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

Table 2 Trial sequence of The Vienna RAP Study

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 level^a		•	•	•	•	•	•	•
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	•

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.

ISSN: 1745-6215