Sirolimus In Autosomal Dominant Polycystic Kidney Disease And Severe Renal Insufficiency

• Status: Terminated
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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 slowing renal function decline as compared to conventional therapy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mario Negri Institute for Pharmacological Research
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)