NCT01288664

Brief Summary

This is a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) for the induction therapy of Lupus Nephritis (LN) (V, III +V, IV+V).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 12, 2014

Status Verified

December 1, 2013

Enrollment Period

1.9 years

First QC Date

February 1, 2011

Last Update Submit

February 10, 2014

Conditions

Lupus Nephritis

Keywords

Lupus NephritisTacrolimusInduction Phase

Outcome Measures

Primary Outcomes (1)

  • Remission rate (complete or partial remission)

    6 months

Secondary Outcomes (5)

  • proteinuria

    every 3 months,up to 6 months

  • Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores

    every 3 months, up to 6 months

  • Number of participants with adverse events as a measure of safety and tolerability

    every 3 months, up to 6 months

  • renal function

    every 3 months, up to 6 months

  • relapse

    every 3 months, up to 6 months

Study Arms (1)

ADVAGRAF

EXPERIMENTAL

Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase for 6 months

Drug: ADVAGRAF

Interventions

ADVAGRAFDRUG

Tacrolimus Sustained-release Capsules (ADVAGRAF) Started: 0.05-0.1mg/kg/d, one time per day, the blood level:5-10ng/ml in induction phase.

Also known as: ADVAGRAF:Tacrolimus Sustained-release Capsules
ADVAGRAF

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects of either sex, 14-65 years of age;
  • Diagnosis of systemic lupus erythematosus (SLE) according to the albumin-creatinine ratio (ACR) criteria (1997);
  • Kidney biopsy within the 6 months prior to study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class V, III +V, IV+V;
  • LN (Class IV+V): proteinuria \> 1g/24hr or Scr \> 1.3 mg/dl or active urinary sediment (erythrocyte cast, \> 5 white blood cell count (WBC) /high power field (hpf)(excluding infection ), \> 5 red blood cell count (RBC)/hpf;
  • LN (Class V or III +V ): proteinuria \> 2g/24hr or Scr \> 1.3 mg/dl;
  • Provision of written informed consent by subject or guardian

You may not qualify if:

  • Inability or unwillingness to provide written informed consent
  • Usage of immunosuppression therapy (MMF, Cyclophosphamide (CTX), Cyclosporine A (CysA), methotrexate (MTX) ect) for more than 1 week within 1 month or Pulse intravenous MP treatment prior to recruitment
  • Scr \> 4mg/dl (354umol/L)
  • Needing pulse intravenous Methylprednisolone (MP) or intravenous immunoglobulin
  • Lupus encephalopathy
  • Diagnosed diabetes mellitus (DM); Malignant tumors (except fully cured basal cell carcinoma)
  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Yu Xueqing, MD

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

    PRINCIPAL INVESTIGATOR
0

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

February 2, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 12, 2014

Record last verified: 2013-12

Locations

CN(1)