Multicenter, pilot, open, randomized, parallel group study to evaluate the association of Neoral with ACE-inhibitors as compared to ACE-inhibitors alone in the treatment of de novo nephrotic syndrome due to idiopathic membranous glomerulopathy

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2005-004469-40-BE
• Date of registration: 05/12/2005
• Prospective Registration: Yes
• Primary sponsor: Hopital Erasme
• Public title: Multicenter, pilot, open, randomized, parallel group study to evaluate the association of Neoral with ACE-inhibitors as compared to ACE-inhibitors alone in the treatment of de novo nephrotic syndrome due to idiopathic membranous glomerulopathy
• Scientific title: Multicenter, pilot, open, randomized, parallel group study to evaluate the association of Neoral with ACE-inhibitors as compared to ACE-inhibitors alone in the treatment of de novo nephrotic syndrome due to idiopathic membranous glomerulopathy
• Date of first enrolment: 12/05/2006
• Target sample size: 50
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004469-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion criteria:
1) Male and female patients aged from 18 to 70 years old.
2) Patients with initial (in order to exclude those with relapses, and to make the group more homogeneous) clinical diagnosis of de novo nephrotic syndrome (i.e. proteinuria > 3 g/d., hypoalbuminemia, hyperlipidemia) and biopsy proven membranous nephropathy.
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Membranous Nephropathy

Intervention(s)

Trade Name: Neoral
Product Name: Neoral
Pharmaceutical Form: Capsule*

Trade Name: zestril
Product Name: zestril
Pharmaceutical Form: Tablet

Primary Outcome(s)

Main Objective: The aim of this study is to compare among patients suffering from membranous nephropathy therapy with cyclosporine A together with an angiotensin-converting enzyme inhibitor to an angiotensin-converting enzyme inhibitor alone on the proportion of patients achieving complete remission at the of month 6 (no proteinuria or proteinuria <0.5 gr/d).

Primary end point(s): Percent patients into complete remission at the end of month 6 (no proteinuria or proteinuria <0.5 gr/d).

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.

Secondary ID(s)

5022005