Multicenter, pilot, open, randomized, parallel group study to evaluate the association of Neoral with ACE-inhibitors as compared to corticosteroids with ACE-inhibitors in the treatment of de novo nephrotic syndrome due to focal segmental glomerulosclerosis.

• Conditions: focal and segmental glomerulosclerosis

• Registration Number: EUCTR2005-004460-22-BE
• Lead Sponsor: Hopital Erasme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-05
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified