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

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ClinicalTrials.gov Identifier: NCT02083991
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

Brief 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : January 2013
Actual Primary Completion Date : January 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT) [ Time Frame: 12 month after transplantation ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083991


Locations
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Sweden
Transplant Institute, Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Vastra Gotaland Region
Investigators
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Principal Investigator: Per Lindnér, MD Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden
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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02083991    
Other Study ID Numbers: 2012-000451-13
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021
Keywords provided by Vastra Gotaland Region:
NODAT
Renal transplantation
Corticosteroids avoidance
CNI minimization
Additional relevant MeSH terms:
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Prednisolone
Thymoglobulin
Basiliximab
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents