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Table 1 Subject inclusion and exclusion criteria of the Vienna RAP Study

From: Pulsed oral sirolimus in advanced autosomal-dominant polycystic kidney disease (Vienna RAP Study): study protocol for a randomized controlled trial

Inclusion criteria  
  • ADPKD, as confirmed by history, ultrasound, computed tomography or magnetic resonance imaging
  • 18 years of age, or older
  • Baseline eGFR (4-variable MDRD equation) below 60 mL/min per 1.73 m2
  • Negative serum pregnancy test prior to administration of sirolimus and agreement to use contraception throughout the study and for three months after
  • Written informed consent
Exclusion criteria  
  • Need for renal replacement therapy
  • Pregnancy or lactation
  • Plans to become pregnant in the near future
  • Refusal to use sufficient contraception
  • Proteinuria as defined as protein:creatinine ratio >1,000 or >1 g/d, respectively
  • History of life-threatening complications of ADPKD
  • Evidence of active systemic or localized major infection
  • Evidence of infiltrate or consolidation on chest X-ray
  • Use of any investigational drug or treatment up to four weeks prior to enrolment and during the study
  • Known allergy or hypersensitivity to sirolimus and its derivatives
  • Medication that will interfere with the CYP3A4/CYP3A5 system
  • Total white blood cell count below or equal to 3,000/mm3
  • Platelet count below or equal to 100,000/mm3
  • Fasting triglycerides above or equal to 400 mg/dL
  • Fasting total cholesterol above or equal to 300 mg/dL
  • Concomitant glomerular diseases
  • Psychiatric disorders and any condition that might prevent full comprehension of the purposes and risks of the study
  • History of malignancy, with the exception of adequately treated basal cell and squamous cell carcinoma of the skin
  • HIV positivity
  1. ADPKD, autosomal-dominant polycystic kidney disease; CYP, cytochrome p-450; eGFR, estimated glomerular filtration rate; HIV, human immunodeficiency virus; MDRD, modification of diet in renal disease.