Back to resultsLong-Term Study of Multi-target Therapy as Maintenance Treatment for Lupus Nephritis
Primary Purpose
Lupus Nephritis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Multi-target therapy
Azathioprine
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis
Eligibility Criteria
Inclusion Criteria:
- Patients who signed written informed consent form
- SLE patient, aged between 18-65 years, female or male;
- Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy
- All patients had received induction therapy for 6 months with multi-therapy (FK506 + MMF) or intravenous CTX pulses.
- Patients were recruited when received partial remission or complete remission after 6 months induction therapy.
Complete remission: proteinuria <0.4 g/24h, negative urine sediment, serum albumin >35 g/L, elevated scr <0.3mg/dl, no extra-renal complications; Partial remission: proteinuria <1.0 g/24h, urine RBC <50X104/ml without casts, serum albumin > 30 g/L, elevated Scr <0.3mg/dl,no extra-renal complications.
Exclusion Criteria:
- Patients who didn't sign written informed consent form or could not obey the protocol.
- Patients who didn't received the CR or PR criterion.
- Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
- WBC <3000/mm3 in peripheral blood .
- Patients with central nervous system symptoms. -
Sites / Locations
- Research Institute of Nephrology, Jinling Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multi-target therapy
Azathioprine
Arm Description
(Tarcrolimus+mycophenolate mofetil)
Aza
Outcomes
Primary Outcome Measures
To compare the efficacy and safety of multi-target therapy as maintenance treatment for lupus nephritis with Aza.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01056237
Brief Title
Long-Term Study of Multi-target Therapy as Maintenance Treatment for Lupus Nephritis
Official Title
Research Institute of Nephrology, Jinling Hospital,
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhi-Hong Liu, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
An multi-site, randomized, prospective study to compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment versus CTX- Aza therapy.
Detailed Description
Azathioprine (AZA) has been used for maintenance therapy of lupus nephritis for many years. We compare the efficacy and safety of multi-target therapy as continuous induction and maintenance treatment vs CTX-Aza.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multi-target therapy
Arm Type
Experimental
Arm Description
(Tarcrolimus+mycophenolate mofetil)
Arm Title
Azathioprine
Arm Type
Active Comparator
Arm Description
Aza
Intervention Type
Drug
Intervention Name(s)
Multi-target therapy
Other Intervention Name(s)
Tacrolimus+mycophenolate mofetil
Intervention Description
Tacrolimus (1-3mg/d) and mycophenolate mofetil(0.5-0.75g/d)
Intervention Type
Drug
Intervention Name(s)
Azathioprine
Other Intervention Name(s)
Aza
Intervention Description
1.0-2.0mg/kg/d
Primary Outcome Measure Information:
Title
To compare the efficacy and safety of multi-target therapy as maintenance treatment for lupus nephritis with Aza.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who signed written informed consent form
SLE patient, aged between 18-65 years, female or male;
Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy
All patients had received induction therapy for 6 months with multi-therapy (FK506 + MMF) or intravenous CTX pulses.
Patients were recruited when received partial remission or complete remission after 6 months induction therapy.
Complete remission: proteinuria <0.4 g/24h, negative urine sediment, serum albumin >35 g/L, elevated scr <0.3mg/dl, no extra-renal complications; Partial remission: proteinuria <1.0 g/24h, urine RBC <50X104/ml without casts, serum albumin > 30 g/L, elevated Scr <0.3mg/dl,no extra-renal complications.
Exclusion Criteria:
Patients who didn't sign written informed consent form or could not obey the protocol.
Patients who didn't received the CR or PR criterion.
Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
WBC <3000/mm3 in peripheral blood .
Patients with central nervous system symptoms. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhihong Liu, Master
Organizational Affiliation
Research Institute of Nephrology, Jinling Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institute of Nephrology, Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Learn more about this trial
Long-Term Study of Multi-target Therapy as Maintenance Treatment for Lupus Nephritis
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