The Efficacy and Tolerance of Tacrolimus Sustained-release Capsules on Refractory Nephrotic Syndrome (RNS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01309477
Recruitment Status : Completed
First Posted : March 7, 2011
Last Update Posted : November 2, 2011
Information provided by:
Sun Yat-sen University

Brief Summary:
It is a pilot study to explore the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) on 6-month induction therapy of Refractory Nephrotic Syndrome (RNS).

Condition or disease Intervention/treatment Phase
Nephrotic Syndrome Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: ADVAGRAF
All subjects in the study will take the Tacrolimus Sustained-release Capsules (ADVAGRAF) orally at the basis of low dose prednisone treatment
Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)
Started: 0.05-0.1mg/kg/d, one time per day, then adjusting the dose to maintain the blood level 5-10ng/ml in the induction treatment .
Other Name: ADVAGRAF

Primary Outcome Measures :
  1. Remission rate (complete or partial remission) at 6 months [ Time Frame: 6 months after therapy ]

Secondary Outcome Measures :
  1. relapse rate [ Time Frame: every 3 months up to 6 months ]
  2. side effects [ Time Frame: every 3 months up to 6 months ]
    infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance , etc

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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects of either sex, 14-60 years of age
  • Diagnosis of Nephrotic syndrome with hypoalbuminemia (< 3.0g/dl) and heavy proteinuria (> 3.5g/24hr) and exclude secondary Nephrotic syndrome
  • Refractory Nephrotic Syndrome

    1. Steroid resistant: failure to respond (either complete or partial remission) after a course of 8 weeks of 1.0 mg/kg/d prednisone or equal dose of steroid therapy
    2. Steroid dependent: recurrence of nephrotic proteinuria during tapering of prednisone at a dose > 10 mg/day or within the first 2 weeks after withdrawal of prednisone
    3. Frequently recurrence: initial remission with steroid induction therapy, but relapsed 2 or more in 6 months or 3 or more within 12 months
    4. Failure to respond (either complete or partial remission) even after CTX, MMF or CsA therapy combined with steroid
  • eGFR ≥ 60 ml/min/1.73 m2
  • Provision of written informed consent by subject or guardian

Exclusion Criteria:

  • Systemic disease
  • eGFR < 60ml/min/1.73m2
  • Diagnosed DM
  • Malignant tumors (except fully cured basal cell carcinoma)
  • Familial nephritic syndrome
  • History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study
  • Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C
  • Known hypersensitivity or contraindication to tacrolimus, corticosteroids
  • Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening
  • Pregnancy, nursing or use of a non-reliable method of contraception
  • Inability or unwillingness to provide written informed consent
  • Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization or intravenous MP Pulse treatment

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 identifier (NCT number): NCT01309477

China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Principal Investigator: Yu Xueqing, MD Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

Responsible Party: Xueqing Yu, Sun Yat-sen University Identifier: NCT01309477     History of Changes
Other Study ID Numbers: SYSU-PRGNS-002
First Posted: March 7, 2011    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: October 2011

Keywords provided by Sun Yat-sen University:
Refractory Nephrotic Syndrome

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