Levamisole treatment for children with steroid sensitive nephrotic syndrome.

Levamisole treatment for children with steroid sensitive nephrotic syndrome. A multicentre, double-blind, placebo-controlled, randomised trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26305

Enrollment

100

Registered

2009-04-20

Start date

2007-05-23

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

steroid sensitive idiopathic nephrotic syndrome(steroid gevoelig idiopathisch nefrotisch syndroom), relapse (recidief), levamisole, steroid side effects (steroid bijwerkingen),

Interventions

1. Active compound Levamisole Hydrochloride. Dosage 2,5 mg/kg on alternate days. Strength 5, 10, 25 and 50 mg. Dosage form oral tablets, coated and non-dividable for taste-masking. 2. Placebo matc

2. Duration: 12 months or until relapse Concomitant medication. Cyclosporine, Cyclophosphamide, MMF and other immunosuppressive drugs are not permitted. Prednisone:given at inclusion during relapse

Eligibility

Inclusion criteria

Inclusion criteria: 1. Primary diagnosis: frequently relapsing idiopathic Steroid Sensitive Nephrotic Syndrome with or without steroid dependency; 2. 2 > Age < 18 years; 3. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients previously treated with Levamisole; 2. Patients unresponsive to Cyclosporine or MMF; 3. Nephrotic syndrome due to a specific kidney disease (such as Henoch –Schoenlein purpura, acute infectious glomerulonefritis, Lupus erythematosus or associated with Hepatitis B or C…); 4. Patients presenting with neutropenia, convulsions or with hepatic diseases; 5. Patients with a prolongation of the QTc-time on the surface electrocardiogram; 6. Pregnancy, breast-feeding or planned pregnancy during the study; 7. Participation in another trial.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is defined as the time to relapse which is the time between start of the study medication and occurrence of a relapse or, in case of no relapse, time of censoring (12 months after start of trial medication). Only a relapse necessitating prednisone treatment is considered a primary endpoint relapse. Proposed end of the blinded part of the study is in all patients 12 months after start of the study medication.	—

Measure

Time frame

The primary endpoint is defined as the time to relapse which is the time between start of the study medication and occurrence of a relapse or, in case of no relapse, time of censoring (12 months after start of trial medication). Only a relapse necessitating prednisone treatment is considered a primary endpoint relapse. Proposed end of the blinded part of the study is in all patients 12 months after start of the study medication.

—

Secondary

Measure	Time frame
1. Average quantity in milligrams of steroids administered per month during the study; 2. Evaluation whether treatment effect differs with underlying disease process (steroid dependency yes/no) and prior use of disease modifying agents (yes/no); 3. Maintenance dose prednisone at time of relapse.	—

Contacts

Public ContactM. Gruppen

m.p.gruppen@amc.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)