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Completed

NCT Number: NCT02083991

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Transplant Institute, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Primary outcomes

  1. Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT)

    Time frame: 12 month after transplantation

Secondary outcomes

  1. Cumulative incidence of NODAT

    Time frame: 3, 6, 24 month after transplantation

  2. Composite measure

    Time frame: 12, 24 months

    Freedom from acute rejection, graft and patient survival

  3. Renal function

    Time frame: 12, 24 months

    Evaluated by measured glomerular filtration rate (mGFR)

  4. Incidence of acute rejection and chronic changes

    Time frame: 12 months

    Analysed by protocol biopsies, evaluated by the Banff system.

  5. Incidence of hypertension

    Time frame: 3, 12, 24 months

    Standardized measurement.

  6. Antihypertensive treatment

    Time frame: 3, 12, 24 months

    Number and type of antihypertensive drugs.

  7. Lipid lowering drugs

    Time frame: 12, 24 months

    Number and type of lipid lowering drugs.

  8. Incidence of antibody-mediated rejection

    Time frame: 12, 24 months

    Analysed by biopsies, evaluated by the Banff system, and by donor-specific HLA antibodies

  9. Cumulative frequency of cardiovascular complications and events.

    Time frame: 10 days, 3, 12, 24 months

    Collecting Adverse Events (AE) reports

  10. Cumulative frequency of malignancy.

    Time frame: 6, 12, 24 months

    Collecting AE reports

  11. Cumulative frequency of infections

    Time frame: 10 days, 3, 6, 12, 24 months

    Collecting AE reports

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study 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.

Acronym: SAILOR

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 11, 2014
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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