, OS
Time frame: for 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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.
Jae Won Joh, M.D., Ph.D. principal investigator
Samsung Medical Center
Kwang-Woong Lee, M.D., Ph.D. principal investigator
Seoul National University Hospital
Seoung Hoon Kim, M.D., Ph.D. principal investigator
National Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mycophenolate mofetil, Corticosteroids and Corticosteroids, Mycophenolate mofetil in people with Diabetes, run by Samsung Medical Center at 5 sites in South Korea.
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 14 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 24 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 5 sites in South Korea. 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 Jae Won Joh, M.D., Ph.D. (82215993114, jw.joh@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate incidence of NODAT in patients of two arms (time frame: for 1 year). 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 24 Mar 2014.