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Table 3 Key inclusion and exclusion criteria for 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

Key inclusion criteria Key exclusion criteria
- Male or female patients ≥18 years old. - Patients with a history of acute rejection classified > BANFF II, chronic active antibody-mediated rejection or chronic T-cell-mediated rejection.
- Recipients of deceased or living kidney transplants. - Patients with an EC-MPS dose of <720 mg/d (MMF <1000 mg/d) and MPA-AUC <30 mg*h/L.
- Time after the last renal transplantation at least six months. - Patients with symptoms of significant somatic or mental illness. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent.
- Stable renal allograft function, defined as S-creatinine ≤3.5 mg/dL and Δ S-creatinine ≤30% during the last three months. - Females of childbearing potential who are planning to become pregnant, who are pregnant or lactating, and/or who are unwilling to use effective means of contraception, unless
- Patients who are willing and able to participate in the study and from whom written informed consent has been obtained. a. their career, lifestyle, or sexual orientation precludes intercourse with a male partner,
or
b. their partners have been sterilised by vasectomy or other means
  - Evidence of drug or alcohol abuse
  - Patients actively taking part in an interventional trial
  1. AUC, area under the curve; EC-MPS, enteric-coated mycophenolate sodium; MMF, mycophenolate mofetil; MPA, mycophenolic acid.