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

NCT00615667 | Completed Phase 3 DMC

• 1 other identifier: SYSU-PRGNS-001
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

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

Keywords

Refractory Nephrotic syndrome; Tacrolimus

Outcome Measures

Primary Outcomes (1)

• Remission rate

  2006-2008

Secondary Outcomes (1)

• Renal function, proteinuria, relapse

  2006-2008

Study Arms (1)

tacrolimus(fk506) treatment

EXPERIMENTAL

tacrolimus(fk506) treatment

Drug: tacrolimus (FK506)

Interventions

tacrolimus (FK506) 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;

tacrolimus(fk506) treatment

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Kidney Diseases; Nephrotic Syndrome

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrosis

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 14, 2008
• Study Start: June 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: April 20, 2016

Record last verified: 2016-04