Overview

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)