NCT03466801

Brief Summary

Multi-center, prospective, randomized, controlled study to verify the efficacy of prednisone alone and combination therapy with methylprednisolone and cyclophosphamide in the treatment of stage I membranous nephropathy.

Trial Health

57
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Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

January 13, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

March 20, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

February 17, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

January 13, 2018

Last Update Submit

February 2, 2022

Conditions

Idiopathic Membranous Nephropathy

Keywords

prednisone alonemethylprednisolone and cyclophosphamidemembranous nephropathy in stage I

Outcome Measures

Primary Outcomes (1)

  • nephrotic syndrome remission ( including complete remission and partial remission)

    nephrotic syndrome remission ( including complete remission and partial remission)

    12 months

Secondary Outcomes (1)

  • blood albumin≥30g/L

    12 months

Study Arms (2)

Group prednisone

EXPERIMENTAL

Prednisone was taken 1mg/kg/d(maximum 60mg/d)for 8 weeks to start.Then decreased 5mg every 2 weeks; When reduced to 40mg,reduced 5mg every 4 weeks. When reduced to 20mg, reduced 2.5mg every 8 weeks until the end.

Drug: Prednisone

Group MP and CTX

ACTIVE COMPARATOR

The first month,Methylprednisolone(MP) was injected for 3 days(weight \>60kg,500mg/d;\<60 kg,300mg/d),and 0.4mg/kg/d for 27 day.The second month,Cyclophosphamide(CTX) orally was 100mg/d for 1 month.And this regimen is repeated for six months.

Drug: MP and CTX

Interventions

PrednisoneDRUG

Prednisone was taken for oral administration with dosage of 1mg/kg/d (maximum 60mg/d) by 8 weeks to start.Then reduced Gradually until the end of the experiment.

Also known as: Glucocorticoid
Group prednisone
MP and CTXDRUG

Methylprednisolone(MP) was injected for 3 day(if weight \>60kg ,500mg/d\<60kg,300mg/d ), methylprednisolone was 0.4mg/kg/d for 27 day.Cyclophosphamide(CTX) orally was 100mg/ d for 1 month.And repeated for six months.

Also known as: Glucocorticoid and immunosuppressive agents
Group MP and CTX

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The pathological examination of renal biopsy was consistent with the early idiopathic membranous nephropathy
  • Meeting one of the following three condition：
  • Urine protein quantitation \>4g/d,or 50% higher than baseline,RASS blocker treat for 6 months without trend of decrease ②Serious or disabling complications related to nephrotic syndrome ③In the 6-12 months after diagnosis of idiopathic membranous nephropathy, serum creatinine increased by more than 30%, while eGFR eGFR≥25ml/min/1.73m2.And excludeing other causes of renal dysfunction

You may not qualify if:

  • Secondary membranous nephropathy
  • Serious complications
  • Considering the effect of cyclophosphamide on the of function of sex gland，all patients with childbearing age or fertility requirement cannot participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, 100050, China

Location

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

PrednisoneGlucocorticoidsImmunosuppressive Agents

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesImmunologic Factors

Study Officials

  • Wenhu Liu, doctor

    Beijing Friendship Hospital

    STUDY CHAIR

  • Zongli Diao

    Beijing Friendship Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2018

First Posted

March 15, 2018

Study Start

March 20, 2018

Primary Completion

January 30, 2019

Study Completion

June 30, 2019

Last Updated

February 17, 2022

Record last verified: 2022-02

Locations

CN(1)