Diabetes MellitusPhase 4SAILORNCT02083991
Trial of Steroid Avoidance and Low-dose CNI by ATG-induction in Renal Transplantation
A Phase 4 study testing Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon in people with Diabetes Mellitus, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Balancing immunosuppressive treatment in organ transplantation in order to achieve effective prevention of rejection on one side and avoidance of negative side effects on the other side is a major challenge, leading to developing different immunosuppressive protocols. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2013to Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First or second single kidney (cadaveric or living donors) transplant recipients.
- Considered for a standard immunosuppressive protocol.
- Must be capable of giving written informed connect for participation in the study for 24 months.
Who cannot join
- Diabetes mellitus or plasma glucose >11,1 at admission.
- Receiving steroids at the time of transplantation or likely to need steroids after transplantation.
- Multiorgan transplants and/or previously transplanted with any other organ than kidney.
- Panel reacting antibodies(PRA) >25% in most recent test or considered to be of high risk for rejection which requires an enhanced immunosuppression.
- Renal transplants from HLA-identical sibling.
- Hypersensitivity to, or disability to take immunosuppressive drugs.
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- Blood group(ABO)-incompatible transplants.
- Unlikely to comply with the study requirements.
- Transplant from donor positive for HIV, HBsAg, Hepatitis C.
- Female of childbearing potential planing/being pregnant or unwilling to use contraception.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Transplant Institute, Sahlgrenska University Hospital
Gothenburg, 41345
About this study
Official title: A Controlled Randomized, Open-label, Multi-centre Study Evaluating if a Steroid-free Immunosuppressive Protocol, Based ATG-induction, Low Tacrolimus-dose and Therapeutic Drug Monitoring of Mycophenolate Mofetil, Reduces the Incidence of New Onset Diabetes After Transplantations, in Comparison With Standard Steroid-based Protocol With Low-dose Tacrolimus.
Balancing immunosuppressive treatment in organ transplantation in order to achieve effective prevention of rejection on one side and avoidance of negative side effects on the other side is a major challenge, leading to developing different immunosuppressive protocols. Cornerstones of immunosuppressive treatment such as Corticosteroids (CS) and Calcineurin Inhibitors (CNI) are known to cause an increased incidence of diabetes, cardiovascular morbidity, nephrotoxicity and malignancies.
The investigators believe that both avoidance of CS and minimization of CNI, while using Anti-ThymocyteGlobuline(ATG) induction (instead of interleucin-2 receptor blockers) and mycofenolate mofetil(MMF) therapeutic drug monitoring is going to reduce negative side effects, without increased rejection frequency in renal transplanted patients.
- Conditions
- Diabetes Mellitus
- Being tested
- Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon
- Keywords
- NODAT, Renal transplantation, Corticosteroids avoidance, CNI minimization
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolonDrug
| Study group | Role | What they receive |
|---|---|---|
| Steroid-free low TAC-arm | Experimental | Induction therapy: Thymoglobulin i.v. 2,5 mg/kg day 0 and 1, preceded by methylprednisolone i.v. 250 mg day 0 and 50 mg day 1.
Maintenance therapy: Advagraf(TAC) 0,2 mg/kg p.o. started day1 (target concentration 5-10 ng/ml, after 3 months 4-7 ng/ml; MMF 1g x 2 p.o. (target Area Under Curve, AUC 40-60 mg.h/L); No steroids p.o. Receives: Drug: Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon |
| Standard low-TAC arm | Active comparator | Induction therapy: Simulect i.v. 20 mg day 0 and 4; Steroids i.v. according to local practice.
Maintenance therapy: Advagraf(TAC) p.o. 0,2 mg/(target concentration 5-10 ng/ml, after 3 months 4-7 ng/ml); MMF 1g x 2 p.o. (target AUC 40-60 mg.h/L); Steroids p.o. according to hospital practice (but not less than 5mg daily after 6 months). Receives: Drug: Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT)
Measured: 12 month after transplantation
Secondary outcomes (11)
Cumulative incidence of NODAT
Measured: 3, 6, 24 month after transplantation
Composite measure
Freedom from acute rejection, graft and patient survival
Measured: 12, 24 months
Renal function
Evaluated by measured glomerular filtration rate (mGFR)
Measured: 12, 24 months
Incidence of acute rejection and chronic changes
Analysed by protocol biopsies, evaluated by the Banff system.
Measured: 12 months
Incidence of hypertension
Standardized measurement.
Measured: 3, 12, 24 months
Antihypertensive treatment
Number and type of antihypertensive drugs.
Measured: 3, 12, 24 months
Lipid lowering drugs
Number and type of lipid lowering drugs.
Measured: 12, 24 months
Incidence of antibody-mediated rejection
Analysed by biopsies, evaluated by the Banff system, and by donor-specific HLA antibodies
Measured: 12, 24 months
Cumulative frequency of cardiovascular complications and events.
Collecting Adverse Events (AE) reports
Measured: 10 days, 3, 12, 24 months
Cumulative frequency of malignancy.
Collecting AE reports
Measured: 6, 12, 24 months
Cumulative frequency of infections
Collecting AE reports
Measured: 10 days, 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Per Lindnér, MD, Principal investigator, Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083991
- Sponsor's protocol ID
- 2012-000451-13
- Acronym
- SAILOR
- Status last verified
- Jan 2021
- First submitted
- 3 Mar 2014
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Randomized, Open-label, Multi-centre Study Evaluating if a Steroid-free Immunosuppressive Protocol, Based ATG-induction, Low Tacrolimus-dose and Therapeutic Drug Monitoring of Mycophenolate Mofetil, Reduces the Incidence of New Onset Diabetes After Transplantations, in Comparison With Standard Steroid-based Protocol With Low-dose Tacrolimus.
- ClinicalTrials.gov ID
- NCT02083991
- Acronym / sponsor ID
- SAILOR / 2012-000451-13
- Conditions
- Diabetes Mellitus
- Keywords
- NODAT, Renal transplantation, Corticosteroids avoidance, CNI minimization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Jan 2013 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 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.
Balancing immunosuppressive treatment in organ transplantation in order to achieve effective prevention of rejection on one side and avoidance of negative side effects on the other side is a major challenge, leading to developing different immunosuppressive protocols. Cornerstones of immunosuppressive treatment such as Corticosteroids (CS) and Calcineurin Inhibitors (CNI) are known to cause an increased incidence of diabetes, cardiovascular morbidity, nephrotoxicity and malignancies.
The investigators believe that both avoidance of CS and minimization of CNI, while using Anti-ThymocyteGlobuline(ATG) induction (instead of interleucin-2 receptor blockers) and mycofenolate mofetil(MMF) therapeutic drug monitoring is going to reduce negative side effects, without increased rejection frequency in renal transplanted patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid-free low TAC-arm | Experimental | Drug: Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolonInduction therapy: Thymoglobulin i.v. 2,5 mg/kg day 0 and 1, preceded by methylprednisolone i.v. 250 mg day 0 and 50 mg day 1. Maintenance therapy: Advagraf(TAC) 0,2 mg/kg p.o. started day1 (target concentration 5-10 ng/ml, after 3 months 4-7 ng/ml; MMF 1g x 2 p.o. (target Area Under Curve, AUC 40-60 mg.h/L); No steroids p.o. |
| Standard low-TAC arm | Active comparator | Drug: Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolonInduction therapy: Simulect i.v. 20 mg day 0 and 4; Steroids i.v. according to local practice. Maintenance therapy: Advagraf(TAC) p.o. 0,2 mg/(target concentration 5-10 ng/ml, after 3 months 4-7 ng/ml); MMF 1g x 2 p.o. (target AUC 40-60 mg.h/L); Steroids p.o. according to hospital practice (but not less than 5mg daily after 6 months). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First or second single kidney (cadaveric or living donors) transplant recipients.
- Considered for a standard immunosuppressive protocol.
- Must be capable of giving written informed connect for participation in the study for 24 months.
Key exclusion criteria (10 listed)
- Diabetes mellitus or plasma glucose >11,1 at admission.
- Receiving steroids at the time of transplantation or likely to need steroids after transplantation.
- Multiorgan transplants and/or previously transplanted with any other organ than kidney.
- Panel reacting antibodies(PRA) >25% in most recent test or considered to be of high risk for rejection which requires an enhanced immunosuppression.
- Renal transplants from HLA-identical sibling.
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 |
|---|---|---|
| Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon | Drug | Standard low-TAC arm, Steroid-free low TAC-arm |
Primary outcome
Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT)
Time frame: 12 month after transplantation
11 secondary outcomes
Cumulative incidence of NODAT
Time frame: 3, 6, 24 month after transplantation
Composite measure
Time frame: 12, 24 months
Renal function
Time frame: 12, 24 months
Incidence of acute rejection and chronic changes
Time frame: 12 months
Incidence of hypertension
Time frame: 3, 12, 24 months
Antihypertensive treatment
Time frame: 3, 12, 24 months
Lipid lowering drugs
Time frame: 12, 24 months
Incidence of antibody-mediated rejection
Time frame: 12, 24 months
Cumulative frequency of cardiovascular complications and events.
Time frame: 10 days, 3, 12, 24 months
Cumulative frequency of malignancy.
Time frame: 6, 12, 24 months
Cumulative frequency of infections
Time frame: 10 days, 3, 6, 12, 24 months
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 5 Jan 2021.
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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.
Per Lindnér, MD principal investigator
Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden
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 Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon in people with Diabetes Mellitus, run by Vastra Gotaland Region at 1 site in Sweden.
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 3 inclusion and 10 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 5 Jan 2021. 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 Sweden. 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?
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?
Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT) (time frame: 12 month after transplantation). 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 5 Jan 2021.