A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients W… (NCT01763580) | Clinical Trial Compass
CompletedPhase 4
A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome
South Korea144 participantsStarted 2012-07-16
Plain-language 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.
Who can participate
Age range16 Years – 78 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mor…
What they're measuring
1
The percentage of subjects who show a decreased UPCR (Urine Protein Creatinine Rate) of less than 0.2