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Table 2 Trial sequence 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

Timeline E W1 W2 M1 M6 M12 M18 M24
Visit V1 V2 V3 V4 V5 V6 V7 V7
General         
Demography        
Clinical check    
Chemistry         
Sodium   
Potassium   
Calcium   
Phosphate   
Creatinine
Urea   
ASAT   
ALAT   
γ-GT   
Lipids   
Hba1c   
Glucose   
Pregnancy test   
Sirolimus trough levela  
Hematology         
Hemoglobin   
Leucocytes
Platelets
Urine         
24 hour proteinuria    
Creatinine clearance    
Protein/creatinine ratio
Albumin/creatinine ratio
Immunology         
HBV        
HCV        
HIV        
Vitamin D status    
PTH    
Nutritionist counseling        
  1. ALAT, alanine aminotransferase; ASAT, aspartate aminotransferase; E, enrolment; γ-GT, gamma glutamyl transferase; HbA1c, glycated hemoglobin; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; M, month; PTH, parathyroid hormone; V, visit W week; . aTo minimize the risk of accidental intoxication, sirolimus trough levels will be measured at every visit. These measurements will only be accessible for nominated nephrologists not otherwise involved in the study to protect blinding of the treating physicians and the patients. The nominated nephrologists will notify the treating physicians in case of trough levels exceeding 20 ng/mL.