Efficacy and Safety of Tripterygium Wilfordii in Patients... | NCT01646736

Studies
Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

NCT01646736

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Jul 23, 2012Estimated

Enrollment

130Estimated

Phase

Phase 2Phase 3

Conditions

Nephritis, Lupus

Interventions

Tripterygium wilfordii Hook F
Cyclophosphamide
GC

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jul 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Jul 18, 2012

First Submission Date that Met QC Criteria

Jul 18, 2012

First Posted Date

Jul 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2012

Last Update Posted Date

Jul 23, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fengchun Zhang, Professor, Peking Union Medical College HospitalPrincipal Investigator

Lead Sponsor

Peking Union Medical College HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GC+CYC	Placebo Comparator	Patients were treated with Glucocorticosteroid and Cyclophosphamide.	Drug: Cyclophosphamide Drug: GC
GC+T2	Experimental	Patients were treated with Glucocorticosteroid and oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).	Drug: Tripterygium wilfordii Hook F Drug: GC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tripterygium wilfordii Hook F	Drug	Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.	GC+T2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Renal Response	The proportion of patients achieving Complete Response (CR) and Partial Response(PR).	24 weeks.

Secondary Outcomes

Measure	Description	Time Frame
Renal Function	The change in glomerular filtration rate(GFR) from baseline to week 24.	24 weeks
Serum Albumin Level	The change in serum albumin level from baseline to week 24.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hua Chen, MD	Contact	+861069158797		chenhua@pumch.cn

Overall Officials

Name	Affiliation	Role
Fengchun Zhang, MD	Peking Union Medical College Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deptment of Rheumatology, Peking Union Medical College Hospital	Recruiting	Beijing	Beijing Municipality	100032	China

Condition Browse Module

MeSH Terms

ID	Term
D008181	Lupus Nephritis

Ancestor Terms

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003520	Cyclophosphamide

Ancestor Terms

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated

Browse Leaves

Not provided

Browse Branches

Not provided