Back to resultsA Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome (T-OPTIMUM)
Primary Purpose
MCNS, Minimal Change Nephrotic Syndrome (MCNS)
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tacrolimus
Prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for MCNS focused on measuring Glomerulonephritis, Tacrolimus, Nephrotic syndrome
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tacrolimus with low-dose corticosteroid
High-dose corticosteroid alone
Arm Description
Oral
Oral
Outcomes
Primary Outcome Measures
The percentage of subjects who show a decreased UPCR (Urine Protein Creatinine Rate) of less than 0.2
Secondary Outcome Measures
The period until the UPCR is decreased below 0.2
The percentage of subjects who show relapse after the remission
The period until the relapse happens from the complete remission
Safety assessed by the incidence of adverse events, labo-tests, vital signs, ECGs and chest X-rays
Full Information
NCT ID
NCT01763580
First Posted
December 6, 2012
Last Updated
July 26, 2022
Sponsor
Astellas Pharma Korea, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01763580
Brief Title
A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome
Acronym
T-OPTIMUM
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 16, 2012 (Actual)
Primary Completion Date
May 2, 2017 (Actual)
Study Completion Date
August 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Korea, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MCNS, Minimal Change Nephrotic Syndrome (MCNS)
Keywords
Glomerulonephritis, Tacrolimus, Nephrotic syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tacrolimus with low-dose corticosteroid
Arm Type
Experimental
Arm Description
Oral
Arm Title
High-dose corticosteroid alone
Arm Type
Active Comparator
Arm Description
Oral
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
FK506, Prograf Capsule
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Oral
Primary Outcome Measure Information:
Title
The percentage of subjects who show a decreased UPCR (Urine Protein Creatinine Rate) of less than 0.2
Time Frame
up to 8 weeks after treatment
Secondary Outcome Measure Information:
Title
The period until the UPCR is decreased below 0.2
Time Frame
up to 8 weeks after treatment
Title
The percentage of subjects who show relapse after the remission
Time Frame
up to 24 weeks
Title
The period until the relapse happens from the complete remission
Time Frame
up to 24 weeks
Title
Safety assessed by the incidence of adverse events, labo-tests, vital signs, ECGs and chest X-rays
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Citations:
PubMed Identifier
35230699
Citation
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.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=257
Description
Link to results on the Astellas Clinical Study Results website
Learn more about this trial
A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome
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