Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal Insufficiency

• Status: Completed
• Trial end date: 2017-10-18
• Target enrollment: 0
• Participant gender: All

Summary

The general aim of the trial is to assess the efficacy of one year treatment with long-acting somatostatin analogue (Octreotide LAR) compared with placebo in slowing kidney and liver growth rate in patients with ADPKD and moderate/severe renal insufficiency and to assess whether and to which extent this translates into slower renal function decline over 3-year follow-up.

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

Details

• Lead Sponsor: Mario Negri Institute for Pharmacological Research
• Treatments: Octreotide; Somatostatin

Criteria

Inclusion Criteria:

• Age > 18 years

• Clinical and ultrasound diagnosis of ADPKD

• Estimated GFR between 15 and 40 ml/min/1.73m2 (by the MDRD 4 variable equation)

• Written informed consent

Exclusion Criteria:

• 24-h Urinary protein excretion rate >3g (suggestive of a concomitant glomerular disease that could benefit of specific therapy)

• Symptomatic urinary tract lithiasis or obstruction

• Uncontrolled diabetes mellitus (HbA1c >8%) or hypertension (systolic/diastolic BP >180/110 mmHg)

• Current urinary tract infection

• Symptomatic biliary tract lithiasis

• Active cancer

• Psychiatric disorders or 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)