Clincosm LogoSign in Get a demo

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

Sponsor
Astellas Pharma Korea, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01763580
Collaborator
(none)
144
Enrollment
1
Location
2
Arms
61.2
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap.®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS)
Actual Study Start Date :
Jul 16, 2012
Actual Primary Completion Date :
May 2, 2017
Actual Study Completion Date :
Aug 21, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tacrolimus with low-dose corticosteroid

Oral

Drug: Tacrolimus
Oral
Other Names:
  • FK506
  • Prograf Capsule

    • Drug: Prednisolone
    Oral
    Active Comparator: High-dose corticosteroid alone

    Oral

    Drug: Prednisolone
    Oral

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. The period until the UPCR is decreased below 0.2 [up to 8 weeks after treatment]

    2. The percentage of subjects who show relapse after the remission [up to 24 weeks]

    3. The period until the relapse happens from the complete remission [up to 24 weeks]

    4. Safety assessed by the incidence of adverse events, labo-tests, vital signs, ECGs and chest X-rays [up to 24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 78 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul Korea, Republic of

    Sponsors and Collaborators

    • Astellas Pharma Korea, Inc.

    Investigators

    • Study Director: Medical Director, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Korea, Inc.
    ClinicalTrials.gov Identifier:
    NCT01763580
    Other Study ID Numbers:
    • PRGNS-11-02-KOR
    First Posted:
    Jan 9, 2013
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Astellas Pharma Korea, Inc.
    Glomerulonephritis
    Tacrolimus
    Nephrotic syndrome
    Additional relevant MeSH terms:
    Nephrotic Syndrome
    Nephrosis
    Nephrosis, Lipoid
    Syndrome
    Prednisolone
    Tacrolimus

    Study Results

    No Results Posted as of Jul 27, 2022