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

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ClinicalTrials.gov Identifier: NCT00615667
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

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;



Primary Outcome Measures :
  1. Remission rate [ Time Frame: 2006-2008 ]

Secondary Outcome Measures :
  1. Renal function, proteinuria, relapse [ Time Frame: 2006-2008 ]


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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615667


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

Responsible Party: Xue Qing Yu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00615667     History of Changes
Other Study ID Numbers: SYSU-PRGNS-001
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

Keywords provided by Xue Qing Yu, Sun Yat-sen University:
Refractory Nephrotic syndrome
Tacrolimus

Additional relevant MeSH terms:
Syndrome
Kidney Diseases
Nephrotic Syndrome
Nephrosis
Disease
Pathologic Processes
Urologic Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action