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

Phase 4CompletedNCT02083991

Vastra Gotaland Region224 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

224

Conditions

Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 12 month after transplantation

Secondary Outcomes

Cumulative incidence of NODAT

Time frame: 3, 6, 24 month after transplantation

Composite measure

Freedom from acute rejection, graft and patient survival

Time frame: 12, 24 months

Renal function

Evaluated by measured glomerular filtration rate (mGFR)

Time frame: 12, 24 months

Incidence of acute rejection and chronic changes

Analysed by protocol biopsies, evaluated by the Banff system.

Time frame: 12 months

Incidence of hypertension

Standardized measurement.

Time frame: 3, 12, 24 months

Antihypertensive treatment

Number and type of antihypertensive drugs.

Time frame: 3, 12, 24 months

Lipid lowering drugs

Number and type of lipid lowering drugs.

Time frame: 12, 24 months

Incidence of antibody-mediated rejection

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

Time frame: 12, 24 months

Cumulative frequency of cardiovascular complications and events.

Collecting Adverse Events (AE) reports

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

Cumulative frequency of malignancy.

Collecting AE reports

Time frame: 6, 12, 24 months

Cumulative frequency of infections

Collecting AE reports

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes