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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01763580
Other study ID # PRGNS-11-02-KOR
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 16, 2012
Est. completion date August 21, 2017

Study information

Verified date July 2022
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date August 21, 2017
Est. primary completion date May 2, 2017
Accepts healthy volunteers No
Gender All
Age group 16 Years to 78 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Tacrolimus
Oral
Prednisolone
Oral

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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