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Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

Primary Purpose

Nephritis, Lupus

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Tripterygium wilfordii Hook F

Cyclophosphamide

About this trial

This is an interventional treatment trial for Nephritis, Lupus focused on measuring Lupus Nephritis, Cyclophosphamide, Tripterygium

Eligibility Criteria

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

Inclusion Criteria:

Age 18-65 years with informed consent
SLE defined by meeting 4 or more ACR classification criteria
Biopsy-proven active proliferative lupus glomerulonephritis ISN classification Class III or IV
Active renal disease

Exclusion Criteria:

Pregnant, lactating or further fertility requirements
Serum creatinine > 3 mg/dL
Serum ALT or AST > 3 times upper limit of normal
Severe, progressive renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease
Previous treated with cyclophosphamide or T2.
Not discontinuing MMF, azathioprine, leflunomide, methotrexate, calcineurin inhibitor before 1 month of randomization.
Active or chronic infection, including HIV, HCV, HBV, tuberculosis
Patient with malignancy

Sites / Locations

Deptment of Rheumatology, Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

GC+CYC

GC+T2

Arm Description

Patients were treated with Glucocorticosteroid and Cyclophosphamide.

Patients were treated with Glucocorticosteroid and oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).

Outcomes

Primary Outcome Measures

Renal Response

The proportion of patients achieving Complete Response (CR) and Partial Response(PR).

Secondary Outcome Measures

Renal Function

The change in glomerular filtration rate(GFR) from baseline to week 24.

Serum Albumin Level

The change in serum albumin level from baseline to week 24.

Complement

The change in complement components from baseline to week 24, including: CH50(total complement activity), C3 and C4 level measured by nephelometry.

Anti-dsDNA

The change in anti-dsDNA antibody titers from baseline to week 24.

Full Information

NCT ID

NCT01646736

First Posted

July 18, 2012

Last Updated

July 19, 2012

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01646736

Brief Title

Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

Official Title

Evaluation of Efficacy and Safety of Glucocorticosteroid Combined With Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of Patients With Lupus Nephritis.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Unknown status

Study Start Date

July 2012 (undefined)

Primary Completion Date

July 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Evaluation the clinical efficacy and safety profile of glucocorticosteroid combined with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of patients with lupus nephritis. Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nephritis, Lupus

Keywords

Lupus Nephritis, Cyclophosphamide, Tripterygium

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GC+CYC

Arm Type

Placebo Comparator

Arm Description

Patients were treated with Glucocorticosteroid and Cyclophosphamide.

Arm Title

GC+T2

Arm Type

Experimental

Arm Description

Patients were treated with Glucocorticosteroid and oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).

Intervention Type

Drug

Intervention Name(s)

Tripterygium wilfordii Hook F

Intervention Description

Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

Cyclophosphamide 1.0 intravenous every month.

Intervention Type

Drug

Intervention Name(s)

Intervention Description

Prednisone or equivalent 1 mg/kg/d(up to 60 mg), gradually tapering to 7.5mg/d in 24 weeks.

Primary Outcome Measure Information:

Title

Renal Response

Description

The proportion of patients achieving Complete Response (CR) and Partial Response(PR).

Time Frame

24 weeks.

Secondary Outcome Measure Information:

Title

Renal Function

Description

The change in glomerular filtration rate(GFR) from baseline to week 24.

Time Frame

24 weeks

Title

Serum Albumin Level

Description

The change in serum albumin level from baseline to week 24.

Time Frame

24 weeks

Title

Complement

Description

The change in complement components from baseline to week 24, including: CH50(total complement activity), C3 and C4 level measured by nephelometry.

Time Frame

24 weeks

Title

Anti-dsDNA

Description

The change in anti-dsDNA antibody titers from baseline to week 24.

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-65 years with informed consent SLE defined by meeting 4 or more ACR classification criteria Biopsy-proven active proliferative lupus glomerulonephritis ISN classification Class III or IV Active renal disease Exclusion Criteria: Pregnant, lactating or further fertility requirements Serum creatinine > 3 mg/dL Serum ALT or AST > 3 times upper limit of normal Severe, progressive renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease Previous treated with cyclophosphamide or T2. Not discontinuing MMF, azathioprine, leflunomide, methotrexate, calcineurin inhibitor before 1 month of randomization. Active or chronic infection, including HIV, HCV, HBV, tuberculosis Patient with malignancy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hua Chen, MD

Phone

+861069158797

chenhua@pumch.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fengchun Zhang, MD

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Deptment of Rheumatology, Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fengchun Zhang, MD

Phone

861069158792

ZhangFCcra@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Fengchun Zhang, MD

12. IPD Sharing Statement

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Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

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