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

NCT01377246 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-01-10

No results posted yet for this study

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.

Conditions

  • Autosomal Dominant Polycystic Kidney Disease

Interventions

DRUG

Octreotide-LAR

40 mg every 28 days (in two intragluteal 20 mg injections) for three years

OTHER

Saline solution.

At the same volume of study drug every 28 days (in two intragluteal injections) for three years.

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2017-10-18
Completion
2017-10-18

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01377246 on ClinicalTrials.gov