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

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Nephrotic Syndrome

Treatments: Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)

Study type: Interventional

Funder types: Other

Identifiers

NCT01309477

SYSU-PRGNS-002

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

ADVAGRAF

Experimental group

Description:

All subjects in the study will take the Tacrolimus Sustained-release Capsules (ADVAGRAF) orally at the basis of low dose prednisone treatment

Treatment:

Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)