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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014