Effect of Anti-PLA2R antibody status in primary membranous nephropathy

Recruiting

Conditions: Nephrotic syndrome with diffuse membranous glomerulonephritis,

Registration Number: CTRI/2019/07/020328

Brief Summary: **PRIMARY PURPOSE OF STUDY*:*** Membranous nephropathy (MN) is one of the most common causes of nephrotic syndrome in adults. In majority of patients, it occurs in the absence of an identifiable predisposing disease (e.g. systemic lupus erythematosus {SLE}), infection (e.g. hepatitis B), drug (e.g. non-steroidal anti-inflammatory drug) or malignancy, and is termed primary. Recent evidence suggests that circulating auto-antibodies against podocyte surface antigen Anti-PLA2R and thrombospondin type 1 domain containing 7A (THSD7A) cause the disease in the majority of patients.Presently Anti PLA2R antibody titers are available for diagnosing primary membranous nephropathy. The Anti PLA2 R antibodies are positive in 70-80%% of Primary membranous nephropathy. The literature on response to therapy based on Anti PLA2 receptor antibody is lacking. So our present study would provide insight regarding the role of Anti PLA2 R antibody positivity in predicting the response to therapy and clinical outcomes in MN.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 30

Inclusion Criteria

Those with biopsy proven primary membranous nephropathy.

Exclusion Criteria

1.Pregnancy 2.Presence of active infection 3.Evidence of secondary cause of MN (e.g. hepatitis B, SLE, drugs, malignancy) 4.Estimated GFR (eGFR) â‰¤ 30 mL/min/1.73m2.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete/partial remission at 6 months	6 months
Complete remission (CR) : Proteinuria lesser than 0.3g/day or UPCR lesser than 0.3 mg/mg, with normalization of serum albumin (more than or equal to 3.5g/dL)	6 months
Partial remission : Reduction of 24 hour urine protein (or UPCR) to lesser than 50% of baseline to lesser than 3.5g/day (or UPCR lesser than 3.5mg/mg), but greater than 0.3g/day (or UPCR greater than 0.3mg/mg)	6 months

Secondary Outcome Measures

Name	Time	Method
1.Rate of eGFR decline	2.Anti-PLA2R levels at 6 and 12 months post-therapy

Trial Locations

Locations (1): Kasturba Hospital
🇮🇳
Udupi, KARNATAKA, India
Kasturba Hospital
🇮🇳Udupi, KARNATAKA, India
Dr Indu R Rao
Principal investigator
09592896393
indurrao2006@yahoo.co.in