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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by Sun Yat-sen University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yanhong Deng, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT02173106
First received: June 23, 2014
Last updated: June 30, 2014
Last verified: June 2014
  Purpose
This prospective, randomized, controlled, multicenter clinical trial will evaluate Opportunity, Validity and Security of Steroids Plus Cyclosporin therapy for patients of Idiopathic Membranous Nephropathy.

Condition Intervention Phase
Idiopathic Membranous Nephropathy
Proteinuria
Spontaneous Remission
Steroid Nephropathy
Cyclosporin Overdose
Drug: steroid & Cyclosporin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Remission of proteinuria (complete or partial) [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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). [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: June 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A: steroid & Cyclosporin
oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months.
Drug: steroid & Cyclosporin
oral methylprednisolone 0.4mg/kg/d and Cyclosporin for 6 months
No Intervention: Group B: no steroid & Cyclosporin
no steroid and cyclosporin and waiting for spontaneous remission for 6 months

Detailed 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.
  Eligibility

Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02173106

Locations
China, Guangdong
Department of Nephrology,Dongguan People's Hospital
Dongguan, Guangdong, China, 523059
Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University
Guangzhou, Guangdong, China, 510260
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510655
Department of Nephrology,Huizhou Municipal Central Hospital
Huizhou, Guangdong, China, 516001
Department of Nephrology,1st Affiliated Hospital,Shenzhen University
Shenzhen, Guangdong, China, 518000
Department of Nephrology,1st People's Hospital of Zhaoqing
Zhaoqing, Guangdong, China, 526020
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Zongpei Jiang, MD &Ph.D The Sixth Affiliated Hospital,Sun Yat-Sen University
  More Information

Responsible Party: Yanhong Deng, The Sixth Affiliated Hospital of Sun Yat-Sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02173106     History of Changes
Other Study ID Numbers: Usix-IMN-001 
Study First Received: June 23, 2014
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Proteinuria
Glomerulonephritis, Membranous
Remission, Spontaneous
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Disease Progression
Disease Attributes
Pathologic Processes
Cyclosporins
Cyclosporine
Methylprednisolone
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Anti-Inflammatory Agents
Antiemetics

ClinicalTrials.gov processed this record on December 08, 2016