search
Back to results

Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Phase Treatment in Lupus Nephritis

Primary Purpose

Lupus Nephritis

Status
Withdrawn
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
ADVAGRAF
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring Lupus Nephritis, Tacrolimus, Induction Phase

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects of either sex, 14-65 years of age;
  2. Diagnosis of systemic lupus erythematosus (SLE) according to the albumin-creatinine ratio (ACR) criteria (1997);
  3. 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;
  4. 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;
  5. LN (Class V or III +V ): proteinuria > 2g/24hr or Scr > 1.3 mg/dl;
  6. Provision of written informed consent by subject or guardian

Exclusion Criteria:

  1. Inability or unwillingness to provide written informed consent
  2. 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
  3. Scr > 4mg/dl (354umol/L)
  4. Needing pulse intravenous Methylprednisolone (MP) or intravenous immunoglobulin
  5. Lupus encephalopathy
  6. Diagnosed diabetes mellitus (DM); Malignant tumors (except fully cured basal cell carcinoma)
  7. History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study
  8. Any Active systemic infection or history of serious infection within one month of entry
  9. known infection with HIV, hepatitis B, or hepatitis C
  10. Known hypersensitivity or contraindication to tacrolimus, corticosteroids
  11. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening
  12. Pregnancy, nursing or use of a non-reliable method of contraception.

Sites / Locations

  • The First Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADVAGRAF

Arm Description

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

Outcomes

Primary Outcome Measures

Remission rate (complete or partial remission)

Secondary Outcome Measures

proteinuria
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores
SLEDAI (Systemic Lupus Erythematosus Disease Activity Index, Bombardier et al, 1992).
Number of participants with adverse events as a measure of safety and tolerability
Adverse events,including infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance, etc.
renal function
relapse

Full Information

First Posted
February 1, 2011
Last Updated
February 10, 2014
Sponsor
Sun Yat-sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT01288664
Brief Title
Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Phase Treatment in Lupus Nephritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Withdrawn
Why Stopped
sponsor withdraw from this study
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
Lupus Nephritis, Tacrolimus, Induction Phase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADVAGRAF
Arm Type
Experimental
Arm Description
Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase for 6 months
Intervention Type
Drug
Intervention Name(s)
ADVAGRAF
Other Intervention Name(s)
ADVAGRAF:Tacrolimus Sustained-release Capsules
Intervention Description
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.
Primary Outcome Measure Information:
Title
Remission rate (complete or partial remission)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
proteinuria
Time Frame
every 3 months,up to 6 months
Title
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores
Description
SLEDAI (Systemic Lupus Erythematosus Disease Activity Index, Bombardier et al, 1992).
Time Frame
every 3 months, up to 6 months
Title
Number of participants with adverse events as a measure of safety and tolerability
Description
Adverse events,including infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance, etc.
Time Frame
every 3 months, up to 6 months
Title
renal function
Time Frame
every 3 months, up to 6 months
Title
relapse
Time Frame
every 3 months, up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Xueqing, MD
Organizational Affiliation
Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Phase Treatment in Lupus Nephritis

We'll reach out to this number within 24 hrs