Mycophenolate Mofetil Plus Steroid in the Treatment Of Patients With Progressive Idiopathic Membranous Nephropathy

NCT03170323 | Unknown Phase 4

• 1 other identifier: GGH2016430H
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in adults. There are few randomized clinical trials regarding the therapeutic effect of mycophenolate mofetil in patients with Idiopathic membranous nephropathy. This study aims to evaluate whether treatment with mycophenolate mofetil is non-inferior to cyclosporins in inducing long-term remission (complete or partial) of proteinuria in patients with idiopathic membranous nephropathy.

Conditions

Idiopathic Membranous Nephropathy

Outcome Measures

Primary Outcomes (2)

• Complete Remission

  Urinary protein excretion\<0.3 g/d (uPCR\<300 mg/g or \<30 mg/mmol), confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal serum creatinine.

  after treatment for 1 year.

• Partial Remission

  Urinary protein excretion \<3.5 g/d (uPCR \<3500 mg/g or \<350 mg/mmol) and a 50% or greater reduction from peak values;confirmed by two values at least 1 week apart, accompanied by an improvement or normalization of the serum albumin concentration and stable serum creatinine.

  after treatment for 1 year.

Secondary Outcomes (2)

• estimated Glomerular Filtration Rate

  after treatment for 1 year

• serum creatinine

  after treatment for 1 year

Study Arms (2)

Mycophenolate mofetil

EXPERIMENTAL

Drug: Mycophenolate mofetil, high dose steroid Duration: 1 year

Drug: Mycophenolate Mofetil

Cyclosporin

ACTIVE COMPARATOR

Drug: Cyclosporin, low dose steroid Duration: 1 year

Drug: Cyclosporins

Interventions

Mycophenolate Mofetil DRUG

steroid 1mg/kg/d and Mycophenolate mofetil 500mg bid

Mycophenolate mofetil

Cyclosporins DRUG

steroid 0.15mg/kg/d and Cyclosporin 3-5mg/kg/d

Cyclosporin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who provided informed consent
• Patients who are diagnosed as membranous nephropathy by renal biopsy,and other secondary factors are excluded
• years of age or older, male or female
• hours urine protein or spot urine protein/creatinine ratio \> 8.0 g/day at least for twice confirmed
• The patients that satisfy more than three of following items are included even if proteinuria is less than 8 grams per day:
• estimated glomerular filtration rate(eGFR) \< 60 ml/min/1.73m2
• Hypertension (BP above 140/90millimetre of mercury or BP above 120/80millimetre of mercury in patients taking anti-hypertensive agents)
• hours urine protein or spot urine protein/creatinine ratio \> 5.0 g/day
• Serum albumin (g/dL) \< 3.0

You may not qualify if:

• Severe infective disease
• Allergy history to clinical trial medication and acute or chronic allergy for 4 weeks recently.
• Clinical history of treatment with other immunosuppressive medication
• Probability of pregnancy, breast feeding woman
• Uncontrolled hypertension (more than 160/100 millimetre of mercury )
• estimated glomerular filtration rate(eGFR)\<30 ml/min/1.73m2。
• Abnormal liver function test (more than 3 times above compared with normal value)
• Absolute neutrophil count \<1,500/mm3 or leukocyte \<2,500/mm3 or platelets \<100,000/mm3
• Secondary membranous nephropathy
• Expected life expectancy is less than 1 year
• The researchers evaluated that the patient's compliance was not appropriate for the trial
• Previous or present history of cancer and have risk of recurrence or metastasis

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, China

RECRUITING

Related Publications (1)

• von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.

  PMID: 34778952 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

Mycophenolic Acid; Cyclosporins

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• xinling Liang, M.D.,PH.D

  Nephrology Dept,Guangdong General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xinling Liang, M.D.,PH.D

CONTACT

13808819770; xinlingliang_ggh@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Drug: Mycophenolate mofetil, high dose steroid Drug: Cyclosporin, low dose steroid

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 31, 2017
• Study Start: July 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 18, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)