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

This study has been completed.
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01309477
First received: February 1, 2011
Last updated: November 1, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Nephrotic Syndrome
Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Remission rate (complete or partial remission) at 6 months [ Time Frame: 6 months after therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • relapse rate [ Time Frame: every 3 months up to 6 months ] [ Designated as safety issue: Yes ]
  • side effects [ Time Frame: every 3 months up to 6 months ] [ Designated as safety issue: Yes ]
    infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance , etc


Estimated Enrollment: 20
Study Start Date: January 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   14 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309477

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

No publications provided

Responsible Party: Xueqing Yu, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01309477     History of Changes
Other Study ID Numbers: SYSU-PRGNS-002
Study First Received: February 1, 2011
Last Updated: November 1, 2011
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Nephrotic Syndrome
Nephrosis
Kidney Diseases
Urologic Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014