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

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00615667
• Collaborator: (none)
• Enrollment: 61
• Arm: 1
• Duration (Months): 27

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Diseases; Nephrotic Syndrome; Tacrolimus	Drug: tacrolimus (FK506)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tacrolimus(fk506) treatment 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;

Outcome Measures

Primary Outcome Measures

1. Remission rate [2006-2008]

Secondary Outcome Measures

1. Renal function, proteinuria, relapse [2006-2008]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 .

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

• Principal Investigator: Xueqing Yu, MD, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
• Principal Investigator: Ping Fu, MD, Department of Nephrology, West China Hospital of Sichuan University
• Principal Investigator: Yunhua Liao, MD, Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical 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: 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: Junzhou Fu, MD, Department of Nephrology,1st People's Hospital of Guangzhou
• Principal Investigator: Wei Shi, MD, Department of Nephrology, People's Hospital Guangdong Provincial
• Principal Investigator: Zhengrong Liu, MD, Department of Nephrology, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xue Qing Yu, Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT00615667
• Other Study ID Numbers: SYSU-PRGNS-001
• First Posted: Feb 14, 2008
• Last Update Posted: Apr 20, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Xue Qing Yu, Professor, Sun Yat-sen University: Refractory Nephrotic syndrome; Tacrolimus
• Additional relevant MeSH terms: Kidney Diseases; Nephrotic Syndrome; Nephrosis; Syndrome; Tacrolimus

Study Results

No Results Posted as of Apr 20, 2016