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Status:

COMPLETED

Somatostatin in Polycystic Kidney: a Long-term Three Year Follow up Study

Lead Sponsor:

Mario Negri Institute for Pharmacological Research

Conditions:

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Eligibility:

All Genders

18-75 years

Phase:

PHASE3

Brief Summary

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common hereditary renal disease, responsible for 8% to 10% of the cases of end stage renal disease (ESRD) in Western countries. At comp...

Detailed Description

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common hereditary renal disease, responsible for 8% to 10% of the cases of end stage renal disease (ESRD) in Western countries. At com...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Age\>18 years
  • Clinical and ultrasound diagnosis of ADPKD
  • GFR \>40 ml/min/1-73 m2 (estimated by the 4 variable MDRD equation)
  • Written informed consent
  • Exclusion Criteria
  • Diabetes
  • Overt proteinuria (urinary protein excretion rate \>1g/24 hours) 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)

Exclusion

    Key Trial Info

    Start Date :

    April 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2012

    Estimated Enrollment :

    78 Patients enrolled

    Trial Details

    Trial ID

    NCT00309283

    Start Date

    April 1 2006

    End Date

    January 1 2012

    Last Update

    April 24 2013

    Active Locations (5)

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    Page 1 of 2 (5 locations)

    1

    University "Federico II" of Naples

    Napoli, Napoli, Italy

    2

    Hospital Cà Foncello

    Treviso, Treviso, Italy

    3

    Hospital "Ospedali Riuniti" Unit of Nephrology and Dialysis

    Bergamo, Italy, 24128

    4

    Hospital "V. Fazzi" - Unit of neprology and Dialysis

    Lecce, Italy