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

NCT01451489 | Terminated DMC

• 1 other identifier: NJCT-1101
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

FSGS

Keywords

FSGS; FK506; CTX

Outcome Measures

Primary Outcomes (1)

• the rates of the complete remission during the induction phase

  6 months

Secondary Outcomes (1)

• the total remission rates

  18 months

Study Arms (2)

Cyclophosphamide

ACTIVE COMPARATOR

CTX

Drug: Cyclophosphamide

FK506

EXPERIMENTAL

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

Interventions

FK506 DRUG

FK506:0.05-0.1mg/kg/d

Also known as: Tacrolimus,Prograf

FK506

Cyclophosphamide DRUG

CTX 750mg/m2 per month in the induction phase,then 750mg/m2 every 2 month for 3 times,then 750mg/m2 every 3 months.

Also known as: CTX

Cyclophosphamide

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing University School of Medicine: lead

Study Sites (1)

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Nanjing, Jiangsu, 210002, China

Location

Related Publications (1)

• Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.

  PMID: 35224732 DERIVED

MeSH Terms

Interventions

Tacrolimus; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds

Study Officials

• Zhihong Liu, MD

  Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: October 13, 2011
• Study Start: October 13, 2011
• Primary Completion: March 23, 2016
• Study Completion: October 29, 2016
• Last Updated: March 27, 2017

Record last verified: 2017-03

Locations

CN (1)