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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Nanjing University School of Medicine
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine Identifier:
First received: August 5, 2011
Last updated: March 31, 2015
Last verified: March 2015
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
Drug: FK506
Drug: Cyclophosphamide

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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 ]

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

Estimated Enrollment: 130
Study Start Date: October 2011
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cyclophosphamide
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
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.

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

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
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 identifier: NCT01451489

Contact: Haitao Zhang, MD 86-25-80860218

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   
Principal Investigator: Zhihong Liu, MD         
Sponsors and Collaborators
Nanjing University School of Medicine
Study Director: Zhihong Liu, MD Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
  More Information

Responsible Party: Zhi-Hong Liu, M.D., Professor, Nanjing University School of Medicine Identifier: NCT01451489     History of Changes
Other Study ID Numbers: NJCT-1101 
Study First Received: August 5, 2011
Last Updated: March 31, 2015

Keywords provided by Nanjing University School of Medicine:

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Kidney Diseases
Urologic Diseases
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 processed this record on February 24, 2017