A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-16

Study Completion Date

2017-08-21

Brief Summary

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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.

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Detailed Description

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Conditions

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MCNS Minimal Change Nephrotic Syndrome (MCNS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tacrolimus with low-dose corticosteroid

Oral

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

Oral

Prednisolone

Intervention Type DRUG

Oral

High-dose corticosteroid alone

Oral

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

Oral

Interventions

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Tacrolimus

Oral

Intervention Type DRUG

Prednisolone

Oral

Intervention Type DRUG

Other Intervention Names

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FK506 Prograf Capsule

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No