A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome (T-OPTIMUM)

Astellas

Status and phase: Completed; Phase 4

Conditions: Minimal Change Nephrotic Syndrome (MCNS); MCNS

Treatments: Drug: Prednisolone; Drug: Tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01763580

PRGNS-11-02-KOR

Details and patient eligibility

About

To compare the therapeutic effect of tacrolimus in combination with low-dose corticosteroid with high-dose corticosteroid alone in patients with minimal-change nephrotic syndrome.

Enrollment: 144 patients

Sex: All

Ages: 16 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who have been diagnosed with initial or relapsed primary minimal-change nephrotic syndrome
• patients whose urine protein-creatinine ratio (UPCR) is more than 3.0

Exclusion criteria

• patients whose eGFR is less than 30 ml/min/1.73 m2
• patients who were treated with immunosuppressants, such as tacrolimus, cyclosporine, cyclophosphamide (Cytoxan), mizoribine (Bredinin), levamisole, azathioprine, mycophenolate mofetil, or rituximab, within two weeks before the study
• patients to whom more than 10 mg prednisolone or an equivalent dose of steroid was administered daily within two weeks before the study
• patients who are pregnant, breastfeeding, or planning to be pregnant or to breastfeed within six months after the study completion, or who cannot or do not want to use any contraceptive method
• patients who are hypersensitive to the investigational drug or to macrolide, such as azithromycin, clarithromycin, or roxithromycin
• patients who were treated with a live vaccine within four weeks before the study
• patients whose liver panel laboratory test result is three times the normal range, or acute hepatitis patients whose serum bilirubin has been clinically significantly higher than 3.6 mg/dL for more than 1 month
• patients who have a significant general disease that makes it inappropriate for them to participate in this study as adjudged by the investigator (e.g., cardiovascular-acute myocardial infarction, heart failure [classified as more than New York Heart Association {NYHA} class III], hepatic/gastrointestinal/neurologic disease, blood disorder, cancer, infection, renal disorder other than minimal-change nephrotic syndrome, rheumatic arthritis with pneumonia interstitials)
• patients who have genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
• patients to whom another investigational drug was administered within 30 days from the enrollment in the study
• patients who participated in the past phases of this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Tacrolimus with low-dose corticosteroid

Experimental group

Description:

Oral

Treatment:

Drug: Tacrolimus

Drug: Prednisolone

High-dose corticosteroid alone

Active Comparator group

Description:

Oral

Treatment:

Drug: Prednisolone