Clinical trial on use of Saquinavir in patients affected by primitive glomerulonephritis associated to resistant nephrotic syndrome. - ND

Conditions: ephrotic syndrome resistant to standard therapy
MedDRA version: 9.1Level: LLTClassification code 10029164

Registration Number: EUCTR2009-013484-19-IT

Lead Sponsor: OSPEDALE POLICLINICO S. MATTEO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

18-70 years old, affected by primitive nephrotic syndrome resistant to standard therapy
Are the trial subjects under 18? no
Number of subjects for this age range:
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

Severe renal disfunction. Moderate to severe hypertension. Liver disease, infections, malignant tumor, allergy or intolerance to Saquinavir. Patients legally of unsound mind. Patients enrolled in other clinical trial in the previous 3 months. Drug-addicted or alcoholics.Pragnancy or breast-feeding.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate efficacy of Saquinavir on proteinuria and renal insufficiency in resistant nephrotic syndrome;Secondary Objective: 1. Built a registry of NS; 2. Get information on NS pathogenesis; 3. Get information on inflammation process induced by proteinuria;Primary end point(s): Reduction of &#8805; 50% of the proteinuria basal value or of the proteinuria/creatininuria ratio Up/c)with variation of seric creatinine not higher than 10%.

Secondary Outcome Measures