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

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).

Study Overview

• Status: Completed
• Conditions: Nephrotic Syndrome
• Intervention / Treatment: Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 56 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: ADVAGRAF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Remission rate (complete or partial remission) at 6 months	6 months after therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
relapse rate		every 3 months up to 6 months
side effects	infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance , etc	every 3 months up to 6 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: February 1, 2011
• First Submitted That Met QC Criteria: March 4, 2011
• First Posted (Estimate): March 7, 2011

Study Record Updates

• Last Update Posted (Estimate): November 2, 2011
• Last Update Submitted That Met QC Criteria: November 1, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Tacrolimus; Refractory Nephrotic Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease; Syndrome; Nephrotic Syndrome; Nephrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: SYSU-PRGNS-002