focal and segmental glomerulosclerosis
Conditions
Interventions
Trade Name: Neoral
Product Name: Neoral
Pharmaceutical Form: Capsule*
Trade Name: Medrol
Product Name: Medrol
Pharmaceutical Form: Tablet
Trade Name: zestril
Product Name: zestril
Pharmaceutical For
Sponsors
Hopital Erasme
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Male and female patients aged from 18 to 70 years old 2)Patients with initial clinical diagnosis of de novo nephrotic syndrome (i.e. proteinuria > 3 g/d., hypoalbuminemia, hyperlipidemia) and biopsy proven focal segmental glomerulosclerosis. 3)Renal function > 50 ml/min. per 1.73 m² body surface area as measured by a 24 hrs. urine creatinine clearance. 4)Written informed consent should be obtained from participating patients 5)Females of childbearing age should use appropriate contraception. 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: 1)Current malignancies or history of previous malignancies except for treated basal or squamous cell skin carcinoma. 2)Metabolic disorders (including diabetes mellitus patients) or systemic diseases (e.g. lupus,…) 3)Active liver diseases 4)Presence of another kidney disease 5)Disorders of the central nervous system 6)The use of immunosuppressive therapy 3 months prior to the start of the study 7)Kidney transplanted patients 8)Active infection at study entry 9)Known hypersensitivity to ACE-inhibitors or contraindication for ACE-inhibitors 10)Renal artery stenosis 11)Pregnancy or wish to become pregnant during the study period 12)Non-compliance or psychological disorders which may impair the compliance of the patient 13)HIV positive patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to evaluate the association of Neoral with ACE-inhibitors in the treatment of focal segmental glomerulosclerosis as compared to the association of corticosteroids with ACE-inhibitors. Primary efficacy variable: Percent patients into complete remission at month 6 ;Secondary Objective: -Renal function assessed by serum creatinine and by calculated GFR at months 6,12 and 24 -Change in renal function versus baseline assessed at months 6,12 and 24 -Percent patients into complete remission at months 12 and 24 -Percent patients into partial remission at months 6, 12 and 24 -Percent patients with no remission at months 6, 12 and 24 -Percent patients where dialysis was required -Percent patients where serum creatinine values doubled -Blood pressure, percent of patients on hyotensive therapy, and N° of hypotensive drugs per patient at months 6, 12 and 24 -Total cholesterol, HDL- and LDL-cholesterol, triglycerides levels; percent of patients on hypolipemic therapy and type of drug administered (statins or fibrates) at months 6, 12 and 24. ;Primary end point(s): Percent patients into complete remission at month 6 | — |
Countries
Belgium
Outcome results
None listed