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Table 2 Study exclusion criteria

From: Clinical proof-of-concept trial to assess the therapeutic effect of sirolimus in patients with autosomal dominant polycystic kidney disease: SUISSE ADPKD study

• Female patient of childbearing potential who is unwilling to use effective means of contraception
• Increased liver enzymes (2-fold above normal values)
• Hypercholesterolemia (fasting cholesterol > 8 mmol/l) or hypertriglyceridaemia (> 5 mmol/l) not controlled by lipid lowering therapy
• Granulocytopenia (white blood cell < 3,000/mm3) or thrombocytopenia (platelets < 100,000/mm3)
• Infection with hepatitis B or C, HIV
• History of malignancy
• Mental illness that interferes with the patient ability to comply with the protocol
• Drug or alcohol abuse within one year of baseline
• Co-medication with strong inhibitor of CYP3A4 and or P-gp like voriconazole, ketoconazole, diltiazem, verapamil, erythromycin or with a strong CYP3A4 and or P-gp inductor like rifampicin
• Known hypersensitivity to macrolides or Rapamune®
• Patients who are unwilling or unable to give informed consent