A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome (T-OPTIMUM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )
ClinicalTrials.gov Identifier:
NCT01763580
First received: December 6, 2012
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Minimal Change Nephrotic Syndrome (MCNS)
MCNS
Drug: Tacrolimus
Drug: Prednisolone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The period until the UPCR is decreased below 0.2 [ Time Frame: up to 8 weeks after treatment ] [ Designated as safety issue: No ]
  • The percentage of subjects who show relapse after the remission [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • The period until the relapse happens from the complete remission [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Safety assessed by the incidence of adverse events, labo-tests, vital signs, ECGs and chest X-rays [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 152
Study Start Date: June 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus with low-dose corticosteroid Drug: Tacrolimus
Oral
Other Name: FK506, Prograf Capsule
Drug: Prednisolone
Oral
Active Comparator: High-dose corticosteroid alone Drug: Prednisolone
Oral

  Eligibility

Ages Eligible for Study:   16 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763580

Contacts
Contact: Clinical Development Administration Dept. clintrialtrials_info@jp.astellas.com

Locations
Korea, Republic of
Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Korea, Inc.
Investigators
Study Director: Medical Director Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )
ClinicalTrials.gov Identifier: NCT01763580     History of Changes
Other Study ID Numbers: PRGNS-11-02-KOR
Study First Received: December 6, 2012
Last Updated: January 7, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Nephrotic syndrome
Tacrolimus
Glomerulonephritis

Additional relevant MeSH terms:
Syndrome
Nephrotic Syndrome
Nephrosis, Lipoid
Disease
Pathologic Processes
Nephrosis
Kidney Diseases
Urologic Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014