ClinicalTrials.gg
TerminatedNCT03466801Updated Feb 17, 2022

The Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I.

An interventional study of Prednisone and MP and CTX in Idiopathic Membranous Nephropathy, sponsored by Wenhu Liu. Terminated at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-17.

Sponsored by Wenhu Liu · Not applicable, Interventional, and Treatment

Why this study was terminated
the clinical significance is little
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 60 studies in Glomerulonephritis, Membranous with a site in China — 29 open to participants now, 37 under way, 10 of them phase 3. Glomerulonephritis, Membranous · China.

Enrollment
47th of 50
6 · median 77
Started
2018
with 4 others
No phase
10 of 60
1 open now
Registered
12th of 60
by date

Among the 60 studies in Glomerulonephritis, Membranous with a site in China, this one is the 47th largest by enrollment of the 50 interventional ones, is one of 5 that started in 2018, is one of 10 with no phase, and was the 12th registered.

By phase

60 studies; the count open now beside each. This study's row is marked.

Phase 211 · 6 open
No phasethis study10 · 1 open
Observational10 · 4 open
Phase 39 · 4 open
Phase 17 · 6 open
Phase 47 · 4 open
Phase 2/34 · 3 open
Phase 1/22 · 1 open

By the year they started

First in 1990; this study’s year is marked. 5 started in 2018.

Size and results

Median enrollment 77 across the 50 interventional studies, 241 across the 10 observational. Of the 13 that completed or were terminated, 1 (8%) have results posted.

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02

Study 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.

Read the detailed description

Idiopathic membranous nephropathy (IMN) is one of the most common cause of adult nephrotic syndrome. Prednisolone and methylprednisolone are essential drugs for IMN. However, there are no recommendations for the treatment of IMN in China. KDIGO guidelines recommend combination therapy with methylprednisolone and cyclophosphamide as first-line therapy of IMN, but there is a large side effect of cyclophosphamide.There were retrospective study showed that the use of glucocorticoid hormones (including prednisone and methylprednisolone) alone may be effective in patients with membranous nephropathy in Asia, but there is no high quality evidence of evidence-based medicine.The study is a randomized prospective controlled multi-centered trial,to compare the efficacy of prednisone alone and combination therapy with methylprednisolone and cyclophosphamide in the treatment of membranous nephropathy in stage I.

03

Conditions studied

  • Idiopathic Membranous Nephropathy

Keywords

  • prednisone alone
  • methylprednisolone and cyclophosphamide
  • membranous nephropathy in stage I
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The pathological examination of renal was consistent with the early idiopathic membranous nephropathy
  2. 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≥25ml/min/1.73m2.And excludeing other causes of renal dysfunction

Exclusion criteria

Exclusion Criteria:

  1. Secondary membranous nephropathy
  2. Serious complications
  3. 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Group prednisone

    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

  • Active comparator
    Group MP and CTX

    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

  • 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

  • DrugMP and CTX

    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

06

What researchers measure

Primary outcomes

  1. nephrotic syndrome remission ( including complete remission and partial remission)

    nephrotic syndrome remission ( including complete remission and partial remission)

    Time frame: 12 months

Secondary outcomes

  1. blood albumin≥30g/L

    blood albumin≥30g/L

    Time frame: 12 months

07

Study locations

1 site
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, 100050, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Jan 2019, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2018
First posted
Mar 15, 2018
StartActual
Mar 20, 2018
Primary completionActual
Jan 30, 2019
CompletionActual
Jun 30, 2019
Last update
Feb 17, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03466801
Lead sponsor
Wenhu Liu
Responsible party
Wenhu Liu (Professor, Beijing Friendship Hospital) — Sponsor-investigator
First posted
Mar 15, 2018
Start date
Mar 20, 2018
Primary completion
Jan 30, 2019
Completion
Jun 30, 2019
Last update
Feb 17, 2022

Study contacts

Wenhu Liu, doctor
study chair · Beijing Friendship Hospital
Zongli Diao
study director · Beijing Friendship Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Prednisone

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