Status:
TERMINATED
Sirolimus In Autosomal Dominant Polycystic Kidney Disease And Severe Renal Insufficiency
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The general aim of this study in adult patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and severe renal insufficiency is to assess the safety and the efficacy of sirolimus (SRL) in ...
Detailed Description
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common hereditary renal disease, responsible for the 8% to 10% of the cases of end-stage renal disease (ESRD) in Western Countries. AD...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Clinical and ultrasound diagnosis of ADPKD
- GFR 40-15 ml/min/1.73 m2 (estimated by the 4 variable MDRD equation)
- Urinary protein excretion rate \< 0.5 g/ 24 hrs
- Written informed consent
Exclusion
- Diabetes
- Urinary protein excretion rate \>0.5 g/ 24 hrs or abnormal urinalysis suggestive of concomitant, clinically significant glomerular disease
- Urinary tract lithiasis, infection or obstruction
- Cancer
- Psychiatric disorders and any condition that might prevent full comprehension of the purposes and risks of the study
- Pregnancy, lactation or child bearing potential and ineffective contraception (estrogen therapy in post menopausal women should not be stopped)
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01223755
Start Date
September 1 2010
End Date
July 1 2012
Last Update
February 25 2013
Active Locations (1)
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1
Mario Negri Institute - Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020