Clinical trial NCT01763580: A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: MCNS
Minimal Change Nephrotic Syndrome (MCNS)
Keywords: Glomerulonephritis
Tacrolimus
Nephrotic syndrome
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-01-09
Enrollment: 144
Sex: ALL
Minimum age (years): 16
Maximum age (years): 78
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The percentage of subjects who show a decreased UPCR (Urine Protein Creatinine Rate) of less than 0.2
timeFrame: up to 8 weeks after treatment
Secondary outcomes:
measure: The period until the UPCR is decreased below 0.2
timeFrame: up to 8 weeks after treatment
measure: The percentage of subjects who show relapse after the remission
timeFrame: up to 24 weeks
measure: The period until the relapse happens from the complete remission
timeFrame: up to 24 weeks
measure: Safety assessed by the incidence of adverse events, labo-tests, vital signs, ECGs and chest X-rays
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
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.