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Table 1 Objectives of the Calcineurin Inhibitor-Sparing (CIS) trial

From: The Calcineurin Inhibitor-Sparing (CIS) Trial - individualised calcineurin-inhibitor treatment by immunomonitoring in renal allograft recipients: protocol for a randomised controlled trial

Primary objective To evaluate a CsA-based immunosuppressive regimen monitored by residual NFAT-regulated gene expression concerning reduction in cardiovascular risk assessed by the change in pulse wave velocity from baseline to six-month follow-up, compared to a CsA-based regimen monitored by CsA trough levels in renal allograft recipients
Secondary efficacy objectives To evaluate, in treatment group:
  - a composite endpoint of biopsy-proven acute rejection (BPAR), graft loss, death and loss to follow-up at Month 6
  - Incidence of BPAR, graft loss, loss to follow-up or death at Month 6
  - S-creatinine and cystatin C at Month 6.
  - Renal allograft function (eGFR calculated by MDRD, Nankivell and Cockroft-Gault formulae) at Month 6
  - Evolution of renal function (S-creatinine) over time by slope analysis
  - Creatinine slope (1/serum creatinine versus time) including the treatment period between baseline and Month 6
Secondary safety objectives To evaluate, in treatment group:
  - Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
  - Incidence of AEs leading to discontinuation from the study
  - Incidence of major cardiovascular events (myocardial infarction, apoplexy, peripheral arterial occlusive disease)
  - Pulse wave velocity, aortic pulse pressure, aortic systolic pressure, aortic augmentation index, ejection duration, heart rate variability
  - Changes in blood pressure (central and peripheral pulse pressure, systolic and diastolic, mean arterial blood pressure)
  - Changes in antihypertensive medication (number of antihypertensives)
  - Changes in lipids (cholesterol, LDL-, HDL-cholesterol, triglyceride) and lipid-lowering drugs
  - Changes in glucose levels, HbA1c and antidiabetic therapy
  - Changes in cardiovascular risk (for example Framingham score)
  - Changes in CsA-induced side effects (for example hypertrichosis, gingival overgrowth)
  - Incidence and severity of infections
  - Incidence and severity of malignancies
  - Changes in the quality of life assessed by the ESRD SCL™ questionnaire and SF12 questionnaire
Exploratory objectives To explore the incidence of DSA in treatment group, and in relation to acute rejection, in a subset of patients at participating centres
  1. BPAR, biopsy-proven acute rejection; CsA, ciclosporin A; DSA, donor-specific antibody; eGFR, estimated glomerular filtration rate; ESRD, end-stage renal disease; HDL, high-density lipoprotein; LDL, low-density lipoprotein; MDRD, Modification of Diet in Renal Disease; SCL, symptom checklist; SF12, Short-Form 12.