Sirolimus (Rapamune®) for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
About this trial
This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease (ADPKD) focused on measuring ADPKD, autosomal dominant polycystic kidney disease, Sirolimus, volumetry
Eligibility Criteria
Inclusion Criteria: Male or female ADPKD patient between 18 and 40 years of age measured GFR higher than 70 ml/min 1.73m2 documented kidney volume progression informed consent Exclusion Criteria: Female of childbearing potential who is planning to become pregnant, who is pregnant and/or lactating, 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 any past or present malignancy mental illness that interfere 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 co-medication with strong CYP3A4 and or P-gp inductor like rifampicin known hypersensitivity to macrolides or Rapamune
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1
2
Treatment of hypertension, cyst infections and flank pain
Sirolimus plus Standard Treatment