Prospective, Multicenter Study of the Efficacy and Tolerance of Tacrolimus on Refractory Nephrotic Syndrome (RNS)

April 19, 2016 updated by: Xue Qing Yu, Sun Yat-sen University
Exploring the efficacy and safety of Tacrolimus on refractory nephrotic syndrome ; Acquiring the experience of Tacrolimus on the treatment of refractory nephrotic syndrome in Chinese patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects of either sex, 14-65 years of age;
  2. Diagnosis of Nephrotic syndrome with hypoalbuminemia (<3.0g/dl) and heavy proteinuria (> 3.5g/24hr);
  3. Provision of written informed consent by subject or guardian;
  4. Refractory nephrotic syndrome:

Steroid resistant: Persistence of proteinuria despite prednisone therapy 1mg/kg/d for 16 weeks; Steroid dependent: NS recurs when steroid dosage decease.Twice within 6 months, and 3 times within 1 year.

Exclusion Criteria:

  1. Inability or unwillingness to provide written informed consent ;
  2. Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide, azathioprine, corticosteroids;
  3. Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;
  4. Pregnancy, nursing or use of a non-reliable method of contraception;
  5. Continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;
  6. Previous kidney transplant or planted transplant;
  7. Scr > 4mg/dl (353umol/L);
  8. Active hepatitis, with liver dysfunction;
  9. Diagnosed DM;
  10. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tacrolimus(fk506) treatment
Drug: tacrolimus (FK506)
Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Remission rate
Time Frame: 2006-2008
2006-2008

Secondary Outcome Measures

Outcome Measure
Time Frame
Renal function, proteinuria, relapse
Time Frame: 2006-2008
2006-2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Xueqing Yu, MD, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
  • Principal Investigator: Junzhou Fu, MD, Department of Nephrology,1st People's Hospital of Guangzhou
  • Principal Investigator: Ping Fu, MD, Department of Nephrology, West China Hospital of Sichuan University
  • Principal Investigator: Jin li Zhang, MD, Department of nephrology, People's Hospital of Yunnan Province
  • Principal Investigator: Jian Chen, MD, Department of Nephrology, Fuzhou Military General Hospital
  • Principal Investigator: Wei Shi, MD, Department of Nephrology, People's Hospital Guangdong Provincial
  • Principal Investigator: Yunhua Liao, MD, Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University
  • Principal Investigator: Tanqi Lou, MD, Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University
  • Principal Investigator: Yaozhong Kong, MD, Department of Nephrology, 1st People's Hospital of Foshan
  • Principal Investigator: Zhengrong Liu, MD, Department of Nephrology, Nanfang Hospital of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 1, 2008

First Submitted That Met QC Criteria

February 1, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSU-PRGNS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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