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

NCT01309477 | Completed Phase 3 DMC

• 1 other identifier: SYSU-PRGNS-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Nephrotic Syndrome

Keywords

Refractory Nephrotic Syndrome; Tacrolimus

Outcome Measures

Primary Outcomes (1)

• Remission rate (complete or partial remission) at 6 months

  6 months after therapy

Secondary Outcomes (2)

• relapse rate

  every 3 months up to 6 months

• side effects

  every 3 months up to 6 months

Study Arms (1)

ADVAGRAF

EXPERIMENTAL

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)

Interventions

Tacrolimus Sustained-release Capsules (ADVAGRAF) DRUG

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 .

Also known as: ADVAGRAF

ADVAGRAF

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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
• 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
• Frequently recurrence: initial remission with steroid induction therapy, but relapsed 2 or more in 6 months or 3 or more within 12 months
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Yu Xueqing, MD

  Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: March 7, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 2, 2011

Record last verified: 2011-10

Locations

CN (1)