Status:
COMPLETED
Sirolimus (Rapamune®) for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Lead Sponsor:
University of Zurich
Conditions:
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Eligibility:
All Genders
18-40 years
Phase:
PHASE3
Brief Summary
The aim of our study is to investigate whether Rapamune used at a low dose (2 mg/d) retards cyst growth and slows renal functional deterioration in patients with ADPKD.
Detailed Description
Currently there is no treatment for ADPKD other than supportive care and blood pressure control. Usually dialytic treatment or renal transplantation becomes necessary when the disease has progressed t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00346918
Start Date
June 1 2006
End Date
June 1 2010
Last Update
February 27 2014
Active Locations (1)
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1
University Hospital
Zurich, Canton of Zurich, Switzerland, 8091