NCT01646736

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 23, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

July 18, 2012

Last Update Submit

July 19, 2012

Conditions

Nephritis, Lupus

Keywords

Lupus NephritisCyclophosphamideTripterygium

Outcome Measures

Primary Outcomes (1)

  • Renal Response

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

    24 weeks.

Secondary Outcomes (4)

  • Renal Function

    24 weeks

  • Serum Albumin Level

    24 weeks

  • Complement

    24 weeks

  • Anti-dsDNA

    24 weeks

Study Arms (2)

GC+CYC

PLACEBO COMPARATOR

Patients were treated with Glucocorticosteroid and Cyclophosphamide.

Drug: CyclophosphamideDrug: GC

GC+T2

EXPERIMENTAL

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

Drug: Tripterygium wilfordii Hook FDrug: GC

Interventions

Tripterygium wilfordii Hook FDRUG

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

GC+T2
CyclophosphamideDRUG

Cyclophosphamide 1.0 intravenous every month.

GC+CYC
GCDRUG

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

GC+CYCGC+T2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deptment of Rheumatology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Cyclophosphamide

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

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Fengchun Zhang, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Chen, MD

CONTACT

+861069158797chenhua@pumch.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 20, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2013

Study Completion

December 1, 2013

Last Updated

July 23, 2012

Record last verified: 2012-07

Locations

CN(1)