Trial on the therapeutic effect of Tacrolimus in combination with low dosage corticosteroids compared with high dosage corticosteroids only, in patients with minimal change necrotic syndrome

• Conditions: Minimal change nephrotic syndrome; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-001039-18-Outside-EU/EEA
• Lead Sponsor: Astellas Pharma Korea, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-03
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

1) Male or female patients aged 16 or over–under 80
2) Patients who have been diagnosed with initial or relapsed primary minimal change nephrotic syndrome through a renal biopsy
3) Patients whose urine protein creatinine ratio (UPCR) measured at the screening visit is 3.0 or above (spot urine)

Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1) Patients whose MDRD eGFR < 30 ml/min/1.73m2
2) Patients who were treated with immunosuppressants, such as tacrolimus, cyclosporine, cyclophosphamide (Cytoxan), mizoribine (Bredinin), levamisole, azathioprine, mycophenolate mofetil or rituximab within two weeks before this clinical trial
3) Patients to whom more than 10 mg prednisolone or an equivalent dose of steroid was administered daily within two weeks before this clinical trial
4) Patients who are pregnant, breastfeeding, or planning to be pregnant or to breastfeed within six months after the study completion, or females of childbearing potential who do not agree to use effective contraceptive methods
5) Patients who are hypersensitive to the investigational drug or to macrolides, such as azithromycin, clarithromycin, or roxithromycin
6) Patients who are taking bosentan (Tracleer tablets)
7) Patients who are taking potassium-sparing diuretics
8) Patients who were treated with a live vaccine within four weeks before V1
9) Patients whose liver function test result is three times the upper limit of normal or clinically significant acute hepatitis patients whose serum bilirubin has been higher than 3.6 mg/dL for more than 1 month
10) Patients who have a significant general disease that makes it inappropriate for them to participate in this clinical trial as judged by the investigator (e.g., cardiovascular-acute myocardial infarction, heart failure classified as more than NYHA class III, hepatic/gastrointestinal/neurologic disease, blood disorder, cancer, infection, renal disorder other than minimal change nephrotic syndrome, rheumatoid arthritis with pneumonia interstitials, herpes simplex, herpes zoster, chicken pox, etc.)
11) Patients who have genetic problems, such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
12) Patients to whom another investigational drug was administered within the last 30 days

Study & Design

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