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

Primary Purpose

Kidney Diseases, Nephrotic Syndrome, Tacrolimus

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

tacrolimus (FK506)

About this trial

This is an interventional treatment trial for Kidney Diseases focused on measuring Refractory Nephrotic syndrome, Tacrolimus

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Inability or unwillingness to provide written informed consent ;
Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide, azathioprine, corticosteroids;
Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;
Pregnancy, nursing or use of a non-reliable method of contraception;
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;
Previous kidney transplant or planted transplant;
Scr > 4mg/dl (353umol/L);
Active hepatitis, with liver dysfunction;
Diagnosed DM;
Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tacrolimus(fk506) treatment

Arm Description

tacrolimus(fk506) treatment

Outcomes

Primary Outcome Measures

Remission rate

Secondary Outcome Measures

Renal function, proteinuria, relapse

Full Information

NCT ID

NCT00615667

First Posted

February 1, 2008

Last Updated

April 19, 2016

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT00615667

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Diseases, Nephrotic Syndrome, Tacrolimus

Keywords

Refractory Nephrotic syndrome, Tacrolimus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tacrolimus(fk506) treatment

Arm Type

Experimental

Arm Description

tacrolimus(fk506) treatment

Intervention Type

Drug

Intervention Name(s)

tacrolimus (FK506)

Intervention Description

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;

Primary Outcome Measure Information:

Title

Remission rate

Time Frame

2006-2008

Secondary Outcome Measure Information:

Title

Renal function, proteinuria, relapse

Time Frame

2006-2008

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects of either sex, 14-65 years of age; Diagnosis of Nephrotic syndrome with hypoalbuminemia (<3.0g/dl) and heavy proteinuria (> 3.5g/24hr); Provision of written informed consent by subject or guardian; 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: Inability or unwillingness to provide written informed consent ; Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide, azathioprine, corticosteroids; Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization; Pregnancy, nursing or use of a non-reliable method of contraception; 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; Previous kidney transplant or planted transplant; Scr > 4mg/dl (353umol/L); Active hepatitis, with liver dysfunction; Diagnosed DM; Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .

Overall Study Officials: