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

January 3, 2021 updated by: Vastra Gotaland Region

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 41345
        • Transplant Institute, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Steroid-free low TAC-arm

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.
Drug: Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon
Active Comparator: Standard low-TAC arm

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT)
Time Frame: 12 month after transplantation
12 month after transplantation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Investigators

  • Principal Investigator: Per Lindnér, MD, Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

January 3, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-000451-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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