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

NCT01763580 | Completed Phase 4

• 1 other identifier: PRGNS-11-02-KOR
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

MCNS; Minimal Change Nephrotic Syndrome (MCNS)

Keywords

Glomerulonephritis; Tacrolimus; Nephrotic syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The period until the UPCR is decreased below 0.2

  up to 8 weeks after treatment

• The percentage of subjects who show relapse after the remission

  up to 24 weeks

• 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

Study Arms (2)

Tacrolimus with low-dose corticosteroid

EXPERIMENTAL

Oral

Drug: Tacrolimus; Drug: Prednisolone

High-dose corticosteroid alone

ACTIVE COMPARATOR

Oral

Drug: Prednisolone

Interventions

Tacrolimus DRUG

Oral

Also known as: FK506, Prograf Capsule

Tacrolimus with low-dose corticosteroid

Prednisolone DRUG

Oral

High-dose corticosteroid alone; Tacrolimus with low-dose corticosteroid

Eligibility Criteria

• Age: 16 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Korea, Inc.: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

Related Publications (1)

• Azukaitis K, Palmer SC, Strippoli GF, Hodson EM. Interventions for minimal change disease in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2022 Mar 1;3(3):CD001537. doi: 10.1002/14651858.CD001537.pub5.

  PMID: 35230699 DERIVED

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Nephrosis, Lipoid; Glomerulonephritis; Nephrotic Syndrome

Interventions

Tacrolimus; Prednisolone

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephritis

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: January 9, 2013
• Study Start: July 16, 2012
• Primary Completion: May 2, 2017
• Study Completion: August 21, 2017
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)