A Controlled Study of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy

Proteinuria Clinical Trial

Official title:

Opportunity, Validity and Security of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02173106
• Other study ID #: Usix-IMN-001
• Status: Recruiting
• Phase: Phase 2
• First received: June 23, 2014
• Last updated: June 30, 2014
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2014
• Source: Sun Yat-sen University
• Contact: Zongpei Jiang, MD&Ph D
• Phone: 8620-38379727
• Email: jx.home[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This prospective, randomized, controlled, multicenter clinical trial will evaluate Opportunity, Validity and Security of Steroids Plus Cyclosporin therapy for patients of Idiopathic Membranous Nephropathy.

Description:

Idiopathic membranous nephropathy is a main reason for nephropathy. Since it can get spontaneous remission, in KDIGO, it is recommend that initial therapy should be started only in patients with nephrotic syndrome and when at least the following condition is met:urinary protein excretion persistently exceeds 4g/d and remains at over 50% of the baseline value,and does not show progressive and antiproteinuric therapy during an observation period of at least 6 months. But many retrospective researches reported that using steroids and immunosuppressive agents were better than waiting for spontaneous remission. There were few prospective, randomized, controlled research on whether it is better that begin to use steroids and immunosuppressive agent early without waiting for 6 months. In our study,we evaluate the validity and security of steroids plus cyclosporin therapy in idiopathic membranous nephropathy. This will be a prospective, randomized, controlled, multicenter study. Patients in treatment group will receive oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months. Patients in control group will waiting for spontaneous remission for 6 months,if there were no spontaneous remissions, patients in control group will receive oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months. After followed-up for 6 months the curative and side effect of steroid plus cyclosporin therapy in the early stage of idiopathic membranous nephropathy will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 14~75 years, regardless of gender without secondary reason, idiopathic membranous nephropathy by renal biopsy

• Average urinary protein excretion of at least3.5g/24h on two successive examinations,or plasma albumin <30g/l

• eGFR=40ml/min/1.73m2

• Willingness to sign an informed consent

Exclusion Criteria:

• Secondary membranous nephropathy such as systemic lupus erythematosus, hepatitis B -associated nephritis

• Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX?MMF?CsA?FK506).

• Cirrhosis, chronic active liver disease

• History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease)

• Any Active systemic infection or history of serious infection within one month.

• Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure, chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases)

• Active tuberculosis

• Known allergy, contraindication or intolerance to the steroids

• Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception

• Malignant tumors

• Excessive drinking or drug abuse

• Mental aberrations

• Current or recent (within 30 days) exposure to any other investigational drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cyclosporin Overdose
• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases
• Proteinuria
• Spontaneous Remission
• Steroid Nephropathy

Intervention

Drug:
• steroid & Cyclosporin
oral methylprednisolone 0.4mg/kg/d and Cyclosporin for 6 months

Locations

Country	Name	City	State
China	Department of Nephrology,Dongguan People's Hospital	Dongguan	Guangdong
China	Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University	Guangzhou	Guangdong
China	Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	Department of Nephrology,Huizhou Municipal Central Hospital	Huizhou	Guangdong
China	Department of Nephrology,1st Affiliated Hospital,Shenzhen University	Shenzhen	Guangdong
China	Department of Nephrology,1st People's Hospital of Zhaoqing	Zhaoqing	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission of proteinuria (complete or partial)		up to 6 months	Yes
Secondary	Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation).		up to 6 months	Yes