Decreased immunosuppression in Primary Membranous Nephropathy
- Conditions
- Health Condition 1: N042- Nephrotic syndrome with diffuse membranous glomerulonephritis
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Biopsy-proven primary membranous nephropathy
2. Nephrotic syndrome despite non-immunosuppressive anti-proteinuric therapy for 3 months or membranous nephropathy with deep vein thrombosis (DVT) or requiring hospitalization for complications of nephrotic syndrome
3. Patients showing severe or disabling symptoms related to nephrotic syndrome, or severe hypoalbuminemia ( <2 g/dL) that can be included before the completion of 3-month observation period at the discretion of the investigator independent of the proteinuria value.
1)Patients with eGFR >45 ml/min/1.73m2
2)Prior, active infection including hepatitis B/C and HIV infection,
3)Positive for anti-nuclear factor,
4) Monoclonal proteins in serum/urine,
5)Any suggestion of malignancy on ultrasonography,
6)Hypocomplementaemia,
7)Presence of tubular atrophy and
8)Pre-existing DM,
9)Abnormal liver function tests and secondary MN
10)Any immunosuppressive therapy in the last 12 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remission ratesTimepoint: 12 and 24 months
- Secondary Outcome Measures
Name Time Method 1.Adverse events in both the groups. <br/ ><br>2.The number of patients with an increase = 50% of serum creatinine (SCr) from baseline at 12 and 18 and the end of the follow-up. <br/ ><br>3.The proportion of patients with preserved renal function (estimated GFR = 60 ml/min) in both treatment arms after the treatment period. <br/ ><br>4.Serum levels of anti-phospholipase A2 receptor antibodies (anti-PLA2R), before of treatment and at 3, 6, 9, 12 and18 months of study, in both treatment arms. <br/ ><br>5.CR and PRTimepoint: 12 and 24 months