- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01451489
The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis (FSGS)
March 22, 2017 updated by: Zhi-Hong Liu, M.D., Nanjing University School of Medicine
A Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental Glomerulosclerosis
This is a prospective,multicentre study to compare the efficacy, safety, tolerability and relapse of FK506 versus CTX in the treatment of severe Focal Segmental Glomerulosclerosis (FSGS).
Study Overview
Detailed Description
- Using the response rate and completely response time to compare the efficacy of FK506 versus CTX therapy for the severe FSGS patients.
- To compare the safety and tolerability of FK506 versus CTX for the severe FSGS patients.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210002
- Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with a diagnosis of FSGS.
- Patients with a proteinuria ≥ 3.5g/24h,and blood albumin <30g/L,and Scr< 2.3 mg/dl and eGFR>30ml/min per 1.73m2.
- Patients who signed written informed consent form (patients less than 18 years old with their parents/legal representative's signatures), and have given their consent to follow all study procedures and follow-up.
Exclusion Criteria:
- Patients who have received treatment of FK506 in latest 2 month or the cumulative dose CTX≥6 g.
- Patients who are known to be allergic to a macrolide.
- Patients who have active hepatitis.
- Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit .
- Patients with blood leukocyte < 3000/ul.
- Patients with kidney disease family history
- Patients with 2 type diabetes.
- Patients with obesity whose BMI>28kg/m2.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cyclophosphamide
CTX
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CTX 750mg/m2 per month in the induction phase,then 750mg/m2 every 2 month for 3 times,then 750mg/m2 every 3 months.
Other Names:
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Experimental: FK506
0.05-0.1mg/kg/d;adjust the dose according the serum concentration(aim 5-10ng/ml),maximum dose 6mg/day;divided in twice, interval 12 hours.
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FK506:0.05-0.1mg/kg/d
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the rates of the complete remission during the induction phase
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the total remission rates
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Zhihong Liu, MD, Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 13, 2011
Primary Completion (Actual)
March 23, 2016
Study Completion (Actual)
October 29, 2016
Study Registration Dates
First Submitted
August 5, 2011
First Submitted That Met QC Criteria
October 11, 2011
First Posted (Estimate)
October 13, 2011
Study Record Updates
Last Update Posted (Actual)
March 27, 2017
Last Update Submitted That Met QC Criteria
March 22, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Nephritis
- Glomerulonephritis
- Glomerulosclerosis, Focal Segmental
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Calcineurin Inhibitors
- Cyclophosphamide
- Tacrolimus
Other Study ID Numbers
- NJCT-1101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on FSGS
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University of North Carolina, Chapel HillMallinckrodtWithdrawnKidney Transplantation | Renal Transplantation | FSGSUnited States
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Dimerix Bioscience Pty LtdRecruitingFSGSUnited States, Argentina, Australia, Denmark, France, Hong Kong, New Zealand, Spain, Taiwan, United Kingdom, Brazil
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Guangdong Provincial People's HospitalUnknown
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University of Colorado, DenverActive, not recruiting
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George W. BurkeNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Genentech... and other collaboratorsTerminated
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Ruijin HospitalRecruitingGlomerulonephritis | IgA Nephropathy | FSGS | Bortezomib | MN | MPGNChina
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National Institute of Diabetes and Digestive and...Genentech, Inc.; Indiana UniversityCompletedFocal Segmental Glomerulosclerosis (FSGS)United States
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ChemoCentryxMedpace, Inc.CompletedFocal Segmental Glomerulosclerosis | FSGS | GlomerulosclerosisUnited States, France, Italy, Australia, United Kingdom, Canada, New Zealand, Poland
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Astellas Pharma Global Development, Inc.Kyowa Kirin Co., Ltd.CompletedKidney Transplantation | Primary Focal Segmental Glomerulosclerosis (FSGS)United States, Canada
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