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

This study is currently recruiting participants.
Verified March 2013 by Nanjing University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT01451489
First received: August 5, 2011
Last updated: March 29, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
FSGS
 Drug: FK506
Drug: Cyclophosphamide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental Glomerulosclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • the rates of the complete remission during the induction phase [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the total remission rates [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 130
Study Start Date: October 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Drug: FK506
FK506:0.05-0.1mg/kg/d
Other Name: Tacrolimus,Prograf

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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 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 CTX or FK506.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451489

Contacts
Contact: Haitao Zhang, MD 86-25-80860218 haitaozh@yahoo.com.cn

Locations
China, Jiangsu
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Haitao Zhang, MD     86-25-80860218 ext 86-25-84801992     haitaozh@yahoo.com.cn    
Principal Investigator: Zhihong Liu, MD            
Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
Study Director: Zhihong Liu, MD Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
  More Information

No publications provided

Responsible Party: Zhi-Hong Liu, M.D., Professor, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT01451489     History of Changes
Other Study ID Numbers: NJCT-1101
Study First Received: August 5, 2011
Last Updated: March 29, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:
FSGS
FK506
CTX

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Cyclophosphamide
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on May 16, 2013