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The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis (FSGS)

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ClinicalTrials.gov Identifier: NCT01451489
Recruitment Status : Terminated (The recruitment of subject is very difficult)
First Posted : October 13, 2011
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
FSGS Drug: FK506 Drug: Cyclophosphamide Not Applicable

Detailed Description:
  1. Using the response rate and completely response time to compare the efficacy of FK506 versus CTX therapy for the severe FSGS patients.
  2. To compare the safety and tolerability of FK506 versus CTX for the severe FSGS patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental Glomerulosclerosis
Actual Study Start Date : October 13, 2011
Actual Primary Completion Date : March 23, 2016
Actual Study Completion Date : October 29, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cyclophosphamide
CTX
 Drug: Cyclophosphamide
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 Name: CTX
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.
 Drug: FK506
FK506:0.05-0.1mg/kg/d
Other Name: Tacrolimus,Prograf


Outcome Measures
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Primary Outcome Measures :
  1. the rates of the complete remission during the induction phase [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. the total remission rates [ Time Frame: 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT01451489


Locations
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China, Jiangsu
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
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Study Director: Zhihong Liu, MD Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zhi-Hong Liu, M.D., Professor, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT01451489    
Other Study ID Numbers: NJCT-1101
First Posted: October 13, 2011    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Keywords provided by Zhi-Hong Liu, M.D., Nanjing University School of Medicine:
FSGS
FK506
CTX
Additional relevant MeSH terms:
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Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Cyclophosphamide
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Calcineurin Inhibitors
Enzyme Inhibitors