Trial of Steroid Avoidance and Low-dose CNI by ATG-induction in Renal Transplantation

Diabetes Mellitus Clinical Trial

— SAILOR  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083991
• Other study ID #: 2012-000451-13
• Status: Completed
• Phase: Phase 4
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: January 2021
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: December 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon

Locations

Country	Name	City	State
Sweden	Transplant Institute, Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT)		12 month after transplantation
Secondary	Cumulative incidence of NODAT		3, 6, 24 month after transplantation
Secondary	Composite measure	Freedom from acute rejection, graft and patient survival	12, 24 months
Secondary	Renal function	Evaluated by measured glomerular filtration rate (mGFR)	12, 24 months
Secondary	Incidence of acute rejection and chronic changes	Analysed by protocol biopsies, evaluated by the Banff system.	12 months
Secondary	Incidence of hypertension	Standardized measurement.	3, 12, 24 months
Secondary	Antihypertensive treatment	Number and type of antihypertensive drugs.	3, 12, 24 months
Secondary	Lipid lowering drugs	Number and type of lipid lowering drugs.	12, 24 months
Secondary	Incidence of antibody-mediated rejection	Analysed by biopsies, evaluated by the Banff system, and by donor-specific HLA antibodies	12, 24 months
Secondary	Cumulative frequency of cardiovascular complications and events.	Collecting Adverse Events (AE) reports	10 days, 3, 12, 24 months
Secondary	Cumulative frequency of malignancy.	Collecting AE reports	6, 12, 24 months
Secondary	Cumulative frequency of infections	Collecting AE reports	10 days, 3, 6, 12, 24 months