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

Phase 4

Completed

• Conditions: MCNS; Minimal Change Nephrotic Syndrome (MCNS)
• Interventions: Drug: Prednisolone; Drug: Tacrolimus

• Registration Number: NCT01763580
• Lead Sponsor: Astellas Pharma Korea, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-16
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Primary Completion: 2017-05-02
• Study Completion: 2017-08-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose corticosteroid alone	Prednisolone	Oral
Tacrolimus with low-dose corticosteroid	Tacrolimus	Oral
Tacrolimus with low-dose corticosteroid	Prednisolone	Oral

Primary Outcome Measures

Name	Time	Method
The percentage of subjects who show a decreased UPCR (Urine Protein Creatinine Rate) of less than 0.2	up to 8 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
The period until the UPCR is decreased below 0.2	up to 8 weeks after treatment
The period until the relapse happens from the complete remission	up to 24 weeks
Safety assessed by the incidence of adverse events, labo-tests, vital signs, ECGs and chest X-rays	up to 24 weeks
The percentage of subjects who show relapse after the remission	up to 24 weeks