Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01763580
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )

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.

Condition or disease Intervention/treatment Phase
MCNS Minimal Change Nephrotic Syndrome (MCNS) Drug: Tacrolimus Drug: Prednisolone Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Actual Study Start Date : July 16, 2012
Actual Primary Completion Date : May 2, 2017
Actual Study Completion Date : August 21, 2017


Arm Intervention/treatment
Experimental: Tacrolimus with low-dose corticosteroid
Oral
Drug: Tacrolimus
Oral
Other Names:
  • FK506
  • Prograf Capsule

Drug: Prednisolone
Oral

Active Comparator: High-dose corticosteroid alone
Oral
Drug: Prednisolone
Oral




Primary Outcome Measures :
  1. 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 Measures :
  1. The period until the UPCR is decreased below 0.2 [ Time Frame: up to 8 weeks after treatment ]
  2. The percentage of subjects who show relapse after the remission [ Time Frame: up to 24 weeks ]
  3. The period until the relapse happens from the complete remission [ Time Frame: up to 24 weeks ]
  4. Safety assessed by the incidence of adverse events, labo-tests, vital signs, ECGs and chest X-rays [ Time Frame: up to 24 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 78 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763580


Locations
Layout table for location information
Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Korea, Inc.
Investigators
Layout table for investigator information
Study Director: Medical Director Astellas Pharma Inc
Additional Information:
Layout table for additonal information
Responsible Party: Astellas Pharma Korea, Inc.
ClinicalTrials.gov Identifier: NCT01763580    
Other Study ID Numbers: PRGNS-11-02-KOR
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL: https://www.clinicalstudydatarequest.com/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Korea, Inc. ):
Glomerulonephritis
Tacrolimus
Nephrotic syndrome
Additional relevant MeSH terms:
Layout table for MeSH terms
Nephrotic Syndrome
Nephrosis
Nephrosis, Lipoid
Syndrome
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Prednisolone
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents