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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 November 2024
• Main ID: NCT01763580
• Date of registration: 06/12/2012
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Korea, Inc.
• Public title: A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome T-OPTIMUM
• Scientific 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)
• Date of first enrolment: July 16, 2012
• Target sample size: 144
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01763580
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Korea, Republic of

Contacts

• Name: Medical Director
• Affiliation: Astellas Pharma Inc

Key inclusion & exclusion 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


Age minimum: 16 Years
Age maximum: 78 Years
Gender: All

Health Condition(s) or Problem(s) studied

Minimal Change Nephrotic Syndrome (MCNS)

MCNS

Intervention(s)

Drug: Tacrolimus

Drug: Prednisolone

Primary Outcome(s)

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(s)

The period until the relapse happens from the complete remission [Time Frame: up to 24 weeks]

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

The percentage of subjects who show relapse after the remission [Time Frame: up to 24 weeks]

The period until the UPCR is decreased below 0.2 [Time Frame: up to 8 weeks after treatment]

Secondary ID(s)

PRGNS-11-02-KOR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors