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

NCT ID: NCT00615667

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-09-30

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.

Conditions

Kidney Diseases; Nephrotic Syndrome; Tacrolimus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tacrolimus(fk506) treatment

tacrolimus(fk506) treatment

Group Type: EXPERIMENTAL

tacrolimus (FK506)

Intervention Type: DRUG

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;

Interventions

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;

Intervention Type: DRUG

Eligibility Criteria

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 .

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xue Qing Yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xueqing Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

Ping Fu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, West China Hospital of Sichuan University

Yunhua Liao, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University

Jin li Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of nephrology, People's Hospital of Yunnan Province

Jian Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, Fuzhou Military General Hospital

Tanqi Lou, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University

Yaozhong Kong, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, 1st People's Hospital of Foshan

Junzhou Fu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology,1st People's Hospital of Guangzhou

Wei Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, People's Hospital Guangdong Provincial

Zhengrong Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, Nanfang Hospital of Southern Medical University

Other Identifiers

SYSU-PRGNS-001

Identifier Type: -

Identifier Source: org_study_id