Nephrotic syndrome resistant to standard therapy MedDRA version: 9.1 Level: LLT Classification code 10029164
Conditions
Interventions
Trade Name: INVIRASE
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Saquinavir
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 500-
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ≥ 50% of the proteinuria basal value or of the proteinuria/creatininuria ratio Up/c)with variation of seric creatinine not higher than 10%. | — |
Countries
Italy
Outcome results
None listed