Clinical trial NCT00615667: Prospective, Multicenter Study of the Efficacy and Tolerance of Tacrolimus on Refractory Nephrotic Syndrome (RNS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Diseases
Nephrotic Syndrome
Tacrolimus
Keywords: Refractory Nephrotic syndrome
Tacrolimus
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2008-02-14
Enrollment: 61
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 .

Primary outcomes:
measure: Remission rate
timeFrame: 2006-2008
Secondary outcomes:
measure: Renal function, proteinuria, relapse
timeFrame: 2006-2008
Other outcomes:
Locations:
Study officials:
affiliation: Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
name: Xueqing Yu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, West China Hospital of Sichuan University
name: Ping Fu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University
name: Yunhua Liao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of nephrology, People's Hospital of Yunnan Province
name: Jin li Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, Fuzhou Military General Hospital
name: Jian Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, 3rd Affiliated Hospital of Sun Yet-Sen University
name: Tanqi Lou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, 1st People's Hospital of Foshan
name: Yaozhong Kong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology,1st People's Hospital of Guangzhou
name: Junzhou Fu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, People's Hospital Guangdong Provincial
name: Wei Shi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, Nanfang Hospital of Southern Medical University
name: Zhengrong Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: