Clinical trial NCT01309477: The Efficacy and Tolerance of Tacrolimus Sustained-release Capsules on Refractory Nephrotic Syndrome (RNS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nephrotic Syndrome
Keywords: Refractory Nephrotic Syndrome
Tacrolimus
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2011-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Remission rate (complete or partial remission) at 6 months
timeFrame: 6 months after therapy
Secondary outcomes:
measure: relapse rate
timeFrame: every 3 months up to 6 months
measure: side effects
timeFrame: every 3 months up to 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
name: Yu Xueqing, MD
role: PRINCIPAL_INVESTIGATOR
References: