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Clinical Trials/EUCTR2011-000138-12-IT
EUCTR2011-000138-12-IT
Active, not recruiting
Phase 1

A prospective, randomized, double-blind, placebo controlled clinical trial to assess the effects of long-acting somatostatin (Octreotide LAR)therapy on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and moderate to severe renal insufficiency - ALADIN 2

IST. DI RICERCHE FARMACOLOG. M. NEGRI0 sites100 target enrollmentDecember 28, 2011
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DrugsSANDOSTATINA LAR

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Enrollment
100
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 28, 2011
End Date
April 14, 2017
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
IST. DI RICERCHE FARMACOLOG. M. NEGRI

Eligibility 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
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

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)

Outcomes

Primary Outcomes

Not specified

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