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

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: Kidney Diseases; Nephrotic Syndrome; Tacrolimus
• Intervention / Treatment: Drug: tacrolimus (FK506)

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 3

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	2006-2008

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

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: Tacrolimus; Refractory Nephrotic syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease; Syndrome; Kidney Diseases; Nephrotic Syndrome; Nephrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: SYSU-PRGNS-001