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

The Efficacy of Prednisone Alone and Combination Therapy With Methylprednisolone and Cyclophosphamide in the Treatment of Membranous Nephropathy in Stage I.

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.

Study Overview

• Status: Terminated
• Conditions: Idiopathic Membranous Nephropathy
• Intervention / Treatment: Drug: Prednisone; Drug: MP and CTX

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100050
    • Beijing Friendship Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The pathological examination of renal biopsy 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 eGFR≥25ml/min/1.73m2.And excludeing other causes of renal dysfunction

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Other Names: Glucocorticoid
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; 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.; Other Names: Glucocorticoid and immunosuppressive agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nephrotic syndrome remission ( including complete remission and partial remission)	nephrotic syndrome remission ( including complete remission and partial remission)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood albumin≥30g/L	blood albumin≥30g/L	12 months

Collaborators and Investigators

• Sponsor: Wenhu Liu
• Investigators: Study Director: Zongli Diao, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): January 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: January 13, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: prednisone alone; methylprednisolone and cyclophosphamide; membranous nephropathy in stage I
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Kidney Diseases; Glomerulonephritis, Membranous; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone; Immunosuppressive Agents; Glucocorticoids
• Other Study ID Numbers: 2017-P2-172-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No