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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 May 2014 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: May 29, 2014
Last verified: May 2014
  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:


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 2015
Estimated Primary Completion Date: November 2014 (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:   14 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〈 2.3 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 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: May 29, 2014
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
Kidney Diseases
Nephritis
Urologic Diseases
Cyclophosphamide
Tacrolimus
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014